Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication.

BACKGROUND: As a key treatment goal for patients with symptomatic peripheral artery disease (PAD), improving health status has also become an important end point for clinical trials and performance-based care. An understanding of patient factors associated with 1-year PAD health status is lacking in patients with PAD. METHODS: The health status of 1073 consecutive patients with symptomatic PAD in the international multicenter PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry was measured at baseline and 1 year with the Peripheral Artery Questionnaire (PAQ). The association of 47 patient characteristics with 1-year PAQ scores was assessed using a random forest algorithm. Variables of clinical significance were retained and included in a hierarchical multivariable linear regression model predicting 1-year PAQ summary scores. RESULTS: The mean age of patients was 67.7 ± 9.3 years, and 37% were female. Variables with the highest importance ranking in predicting 1-year PAQ summary score were baseline PAQ summary score, Patient Health Questionnaire-8 depression score, Generalized Anxiety Disorder-2 anxiety score, new onset symptom presentation, insurance status, current or prior diagnosis of depression, low social support, initial invasive treatment, duration of symptoms, and race. The addition of 19 clinical variables in an extended model marginally improved the explained variance in 1-year health status (from R2 0.312 to 0.335). CONCLUSIONS: Patients' 1-year PAD-specific health status, as measured by the PAQ, can be predicted from 10 mostly psychosocial and socioeconomic patient characteristics including depression, anxiety, insurance status, social support, and symptoms. These characteristics should be validated and tested in other PAD cohorts so that this model can inform risk adjustment and prediction of PAD health status in comparative effectiveness research and performance-based care.

Illness beliefs relation to physical activity and quality of life in patients with peripheral arterial disease.

Intermittent claudication is the most common symptom of Peripheral Arterial Disease (PAD) and is associated with decreased quality of life (QoL) due to walking impairment. The level of threat attributed to the disease affects QoL and physical activity. This study explores beliefs and illness drawings, and their relationship with quality of life and physical activity in patients undergoing conservative treatment for PAD. A cross-sectional study was carried out including 119 patients with PAD and Intermittent Claudication, in which patients were asked to freely draw their disease and 33 agreed to participate. The profile of beliefs about PAD is characterized by a low level of threat. Belief in the emotional impact of the disease, representations about the consequences and concern about the disease were associated with worse quality of life; the belief of having a high personal control over the disease was associated with more physical activity. The analysis of the disease drawings revealed three categories: extension of the disease (category 1), location and representations of the disease (category 2), and level of detail and complexity of the drawings (category 3). Greater disease extent was associated with more disease symptoms (IPQ 6) (rs = 0.399, p = .021). It is necessary to address beliefs and representations about the disease in consultations with patients with PAD. Patient drawings are a useful, practical, and free tool that does not require a lot of time and can facilitate the approach of health professionals to patient training and education.

Cardiovascular Rehabilitation Increases Walking Distance in Patients With Intermittent Claudication. Results of the CIPIC Rehab Study: A Randomised Controlled Trial.

OBJECTIVE: To examine whether a cardiac rehabilitation programme in a community based setting for patients with intermittent claudication (IC) affects walking ability, quality of life, and changes in health behaviour. The trial investigated a cross sector cardiovascular rehabilitation programme compared with usual care for patients having non-operative management. METHODS: The trial allocated 118 patients, with 1:1 individual randomisation to either an intervention or control group. Data were collected at a department of vascular surgery and at a healthcare centre in Denmark. The rehabilitation intervention consisted of usual care plus 12 weeks of exercise training, pedometer, health education, and text messages. The primary outcome was maximum walking distance at six months measured by treadmill walking test. The secondary outcomes were maximum walking distance at 12 months and pain free walking distance measured by treadmill walking test, healthy diet, level of physical activity, and quality of life (QoL) at six and 12 months. RESULTS: In the intervention group, 46 participants were analysed, with 47 in the control group. Following three months of rehabilitation, a 37% difference (95% CI 1.10 - 1.70; p = .005) was found between groups in maximum walking distance at six and 12 months, in favour of the intervention group. The same positive effect was found in physical activity, QoL, and healthy diet, but was not statistically significant in pain free walking distance and smoking. CONCLUSION: A specialised community based cardiac rehabilitation programme for patients with IC showed statistically and clinically significant effects on maximum walking distance, physical activity, quality of life, and healthy diet, but not on pain free walking distance and smoking, compared with usual care without rehabilitation.

Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial.

BACKGROUND: Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof-of-concept study and RCT were conducted. METHODS: In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five-level instrument (EQ-5D-5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30-min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements. RESULTS: Study 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ-5D-5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time-adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent. CONCLUSION: Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).

ANTECEDENTES: Los programas de ejercicio supervisado (supervised exercise programmes, SEP) para la claudicación intermitente (intermittent claudication, IC) tienen un acceso y un cumplimiento deficientes. La estimulación eléctrica neuromuscular (neuromuscular electrical stimulation, NMES) puede ser una alternativa clínicamente efectiva. Se realizó un estudio de prueba de concepto y un ensayo controlado aleatorizado. MÉTODOS: Estudio 1: Veinte pacientes elegibles se sometieron a una evaluación inicial que incluía una prueba en la cinta de correr para la distancia inicial de claudicación (initial claudication distance, ICD) y la distancia máxima de claudicación (maximum claudication distance, MCD), EuroQoL-5D (EQ-5D), valoración mediante el cuestionario de claudicación intermitente (intermittent claudication questionnaire, ICQ), y hemodinámica por ecografía de la arteria femoral superficial. Después de familiarizarse con el dispositivo NMES, los participantes se sometieron a una sesión de estimulación de 30 minutos con el registro concomitante de medidas hemodinámicas a los 15 minutos y después del cese del dispositivo. Se realizaron mediciones repetidas después de 6 semanas de uso diario de NMES. Estudio 2: Se reclutaron 42 pacientes que tras una evaluación inicial y posterior aleatorización al azar en línea, se asignaron al Grupo A, utilizando SEP solamente; o al el Grupo B, con tratamiento NMES complementario durante 6 semanas seguido de medidas repetidas. RESULTADOS: El estudio 1 mostró una mejoría significativa de la MCD (46%, P < 0,0001) y de la ICD (71%, P < 0.004). El ensayo clínico mostró un beneficio coadyuvante significativo de NMES en la ICD (46%, P = 0,014). Se observaron mejorías en la puntuación del ICQ (9 puntos, P < 0,01) y del EQ-5D (P < 0,05) en el estudio 1, con un beneficio coadyuvante significativo de NMES en la puntuación del ICQ (11 puntos, P < 0,05). El flujo de volumen de sangre (CC/min) y TAMV (cm/s) aumentaron significativamente con el dispositivo en funcionamiento (P < 0,05). El cumplimiento global de la NMES superó el 95%. CONCLUSIÓN: La plataforma de NMES para el pie mejora significativamente las distancias de caminar en la claudicación intermitente cuando se usa de forma independiente y también proporciona un beneficio complementario al ejercicio supervisado en la distancia caminada sin dolor. La mejora del flujo sanguíneo puede ser un mecanismo para explicar estos resultados.

A Comparison of Quality of Life in Elderly Patients with Intermittent Claudication and Chronic Limb-Threatening Ischemia.

BACKGROUND: Intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) are both associated with a decreased health status and possibly quality of life (QOL). A better understanding of the differences in QOL between patients with IC and CLTI could be of additional value in shared decision-making. The aim of this study was to compare the QOL at baseline between patients with IC and patients with CLTI. METHODS: The study population was based on 2 study cohorts, 1 cohort consisted of patients with IC (ELECT registry) and the other cohort of patients with CLTI (KOP-study). Patients with an age of ≥70 years were included. QOL at baseline was measured by the WHOQOL-BREF questionnaire. Nonresponders were excluded from data analyses. Student's t-tests and analysis of covariance (ANCOVA) analyses were used to compare QOL between the 2 groups. Outcomes of the ANCOVA analyses were expressed as estimated marginal means. RESULTS: In total, 308 patients were included, 115 patients with IC and 193 patients with CLTI. Patients with CLTI were older (median age 80 years vs. 75 years, P < 0.001) and had more comorbidities. Patients with IC had a statistically significant higher QOL regarding physical health (mean 13.7 [standard deviation (SD) 2.3] vs. 10.8 [SD 2.8], P < 0.001), psychological health (mean 15.3 [SD 2.1] vs. 14.1 [SD 2.4], P < 0.001), environment (mean 16.3 [SD 2.4] vs. 15.5 [SD 2.0], P < 0.002), and the overall domain (mean 3.5 [SD 0.7] vs. 3.1 [SD 0.9], P < 0.001). After correcting for the confounding effect of age and sex, patients with IC still had a statistically significant higher QOL in the physical, psychological, environment, and overall domain. CONCLUSIONS: Patients with IC had a significantly higher QOL in the physical, psychological, environment, and overall domains of the WHOQOL-BREF questionnaire compared with patients with CLTI. This underlines the importance of strategies that reduce disease progression as disease progression is associated with a decrease in QOL.

Treadmill Measured vs. Questionnaire Estimated Changes in Walking Ability in Patients With Peripheral Artery Disease.

OBJECTIVE: Determining the maximum walking time (MWT) using the treadmill test is the gold standard method for evaluating walking capacity and treatment effect in patients with peripheral arterial disease (PAD). However, self reported functional disability is important when assessing quality of life. Changes in the Walking Estimated Limitation Calculated by History (WELCH) questionnaire scores were compared with the MWT. METHODS: A cross sectional study was performed in patients with intermittent claudication. The treadmill test (3.2 km/h; 10% gradient) and WELCH questionnaire were administered to all patients for objective evaluation of walking capacity. Given the log normal distribution of these parameters in patients with PAD, a log transformation was applied to the WELCH score (LnW) and maximum walking time (LnT). The responsiveness of the WELCH score was determined using mean changes and correlation coefficients of LnW and LnT changes. The effect of time on the "estimated minus real" (E - R) changes (LnW - change minus LnT - change) was assessed after categorisation of patients into various test-retest intervals. Patients who underwent lower limb revascularisation between the two tests and those who underwent medical treatment only were analysed. RESULTS: Correlation coefficients between LnW and LnT for tests 1 and 2 were r = 0.514 and r = 0.503, respectively (p < .001, for both). Correlation for LnW change vs. LnT change was 0.384 (p < .001). E - R was positive only early after surgery. E - R was negative for all test-retest intervals >1 year in revascularised and non-revascularised patients. CONCLUSION: Changes in WELCH scores correlated with changes observed on the treadmill in patients with intermittent claudication. For long test-retest intervals, WELCH changes tended to overestimate the worsening of walking impairment as compared with the measured difference observed in both revascularised and non-revascularised patients. A shortlived "honeymoon" (overestimation of the benefit for the shortest test-retest interval) was observed only in revascularised patients.

Delayed gratification and adherence to exercise among patients with claudication.

Few studies have explicitly identified factors that explain an individual's willingness to engage in community-based exercise for claudication. Identifying the unique characteristics of those inclined toward physical activity would inform interventions that encourage walking. We examined the utility of behavioral economics-related concepts in understanding walking among Veterans with claudication. Patients who received care at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, were surveyed on symptom severity, behavioral economics, stress, and depression. The primary outcome was a binary variable measuring current walking for exercise and defined as walking for at least 30 minutes every day. Multivariable logistic regression models were used to identify variables, both clinically and statistically significant, at a p-value < 0.05. Between April 2017 and March 2018, we received 148 (30%) responses. A total of 35% (n = 51) of respondents indicated that they walked recreationally for exercise compared to 65% (n = 94) who did not. Characteristics that were significantly associated with walking included regularly saving money (adjusted odds ratio (aOR) = 10.7, p = 0.001), seeking complex problem-solving (aOR = 0.12, p = 0.002), and severe symptoms (aOR = 0.24, p = 0.017). Individuals describing a preference for the future rather than immediate benefit also reported currently walking for exercise. Defining the characteristics of those who exercise may help inform strategies designed to increase walking among those who do not adhere to recommendations.

Agreement between self-reports, proxy-reports and the National Patient Register regarding diagnoses of cardiovascular disorders and diabetes mellitus in a population-based sample of 80-year-olds.

BACKGROUND: cognitive impairment is common among older adults, necessitating the use of collateral sources in epidemiological studies involving this age group. The objective of this study was to evaluate agreement between self- and proxy-reports of cardiovascular disorders and diabetes mellitus in a population-based sample of 80-year-olds. Further, both self- and proxy-reports were compared with hospital register data. METHODS: data were obtained from the Gothenburg H70 Birth Cohort Studies in Sweden. The study had a cross-sectional design and information was collected through semi-structured interviews in 2009-2012 from participants born in 1930 (N = 419) and their proxy informants. The National Patient Register provided diagnoses registered during hospital stays. Agreement was measured with Kappa values (K). RESULTS: agreement between self- and proxy-reports was substantial for diabetes mellitus (K = 0.79), atrial fibrillation (K = 0.61), myocardial infarction (K = 0.75), angina pectoris (K = 0.73) and hypertension (K = 0.62), and fair for intermittent claudication (K = 0.38) and heart failure (K = 0.40). Compared to the National Patient Register, a large proportion of those with a hospital discharge diagnosis were also self- and proxy-reported. CONCLUSIONS: proxy informants can be an important source of information, at least for well-defined conditions such as myocardial infarction, angina pectoris and diabetes mellitus.

Successful Smoking Cessation Associated with Walking Behavior in Patients with Claudication.

BACKGROUND: Behavioral economics theories suggest that a preference for delayed benefits promotes positive behavioral change, a concept relevant to both smoking cessation and community-based exercise regimens for claudication. Given the high rate of smoking among older veterans, we were interested in examining the association between smoking cessation, exercise regimen adherence, and preferences for delayed versus immediate benefits. METHODS: Between April 2017 and March 2018, patients with claudication at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, received questionnaires collecting information on social, behavioral, and psychological characteristics. A dual validation system, via the electronic medical record and survey data, measured the primary outcome-smoking cessation versus current smoking. Self-reported physical activity was measured through the validated Ainsworth's compendium of Physical Activities and binary survey questions. The Walking Impairment and Barratt's Impulsivity Questionnaires measured subjective symptom severity and behavioral economics factors, respectively. Multivariable, logistic regression models identified significant associations. RESULTS: The survey was mailed to 500 patients who met the eligibility criteria. We received responses from 148 individuals (30%), and 67 of 141 (48%) indicated that they had successfully quit smoking. In unadjusted comparisons, the median cognitive complexity score in the smoking cessation group was higher than that in the current smoking group. A greater proportion of patients who reported walking for exercise (n = 46) also reported successful smoking cessation (28/46, 61%). Among those who were not walking for exercise (n = 88), more individuals reported current smoking (49/88, 56%). In the multivariable model, individuals who had successfully stopped smoking were older (odds ratio [OR]: 7.59, P < 0.001), more likely to walk for exercise (OR: 3.94, P = 0.009), more interested in the future than in the present (OR: 1.73, P = 0.030), and more likely to regularly save money (OR: 3.49, P = 0.046). CONCLUSIONS: We found that participants who reported successful smoking cessation were more likely to report walking for exercise. Our findings suggest that adherence to walking may be less challenging for patients who have already successfully implemented and continue to implement another beneficial health behavior (smoking cessation). Patients with claudication who are current smokers may be less likely to adopt exercise recommendations.

Quantification of Daily Physical Activity and Sedentary Behavior of Claudicating Patients.

BACKGROUND: Claudication is the most common manifestation of peripheral artery disease (PAD), producing significant ambulatory compromise. Limited information exists on the routine physical activity of claudicating patients. Our objective was to record the intensity/time profiles of physical activity and the timing and duration of sedentary behavior of a sample of community-dwelling claudicating patients. METHODS: Forty-four claudicating patients referred to our vascular clinic were recruited. Physical activity was recorded using the ActiGraph GT1M activity monitor. The Actigraph monitor is a lightweight instrument designed to measure human movement through changes in acceleration, measured as counts over 1-minute time periods. Data from 7 consecutive days were used for the calculations. We processed the data using the ActiLife software program. RESULTS: The average daily activity of the claudicating patients shows a steady increase beginning approximately 05:30 AM until a peak plateau from approximately 10:00 AM to 01:30 PM followed by a steady decrease until approximately 09:30 PM, when a sustained period of inactivity begins. The average claudicating patient takes 3586 steps per day at an average intensity of 1.77 metabolic equivalents of task (METs, a physiological measure expressing the energy cost of physical activities). Average physical activity intensity and peak intensity fluctuate very little during the day, and they rarely exceed the level of light activity (light = <3 METs maximum effort, such as casual walking or light housework). During awake time, approximately 7 hours are spent in sedentary behaviors (<1.5 METs), and sedentary time is spread throughout the day mostly in short intervals between periods of low-energy activity. CONCLUSIONS: Our study objectively demonstrates the reduced physical activity of claudicating patients and documents physical activity/duration profiles throughout the day. The intensity of the physical activity of the average claudicating patient fluctuates very little during the day and rarely exceeds a light intensity level. Claudicating patients spend approximately half of their awake time in sedentary behavior and when they walk they do it in short bursts followed by several minutes of rest. We anticipate that changes in routine physical activity/duration profiles of patients with PAD will provide relevant, sensitive, and direct measures of the effectiveness of therapeutic interventions.

Are Walking Treatment Beliefs and Illness Perceptions Associated With Walking Intention and 6-Min Walk Distance in People With Intermittent Claudication? A Cross-Sectional Study.

Intermittent claudication is debilitating leg pain affecting older people with peripheral arterial disease, which is improved by regular walking. This study evaluated associations between psychosocial variables and 6-min walk distance (6MWD) to identify factors that motivate walking. A total of 142 individuals with intermittent claudication (116 males; Mage = 66.9 years [SD = 10.2]) completed cross-sectional assessments of sociodemographics, walking treatment beliefs and intention (Theory of Planned Behaviour), illness perceptions (Revised Illness Perceptions Questionnaire), and 6MWD. Multiple linear regression was used to evaluate relationships among psychosocial variables (treatment beliefs and illness perceptions) and outcomes (walking intention and 6MWD). Theory of planned behavior constructs were associated with intention (R = .72, p < .001) and 6MWD (R = .08, p < .001). Illness perceptions were associated with 6MWD only (R = .27, p < .001). Intention (ß = 0.26), treatment control (ß = -0.27), personal control (ß = 0.32), coherence (ß = 0.18), and risk factor attributions (ß = 0.22; all ps < .05) were independently associated with 6MWD. Treatment beliefs and illness perceptions associated with intention and 6MWD in people with intermittent claudication are potential intervention targets.

Identifying content gaps in health status measures for intermittent claudication using the International Classification of Functioning, Disability and Health.

OBJECTIVE: The Walking Impairment Questionnaire (WIQ) and Intermittent Claudication Questionnaire (ICQ) are commonly used patient-reported functional outcome measures for intermittent claudication, but their functional representation has not been characterized. The World Health Organization's International Classification of Functioning, Disability and Health (ICF) framework comprehensively describes health-related function and has been used to evaluate health status and quality of life (QOL) measures. We applied a content analysis technique commonly used in functional rehabilitation research to evaluate ICF domains represented by WIQ and ICQ to characterize their health status and functional representation. METHODS: The overall perspective of each question was assigned as health status-function, health status-disability, Environment-facilitator, Environment-barrier, or QOL. All meaningful concepts in each question were identified and linked to the most appropriate and precise ICF code from the hierarchy of component, chapter, or category using the validated technique. A 20% random sample of questions was secondarily coded with disagreements resolved by discussion. RESULTS: Codability was agreed upon for 87% of questions; agreement was 100% on component and chapter and 88% on category. WIQ contains 18 concepts among 14 questions (1.3 concepts per question); all questions are from the health status-disability perspective. All WIQ concepts are from the "Activities/Participation-d" ICF component, "Mobility-d4" chapter. "Walking long distances" (d4501, >1 km) is omitted. ICQ contains 37 codable concepts among 16 questions (2.3 concepts per question). Thirteen questions are from health status-disability perspective, three from QOL. Sox of the nine chapters of the "Activities/Participation-d" ICF component are represented by 20 of 37 concepts; 11 of 20 in the "Mobility-d4" chapter. The other "Activities/Participation-d" chapters and categories in ICQ are "Learning/applying knowledge" ("thinking-d163"), "General tasks/demands" ("carrying out daily routine-d230"), "Domestic life" ("shopping-d6200," "doing housework-d640"), "Major life areas" ("Maintaining a job-d8451"), and "Community life" ("socializing-d9205," "hobbies-d9204"). "Body Functions-b" ICF component is represented 11 times, covering pain, numbness, emotion, mood, and cardiovascular functions. "Body Structures-s" is represented three times as lower extremity. Neither WIQ nor ICQ specifically addresses "Walking on different surfaces," (64,502) "Walking around obstacles" (d4503), or "Moving around using equipment" (d465), which includes assistive devices. Walking on an incline is not addressed in WIQ, ICQ, or the ICF. CONCLUSIONS: Applying this ICF-based content assessment methodology to patient-reported vascular disease outcome measures is feasible, representing a novel method of assessing such instruments. WIQ's scope is limited; it does not address functional capacity and covers only health status pertaining to walking disability. The ICQ is more inclusive, but concept density may obscure meaning. Neither instrument is functionally comprehensive and both have significant omissions that should be considered for inclusion.

Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication.

BACKGROUND: Although supervised exercise therapy (SET) provides significant symptomatic benefit for patients with intermittent claudication (IC), it remains an underutilized tool. Widespread implementation of SET is restricted by lack of facilities and funding. Structured home-based exercise therapy (HBET) with an observation component (e.g., exercise logbooks, pedometers) and just walking advice (WA) are alternatives to SET. This is the second update of a review first published in 2006. OBJECTIVES: The primary objective was to provide an accurate overview of studies evaluating effects of SET programs, HBET programs, and WA on maximal treadmill walking distance or time (MWD/T) for patients with IC. Secondary objectives were to evaluate effects of SET, HBET, and WA on pain-free treadmill walking distance or time (PFWD/T), quality of life, and self-reported functional impairment. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (December 16, 2016) and the Cochrane Central Register of Controlled Trials (2016, Issue 11). We searched the reference lists of relevant studies identified through searches for other potential trials. We applied no restriction on language of publication. SELECTION CRITERIA: We included parallel-group randomized controlled trials comparing SET programs with HBET programs and WA in participants with IC. We excluded studies in which control groups did not receive exercise or walking advice (maintained normal physical activity). We also excluded studies comparing exercise with percutaneous transluminal angioplasty, bypass surgery, or drug therapy. DATA COLLECTION AND ANALYSIS: Three review authors (DH, HF, and LG) independently selected trials, extracted data, and assessed trials for risk of bias. Two other review authors (MvdH and JT) confirmed the suitability and methodological quality of trials. For all continuous outcomes, we extracted the number of participants, mean outcome, and standard deviation for each treatment group through the follow-up period, if available. We extracted Medical Outcomes Study Short Form 36 outcomes to assess quality of life, and Walking Impairment Questionnaire outcomes to assess self-reported functional impairment. As investigators used different scales to present results of walking distance and time, we standardized reported data to effect sizes to enable calculation of an overall standardized mean difference (SMD). We obtained summary estimates for all outcome measures using a random-effects model. We assessed the quality of evidence using the GRADE approach. MAIN RESULTS: For this update, we included seven additional studies, making a total of 21 included studies, which involved a total of 1400 participants: 635 received SET, 320 received HBET, and 445 received WA. In general, SET and HBET programs consisted of three exercise sessions per week. Follow-up ranged from six weeks to two years. Most trials used a treadmill walking test to investigate effects of exercise therapy on walking capacity. However, two trials assessed only quality of life, functional impairment, and/or walking behavior (i.e., daily steps measured by pedometer). The overall methodological quality of included trials was moderate to good. However, some trials were small with respect to numbers of participants, ranging from 20 to 304.SET groups showed clear improvement in MWD/T compared with HBET and WA groups, with overall SMDs at three months of 0.37 (95% confidence interval [CI] 0.12 to 0.62; P = 0.004; moderate-quality evidence) and 0.80 (95% CI 0.53 to 1.07; P < 0.00001; high-quality evidence), respectively. This translates to differences in increased MWD of approximately 120 and 210 meters in favor of SET groups. Data show improvements for up to six and 12 months, respectively. The HBET group did not show improvement in MWD/T compared with the WA group (SMD 0.30, 95% CI -0.45 to 1.05; P = 0.43; moderate-quality evidence).Compared with HBET, SET was more beneficial for PFWD/T but had no effect on quality of life parameters nor on self-reported functional impairment. Compared with WA, SET was more beneficial for PFWD/T and self-reported functional impairment, as well as for some quality of life parameters (e.g., physical functioning, pain, and physical component summary after 12 months), and HBET had no effect.Data show no obvious effects on mortality rates. Thirteen of the 1400 participants died, but no deaths were related to exercise therapy. Overall, adherence to SET was approximately 80%, which was similar to that reported with HBET. Only limited adherence data were available for WA groups. AUTHORS' CONCLUSIONS: Evidence of moderate and high quality shows that SET provides an important benefit for treadmill-measured walking distance (MWD and PFWD) compared with HBET and WA, respectively. Although its clinical relevance has not been definitively demonstrated, this benefit translates to increased MWD of 120 and 210 meters after three months in SET groups. These increased walking distances are likely to have a positive impact on the lives of patients with IC. Data provide no clear evidence of a difference between HBET and WA. Trials show no clear differences in quality of life parameters nor in self-reported functional impairment between SET and HBET. However, evidence is of low and very low quality, respectively. Investigators detected some improvements in quality of life favoring SET over WA, but analyses were limited by small numbers of studies and participants. Future studies should focus on disease-specific quality of life and other functional outcomes, such as walking behavior and physical activity, as well as on long-term follow-up.

Translation and Validation of the Brazilian-Portuguese Short Version of Vascular Quality of Life Questionnaire in Peripheral Artery Disease Patients with Intermittent Claudication Symptoms.

BACKGROUND: The Vascular Quality of Life Questionnaire (VascuQoL-6) was proposed to evaluate specific quality of life of peripheral artery disease (PAD) patients. However, there is no Brazilian-Portuguese version available, blunting its use in Brazilian patients. The objective of the study was to analyze the psychometric properties of a translated Brazilian-Portuguese version of VascuQoL-6 in Brazilian patients with PAD with intermittent claudication symptoms. METHODS: One hundred eleven patients with PAD participated in the study. After translation and retranslation, construct validity was analyzed by identifying correlation between VascuQoL-6 scores, general World Health Organization qualify of life (WHOQOL) score, and subjective and objective functional capacity tests. To determine the reliability, internal consistency and test-retest reliability with at least 7 days interval between 2 questionnaire applications were calculated. RESULTS: Significant correlations between the VascuQoL-6 score and total WHOQOL score (r = 0.44; P < 0.05) were observed. Moreover, we observed negative correlations between the VascuQoL-6 score and 4-meter usual pace (r = -0.33; P < 0.05) and 4-meter fast pace (r = -0.34; P < 0.05) and positive correlation with onset claudication distance (r = 0.39; P < 0.05) and total walking distance (r = 0.29; P ≤ 0.05). Internal consistency was 0.84, whereas the intraclass coefficient correlation was 0.84, with no differences in VascuQoL-6 scores between the 2 applications days. CONCLUSIONS: The Brazilian-Portuguese version of the VascuQoL-6 presents adequate valid and reliability indicators, allowing its use in patients with PAD with intermittent claudication symptoms.

User Preferences for Mobile Health Interventions: A Survey among Intermittent Claudication Patients and Their Physical Therapists.

BACKGROUND: Smartphone apps provide novel ways for triggering lifestyle change by coupling objective measurements of health behavior with tailored feedback. Little is known about end-user preferences regarding the content of mobile health (mHealth) interventions. The aim of this study was to assess smartphone use and preferences regarding app content among intermittent claudication patients and their treating physical therapists. METHODS: A cross-sectional survey was sent via an internal email system to 1,514 physical therapists specialized in treating patients with intermittent claudication. They were asked to complete one questionnaire themselves and administer a second to their intermittent claudication patients currently under treatment. Data on participant characteristics and smartphone use were collected from all respondents. The preferred app components were obtained from participants owning a smartphone. Binary logistic regression analysis was used to explore the adjusted association between age and attained educational level, and smartphone use. RESULTS: The response rate of therapists was 40.8% (617/1,514), and a total of 488 patients completed the survey. After excluding incomplete forms, a total of 615 physical therapist forms and 483 patient forms were analyzed. Overall, 40.6% of patients and 95% of therapists owned a smartphone. Higher educational level was associated with smartphone ownership (adjusted odds ratio = 2.46, 95% confidence interval (CI) = 1.41-4.27, P = 0.001). Compared to patients aged ≥75 years, lower age was associated with higher odds of owning a smartphone (adjusted odds ratios for patients aged ≤54 years = 21.27, 95% CI = 6.82-66.30, P < 0.001; aged 55-64 years = 4.76, 95% CI = 2.52-9.00, P < 0.001; and aged 65-74 years = 2.58, 95% CI = 1.54-4.33, P < 0.001). The most preferred app components for intermittent claudication patients in possession of a smartphone included monitoring treadmill-measured walking distances (71%), global positioning system tracking of walks (50%), and daily physical activity monitoring (49%). Physical therapists were most interested in global positioning system tracking of walks (89%), daily physical activity monitoring (82%), keeping track of treadmill-measured walking distance (79%), help with smoking cessation (65%). CONCLUSIONS: Smartphone ownership is associated with younger age and a higher educational level in patients with intermittent claudication. This study provides a framework of end-user preferences regarding desired features to guide the development of an app to potentiate health outcomes of intermittent claudication treatment.

Exploring physical activity behaviour - needs for and interest in a technology-delivered, home-based exercise programme among patients with intermittent claudication.

BACKGROUND: Supervised walking is a first line therapy in peripheral arterial disease (PAD) with complaints of intermittent claudication. However, uptake of supervised programmes is low. Home-based exercise seems an appealing alternative; especially since technological advances, such as tele-coaching and tele-monitoring, may facilitate the process and support patients when adopting a physically active lifestyle. To guide the development of such an intervention, it is important to identify barriers of physical activity and the needs and interests for technology-enabled exercise in this patient group. PATIENTS AND METHODS: PAD patients were recruited at the vascular centre of UZ Leuven (Belgium). A questionnaire assessing PA (SF-International Physical Activity Questionnaire), barriers to PA, and interest in technology-supported exercise (Technology Usage Questionnaire) was completed. Descriptive and correlation analyses were performed. RESULTS: Ninety-nine patients (76 men; mean age 69 years) completed the survey. Physical activity levels were low in 48 %, moderate in 29 %, and high in 23 %. Intermittent claudication itself is the most important barrier for enhanced PA, with most patients reporting pain (93 %), need for rest (92 %), and obstacles worsening their pain (74 %) as barriers. A total of 93 % participants owned a mobile phone; 76 % had Internet access. Eighty-seven reported the need for an exercise programme, with 67 % showing interest in tele-coaching to support exercise. If technology was available, three-quarter stated they would be interested in home-based tele-coaching using the Internet (preferably e-mails, 86 %); 50 % via mobile phone, 87 % preferred text messages. Both were inversely related to age (rpb = 0.363 and rpb = 0.255, p < 0.05). Acquaintance with elastic bands or gaming platforms was moderate (55 and 49 %, respectively), but patients were interested in using them as alternatives (84 and 42 %). Interest in platforms was age-dependent (rs = -0.508, p < 0.01). CONCLUSIONS: PAD patients show significant interest in technology-delivered exercise, offering opportunities to develop a guided home-based exercise programme.

Revascularization of smokers with claudication is not predicted to limit quality of life despite a higher risk of late failure.

OBJECTIVE: Tobacco smoking after lower extremity revascularization for claudication has repeatedly been shown to increase the risk of adverse events, such that many vascular specialists consider that refusal to abstain from smoking constitutes a major contraindication to open surgical bypass or endovascular intervention. METHODS: A Markov decision analysis (DA) model was used to compare the options of direct revascularization vs medical therapy only in smokers with claudication. The primary outcome was calculated quality of life (cQoL), determined for each patient at follow-up based on the outcomes of the treatment received. Markov DA software was used to predict the QoL for each treatment option preoperatively based on smoking status. RESULTS: Among patients referred during a recent 64-month period with vasculogenic claudication, 94 were actively smoking compared with 217 who were not. The DA model predicted that if the patients who smoked were to discontinue smoking, the best therapy would be bypass surgery for 77% and endovascular intervention for 17%. However, despite at least doubling the risks with intervention in the patients who continue to smoke, the DA model still predicted that 78% and 9% would fare better with open surgical or endovascular intervention, respectively. Among actively smoking patients, open surgical (3%) or endovascular (4%) therapies were initially performed in few patients, whereas 93% were offered only medical therapy. Among initial nonsmokers, revascularization was performed by open (27%) or endovascular (42%) means. At 3 years, the median (interquartile range [IQR]) cQoL was lower in initial smokers than in nonsmokers (0.73 [IQR, 0.73-0.77] vs 0.82 [IQR, 0.75-0.86]; P < .0001), primarily because of a lack of revascularization for smokers. Among initial smokers who did undergo revascularization initially, because of progression of symptoms, or after smoking cessation, cQoL was similar to initial nonsmokers (0.77 [IQR, 0.73-0.84] vs 0.73 [IQR, 0.73-0.73]; P = .37). Although 26% of initial smokers had stopped by the time of their last follow-up, 10% of initially nonsmoking patients were smoking at follow-up. However, among all patients undergoing intervention, the cQoL of patients smoking at the time of last their follow-up was similar to nonsmokers (0.82 [IQR, 0.82-0.86] vs 0.83 [IQR, 0.73-0.86]; P = .99). CONCLUSIONS: Patients with claudication who smoke may be denied the symptom improvement associated with revascularization, yet recidivism for smoking also occurs among patients who have stopped smoking in order to receive revascularization. The strategy not to directly revascularize patients with claudication who continue to smoke does not appear to maximize patient midterm QoL.

The Effect of Structured Patient Education on Physical Activity in Patients with Peripheral Arterial Disease and Intermittent Claudication: A Systematic Review.

OBJECTIVES: The aim was review the components and effects of patient education interventions to improve physical activity (PA) in patients with peripheral arterial disease (PAD) and intermittent claudication (IC), and patients' experiences of these interventions. DATA SOURCES: CINAHL, Cochrane Library, Ovid, ProQuest, AMED, MEDLINE, PsycINFO, Web of Science Core Collection, and PEDRO, and Trial registers and directory of Open Access repository websites and Web of science conference proceedings were searched. Hand searching of reference lists of identified studies was also performed to identify studies that reported the effect of patient education interventions on daily PA and/or walking capacity in individuals with PAD and IC, or studies investigating patients' experiences of such interventions. METHODS: A systematic search was conducted in June 2016 (updated in March 2017). Primary outcomes were daily step count and self reported PA; the secondary outcome was absolute claudication distance. There was substantial heterogeneity in terms of modalities of patient education in the included studies; hence a narrative synthesis was implemented. RESULTS: Six studies (1087 participants) were included in the review. Findings from a small number of high quality trials demonstrated potential for PA improvement with structured education interventions. Nevertheless, evidence is currently inconclusive regarding the effect on daily PA and walking capacity of patients with IC. Patients reported that they valued the interventions studied, finding them acceptable and important in improving their PA, motivating and empowering them to self manage their condition. CONCLUSIONS: The evidence from the review is limited and inconclusive regarding the effectiveness of structured education for increasing PA in patients with PAD and IC. More rigorous trials are needed before recommendations can be made. Future interventions should consider the key criteria for a structured patient education programme, and also report patients' experiences and perceptions.

Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance: 12 Month Results of a Controlled Randomised Multicentre Trial.

BACKGROUND: Invasive treatment of intermittent claudication (IC) because of severe atherosclerotic stenosis or occlusion in the superficial femoral artery (SFA) is controversial. This prospective randomised trial was performed to assess the impact on health related quality of life (HRQoL) of primary stenting with nitinol self expanding stents compared with best medical treatment alone in patients suffering from stable IC due to SFA disease. METHODS: One hundred patients with stable IC caused by SFA disease from seven Swedish hospitals treated with best medical treatment (BMT) were randomised to either the stent (n = 48) or the control (n = 52) group. Change in HRQoL assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 12 months after treatment was the primary outcome measure. Improvement in the Walking Impairment Questionnaire (WIQ), ankle brachial index (ABI), and walking distance were secondary outcomes. RESULTS: HRQoL improved significantly. In the stent group the following SF-36 domains improved: Physical Function, 19 points (p < .001); Bodily Pain, 14 points (p = .001); General Health, 6 points (p = .019); Vitality, 10 points (p = .004); Physical Component Summary, 6.5 points (p < .001); EQ5D, 0.14 points (p = .008); and WIQ 22 points (p < .001). They were unchanged in the control group. Both ABI (from 0.58 ± 0.11 to 0.86 ± 0.19, p < .001, in the stent group and from 0.63 ± 0.17 to 0.70 ± 0.20, p = .005, in the control group) and walking distance (WD) (from 171 ± 90 meters to 613 ± 381 meters, p < .001, in the stent group and from 209 ± 106 m to 335 ± 321 meters, p = .012, in the control group) improved, and at 12 months both the ABI (p < .001) and the WD (p = .001) were higher in the stent group. CONCLUSIONS: In patients with IC caused by lesions in the SFA, the addition of primary stenting to BMT was associated with significant improvement in HRQoL, ABI, and walking distance after 12 months follow-up compared with BMT alone.

Clinimetric Evaluation of the Vascular Quality of Life Questionnaire in Patients with Lower Limb Ischaemia.

OBJECTIVES: Although commonly used to measure health related quality of life in patients with lower limb ischaemia, the measurement properties of the VascuQol and its assumed underlying health dimensions have not been studied in depth. The objective of this study was therefore to evaluate aspects of reliability and validity of the Dutch version of the VascuQol in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). METHODS: Two datasets containing 195 patients with IC and 150 patients with CLI were used. Face validity of the VascuQol was examined in interviews with patients and a survey among health professionals. Homogeneity and structural validity of the VascuQol were assessed using Cronbach's α coefficients and explanatory factor analysis. Furthermore, convergent validity and known group validity were assessed. RESULTS: During the face validity interviews, three items were indicated as less relevant. Homogeneity analysis showed that the α coefficient of the VascuQol was .93, while the symptoms and social domains had α coefficients below the threshold of .70. The original five domains of the VascuQol could not be reproduced. Instead, factor analysis yielded a three factor solution. Moderate correlations were found for the activities, social and emotional VascuQol domains and matching health domains of other patient reported outcome measures (PROMs). Lower convergent correlations were observed for the pain domain and the sumscore of the VascuQol. The VascuQol was able to distinguish between patients' level of HRQL in relation to their disease severity (IC versus CLI patients). CONCLUSIONS: There is room for improvement of the VascuQol questionnaire. Further clinimetric studies should be performed to strengthen clinically relevant findings based on this instrument.