Participants' experiences and acceptability of a home-based walking exercise behaviour-change intervention (MOtivating Structure walking Activity in people with Intermittent Claudication (MOSAIC)).

OBJECTIVES: This study explored the experiences and acceptability of a novel, home-based, walking exercise behaviour-change intervention (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in adults with Peripheral Arterial Disease (PAD). DESIGN AND SETTING: Individual semi-structured audio-recorded interviews were conducted with adults with Peripheral Arterial Disease who had completed the MOSAIC intervention as part of a randomised clinical trial. Data were analysed using inductive reflexive thematic analysis and interpreted using the seven-construct theoretical framework of acceptability of healthcare interventions (TFA). PARTICIPANTS: Twenty participants (mean age (range) 67(54-80) years, 70% male, 55% White British) were interviewed. RESULTS: One central theme was identified: Acceptability of walking exercise as a treatment. This theme was explained by four linked themes: Exploring walking exercise with a knowledgeable professional, Building confidence with each step, Towards self-management-learning strategies to continue walking and The impact of walking exercise. These themes were interpreted using six of the seven TFA constructs: affective attitude, burden, perceived effectiveness, intervention coherence, opportunity costs, and self-efficacy. CONCLUSIONS: Participants perceived MOSAIC as an effective, acceptable, and low burden intervention. Physiotherapists were regarded as knowledgeable and supportive professionals who helped participants understand PAD and walking exercise as a treatment. Participants developed confidence to self-manage their condition and their symptoms. As participants confidence and walking capacity improved, they expanded their activities and gained a more positive outlook on their future. MOSAIC is an acceptable intervention that may facilitate adoption of and access to exercise for people with PAD.

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.

Cilostazol improves the quality of life and lower-limb functional capacity also in diabetic patients / A cilostazol diabeteses betegekben is javítja az életminoséget és az alsó végtagi funkcionális kapacitást.

INTRODUCTION: Intermittent claudication has a significant negative impact on the patients' quality of life. Revascularization procedures and noninvasive medical therapies can improve walking capacity. Cilostazol has IA recommendation for the treatment of intermittent claudication. AIM: The aim of this study was to evaluate the effect of a three-month cilostazol treatment on the health-related quality of life and on the lower-limb functional capacity in diabetic (DM) and non-diabetic patients (NDM) with intermittent claudication in the clinical practice. METHOD: The study was a multicenter, non-interventional trial; 812 patients with peripheral artery disease (Fontaine II stage, mean age: 67.17 years, male/female: 58.25/41.75%, 318 diabetics) were enrolled, who received cilostazol (50 or 100 mg twice a day) for 3 months. The quality of life was evaluated with the EQ-5D-3L questionnaire, the functional capacity with the WELCH questionnaire. Walking distances, ankle-brachial index were measured at baseline and after 3 months. RESULTS: Upon conclusion of the study, the EQ-5D index improved both in non-diabetic and diabetic patients (baseline: NDM -0.45 ± 0.22, DM -0.48 ± 0.23, 3rd month: -0,24 ± 0.18, -0,27 ± 0.19; respectively; p<0.0001) and there was a significant increase in the WELCH score as well (baseline: NDM 20 ± 14, DM 18 ± 14; 3rd month: 33 ± 19, 29 ± 16, respectively; p<0.0001). Both pain-free and maximal walking distance increased by 59.2% (median: 50.0%), 46.58 (median: 40.51%) in NDM and 42.85% (median: 43.33%), 41.61% (median: 34.68%) in DM patients, respectively (p<0.001). CONCLUSIONS: Three months of cilostazol treatment improved the quality of life and lower-limb functional capacity in diabetic and non-diabetic claudicant patients. The WELCH questionnaire is a useful tool in clinical practice for the evaluation of intermittent claudication treatment. Orv Hetil. 2020; 161(38): 1637-1645.

Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication.

BACKGROUND: Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial. METHODS/DESIGN: BOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol. DISCUSSION: The planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report. TRIAL REGISTRATION: This study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674 . Registered on 10 November 2015.

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.

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.

Assessment of behavioral determinants influencing success of supervised exercise therapy in patients with intermittent claudication: A cross sectional survey.

BACKGROUND: Supervised exercise therapy is the first step in treatment of intermittent claudication. However, adherence to supervised exercise therapy is low. Limited access and reimbursement issues are known reasons, though lack of motivation is often leading. Behavioral determinants influencing motivation and thus adherence to supervised exercise therapy remain to be investigated. In this study we sought to determine which behavioral determinants would be of influence on the long-term adherence of supervised exercise therapy. METHODS: 200 patients, newly diagnosed with peripheral arterial disease Rutherford classification II-III, were sent a questionnaire to assess motivation and behavior with regard to supervised exercise therapy. The questionnaire was constructed using the I-CHANGE model for explaining motivational and behavioral change. Baseline characteristics were acquired from medical records. Alpha Cronbach's was calculated to test reliability of the questionnaire. RESULTS: 108 (54%) patients returned their questionnaire. A total of 79% patients followed supervised exercise therapy. Patients who increased their walking distance after supervised exercise therapy have significantly greater knowledge (p = 0.05), positive attitude (p = 0.03) and lower negative attitude (p = 0.01). Patients with a higher self-efficacy remained significantly more active after participating in supervised exercise therapy (p = 0.05). CONCLUSION: Increasing the determinants knowledge, attitude and self-efficacy will improve adherence to supervised exercise therapy and result in delayed claudication onset time.

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.

Motivating Structured walking Activity in people with Intermittent Claudication (MOSAIC): protocol for a randomised controlled trial of a physiotherapist-led, behavioural change intervention versus usual care in adults with intermittent claudication.

INTRODUCTION: Walking exercise is a recommended but underused treatment for intermittent claudication caused by peripheral arterial disease (PAD). Addressing the factors that influence walking exercise may increase patient uptake of and adherence to recommended walking. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of a physiotherapist-led behavioural change intervention on walking ability in adults with intermittent claudication (MOtivating Structured walking Activity in people with Intermittent Claudication (MOSAIC)) in comparison with usual care. METHODS AND ANALYSIS: The MOSAIC trial is a two-arm, parallel-group, single-blind RCT. 192 adults will be recruited from six National Health Service Hospital Trusts. Inclusion criteria are: aged ≥50 years, PAD (Ankle Brachial Pressure Index ≤0.90, radiographic evidence or clinician report) and intermittent claudication (San Diego Claudication Questionnaire), being able and willing to participate and provide informed consent. The primary outcome is walking ability (6 min walking distance) at 3 months. Outcomes will be obtained at baseline, 3 and 6 months by an assessor blind to group allocation. Participants will be individually randomised (n=96/group, stratified by centre) to receive either MOSAIC or usual care by an independent randomisation service. Estimates of treatment effects will use an intention-to-treat framework implemented using multiple regression adjusted for baseline values and centre. ETHICS AND DISSEMINATION: This trial has full ethical approval (London-Bloomsbury Research Ethics Committee (17/LO/0568)). It will be disseminated via patient forums, peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN14501418.

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.

Development and delivery of the BOOST (Better Outcomes for Older adults with Spinal Trouble) intervention for older adults with neurogenic claudication.

Neurogenic claudication due to spinal stenosis is a common cause of disability in older adults. Conservative treatments are a favourable treatment option. This paper describes the development and delivery of the BOOST (Better Outcomes for Older adults with Spinal Trouble) intervention, a physiotherapist-delivered physical and psychological intervention for the management of neurogenic claudication in older adults. The BOOST intervention is being tested in a multi-centre, randomised controlled trial in UK National Health Service Trusts; delivered by physiotherapists registered with the Health and Care Professionals Council. Participants are aged 65 years or older, registered with a primary care practice, and report symptoms consistent with neurogenic claudication. Intervention content and delivery was initially informed by clinical and patient experts, research evidence, and behaviour change guidelines; and refined following an intervention development day attended by researchers, health professionals, and Patient and Public Involvement representatives. The BOOST intervention comprises 12 group sessions, promoting sustained adherence with a long term home and physical activity programme. Each session includes education and group discussion, individually tailored exercises, and walking. Initial exercise levels are set at a one-to-one assessment. Continued home exercise adherence and increased physical activity following completion of the sessions is facilitated through support telephone calls. Trial registration ISRCTN12698674.

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.

Clinical and linguistic validation of the Polish version of VascuQol: a disease-specific quality-of-life questionnaire assessing patients with chronic limb ischemia

INTRODUCTION Objective clinical assessments should include patient­reported outcome measures. VascuQol is an established disease­specific questionnaire assessing the quality of life in patients with peripheral artery disease (PAD). Quality­of­life questionnaires require geographical localization and validation. OBJECTIVES The goal of this study was to validate the Polish version of the VascuQol: a patient­reported health­related quality­of­life (HRQoL) instrument specific for PAD. PATIENTS AND METHODS The linguistic validation of VascuQol followed Mapi Institute methodology. Clinical validation process compared VascuQol, EQ­5D­3L, and SF­36 questionnaires in 100 patients with both intermittent claudication and critical limb­threatening ischemia. Cronbach α coefficients for reliability, receiver operating characteristic curves for clinical discriminative performance, standardized response means for responsiveness, and Pearson correlations for construct validity were evaluated. Additionally, in a separate cohort of 58 patients with stable disease, the test­retest was characterized with intraclass correlation, Bland­Altman analysis, and Pearson correlation coefficients. RESULTS VascuQol proved to perform better than SF­36 and EQ­5D­3L. Cronbach α coefficients showed good internal consistency (α values >0.9 for all summary scores). All test­retest Pearson r values for VascuQol were above 0.70. The intraclass correlation of absolute agreement consistency exceeded 0.8. The Bland­Altman 95% limits of agreement were between 2.72 and 4.87. There were strong and moderate correlations for total scores in all domains between VascuQol and SF­36, and for most of the domains between VascuQol and EQ­5D­3L. CONCLUSIONS The Polish version of VascuQol is a sensitive, accurate, and reliable tool for assessing HRQoL in patients with PAD.

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.

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.

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.

The role of psychopathology in perceiving, reporting and treating intermittent claudication: a systematic review.

INTRODUCTION: The aim of this systematic review is to investigate the association between mental health and intermittent claudication (IC) perception, reporting and treatment in subjects with peripheral artery disease (PAD). EVIDENCE ACQUISITION: Literature searches of experimental and observational studies published until February 1st, 2016 were conducted using the following electronic databases: Medline/PubMed and Embase. The selection criteria for the studies included a population of patients diagnosed with peripheral artery disease who reported symptoms of intermittent claudication and were assessed for any psychopathological states (depression, anxiety, mood and personality disorders), which in turn were analyzed with regard to the following: IC severity, symptom perception and reporting, patients' quality of life, treatment compliance and its effectiveness. The risk of bias was assessed using Cochrane Collaboration's tool and the Newcastle Ottawa Scales. The strength of recommendations was graded according to GRADE system. EVIDENCE SYNTHESIS: The literature search identified 1598 citations, of which 13 studies with varying risk of bias were included in the review. Depression, anxiety, and personality types were described in more than 800 patients with peripheral arterial disease who suffered from intermittent claudication. With regard to IC perception and reporting, individuals with higher levels of depression had lower levels of pain acceptance, were more dissatisfied with their function and control over function and had a poorer quality of life. In the case of the type D personality, the results were not consistent. Studies assessing the influence of psychopathology on IC severity and treatment also showed discrepant results. Some studies indicated no differences between type D and non-type D patients with regard to the Ankle Brachial Index as well as pain free (PFWD) and maximal walking distances (MWD). On the other hand, others revealed that type D and depressed patients terminated 6MWT prematurely due to the onset of symptoms and experienced a greater annual decline in 6-minute walk distance, fast walking velocity and short physical performance battery. With regard to treatment adherence, patients with no mental problems made the best recoveries. Hostility, aggressiveness and affect-liability were the greatest obstacles to compliance. CONCLUSIONS: Mental disorders might influence the way in which the symptoms of the disease are reported, coped with, and treated. However, the results of the review preclude recommending a routine psychological examination as one of basic diagnostic procedures in patients with peripheral artery disease suffering from IC.

Barriers and enablers to walking in individuals with intermittent claudication: A systematic review to conceptualize a relevant and patient-centered program.

BACKGROUND: Walking limitation in patients with peripheral arterial disease (PAD) and intermittent claudication (IC) contributes to poorer disease outcomes. Identifying and examining barriers to walking may be an important step in developing a comprehensive patient-centered self-management intervention to promote walking in this population. AIM: To systematically review the literature regarding barriers and enablers to walking exercise in individuals with IC. METHODS: A systematic review was conducted utilizing integrative review methodology. Five electronic databases and the reference lists of relevant studies were searched. Findings were categorized into personal, walking activity related, and environmental barriers and enablers using a social cognitive framework. RESULTS: Eighteen studies including quantitative (n = 12), qualitative (n = 5), and mixed method (n = 1) designs, and reporting data from a total of 4376 patients with IC, were included in the review. The most frequently reported barriers to engaging in walking were comorbid health concerns, walking induced pain, lack of knowledge (e.g. about the disease pathology and walking recommendations), and poor walking capacity. The most frequently reported enablers were cognitive coping strategies, good support systems, and receiving specific instructions to walk. Findings suggest additionally that wider behavioral and environmental obstacles should be addressed in a patient-centered self-management intervention. CONCLUSIONS: This review has identified multidimensional factors influencing walking in patients with IC. Within the social cognitive framework, these factors fall within patient level factors (e.g. comorbid health concerns), walking related factors (e.g. claudication pain), and environmental factors (e.g. support systems). These factors are worth considering when developing self-management interventions to increase walking in patients with IC. Systematic review registration CRD42018070418.

Comparison of EQ-5D and SF-36 in untreated patients with symptoms of intermittent claudication.

AIM: To compare health-related quality of life (HRQoL) descriptions and utility scores in newly diagnosed peripheral arterial disease (PAD) patients, using two most widely used instruments, EuroQol 5D (EQ-5D) and Medical Outcome Study 36-item Short-Form Health Status Survey (SF-36). METHODS: Patients' self-assessment of HRQoL was measured by the Dutch versions of the EQ-5D and SF-36 in the 204 patients. RESULTS: Mean utility scores ranged from 0.675 for Short-Form Six-Dimension, 0.648 for the EQ-5D UK tariff and 0.715 for the Dutch EQ-5D tariff. A moderate correlation between the utility scores was found due to different valuation techniques of these instruments. CONCLUSION: Both instruments have clinical validity for use in the PAD and can be used alongside each other to provide a holistic assessment of the HRQoL. Before using these two instruments interchangeably for utility score calculations and healthcare resource allocation, a thorough sensitivity analysis is necessary to explore the robustness of the value argument based on these utility scores.

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.