Reliability and validity of self-report questions for assessing levels of physical activity and sedentary time in adult childhood cancer survivors.

BACKGROUND: Regular physical activity and limited sedentary time are recommended for adult childhood cancer survivors. The Swedish National Board of Health and Welfare designed a questionnaire to assess levels of physical activity (BHW-Q), including two questions: one on vigorous physical activity (BHW-Q VPA) and one on moderate physical activity (BHW-Q MPA). Furthermore, a single-item question was developed to measure sedentary time (SED-GIH-Q). These questions are recommended for clinical practice and have been found valid for the general population but have so far not been tested in adult childhood cancer survivors. The aim of the study was to assess test-retest reliability, agreement and criterion-related validity of the BHW-Q and the SED-GIH-Q in adult childhood cancer survivors. METHOD: A non-experimental methodological study. In total 60 participants (50% women), median age 28 (min-max 18-54) years were included at the Long-Term Follow-Up Clinic at Sahlgrenska University Hospital. Participants were instructed to wear an accelerometer for seven days, and to answer the BHW-Q and the SED-GIH-Q before and after the seven days. Test-retest reliability and criterion-related validity comparing the BHW-Q and SED GIH-Q with accelerometer data were calculated with weighted Kappa (k) (agreement) and by using Spearman´s rho (r) (correlation). RESULTS: Test-retest reliability regarding the SED-GIH-Q showed a high agreement (k = 0.88) and very strong correlation (r = 0.93), while the BHW-Q showed a moderate agreement and moderately strong correlation, BHW-Q VPA (k = 0.50, r = 0.64), BHW-Q MPA (k = 0.47, r = 0.58). Both the agreement and the correlation of the criterion-related validity were interpreted as fair for the BHW-Q VPA (k = 0.29, r = 0.45), while the agreement for BHW-Q MPA was interpreted as low (k = 0.07), but the correlation as fair (r = 0.37). The agreement of the SED-GIH-Q (k = 0.13) was interpreted as low and the correlation as poor (r = 0.26). CONCLUSION: These simple questions assessing physical activity and sedentary time can be used as screening tools in clinical practice to identify adult childhood cancer survivors in need of support to increase physical activity level. Further development is needed on the design of a sufficiently valid question measuring sedentary time. TRIAL REGISTRATION: This research project was registered in the Swedish National Database of Research and Development; identifier 275251, November 25, 2020. https://www.researchweb.org/is/vgr/project/275251 .

Cardiovascular disease as part of Long COVID: A systematic review.

BACKGROUND: Long COVID syndrome has had a major impact on million patients' lives worldwide. The cardiovascular system is an important aspect of this multifaceted disease that may manifest in many ways. We have hereby performed a narrative review in order to identify the extent of the cardiovascular manifestations of the Long COVID syndrome. METHODS AND RESULTS: An in-depth systematic search of the literature has been conducted for this narrative review. The systematic search of PubMed and Cochrane databases yielded 3,993, of which 629 underwent full text screening. A total of 78 studies were included in the final qualitative synthesis and data evaluation. The pathophysiology of the cardiovascular sequelae of Long COVID syndrome and the cardiac manifestations and complications of Long COVID syndrome are critically evaluated. In addition, potential cardiovascular risk factors are assessed, and preventive methods and treatment options are examined in this review. CONCLUSIONS: This systematic review poignantly summarises the evidence from the available literature regarding the cardiovascular manifestations of Long COVID syndrome and reviews potential mechanistic pathways, diagnostic approaches, preventive measures and treatment options.

Usability and feasibility analysis of an mHealth-tool for supporting physical activity in people with heart failure.

BACKGROUND: Physical inactivity and a sedentary lifestyle are common among people with heart failure (HF), which may lead to worse prognosis. On an already existing mHealth platform, we developed a novel tool called the Activity coach, aimed at increasing physical activity. The aim of this study was to evaluate the usability of the Activity coach and assess feasibility of outcome measures for a future efficacy trial. METHODS: A mixed-methods design was used to collect data. People with a HF diagnosis were recruited to use the Activity coach for four weeks. The Activity coach educates the user about physical activity, provides means of registering daily physical activity and helps the user to set goals for the next week. The usability was assessed by analysing system user logs for adherence, reported technical issues and by interviews about user experiences. Outcome measures assessed for feasibility were objective physical activity as measured by an accelerometer, and subjective goal attainment. Progression criteria for the usability assessment and for the proposed outcomes, were described prospectively. RESULTS: Ten people with HF were recruited, aged 56 to 78 with median age 72. Data from nine of the ten study participants were included in the analyses. Usability: The Activity coach was used 61% of the time and during the first week two study participants called to seek technical support. The Activity coach was found to be intuitive and easy to use by all study participants. An increased motivation to be more physically active was reported by six of the nine study participants. However, in spite of feeling motivated, four reported that their habits or behaviours had not been affected by the Activity coach. FEASIBILITY: Data was successfully stored in the deployed hardware as intended and the accelerometers were used enough, for the data to be analysable. One finding was that the subjective outcome goal attainment, was challenging to collect. A proposed mitigator for this is to use pre-defined goals in future studies, as opposed to having the study participants be completely free to formulate the goals themselves. CONCLUSIONS: It was confirmed that the Activity coach was easy to use. Furthermore, it might stimulate increased physical activity in a population of people with HF, who are physically inactive. The outcomes investigated seem feasible to include in a future efficacy trial. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05235763. Date of first registration: 11/02/2022.

Cohort profile: Data standards for cardiac rehabilitation structure and processes for the SWEDEHEART cardiac rehabilitation (SWEDEHEART-CR) registry.

Data standards for quality registries should be evidence-based and follow guideline recommendations. To optimally monitor quality of care, not only patient-level variables, but also centre-level variables need to be included. Here we describe the development of variables to audit the structure and processes in cardiac rehabilitation for patients after myocardial infarction, and the resulting data standards to be implemented in the Swedish quality registry for cardiac disease, SWEDEHEART. The methodology used for the development of international clinical data standards for the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) was followed. Based on national guidelines for secondary prevention, candidate variables were prepared, after which a multiprofessional expert group on cardiac rehabilitation selected key variables and assured face validity. An external reference group had the role of peer reviewing, ascertaining content validity and test-retest reliability. The process has resulted in 30 data standards to be introduced into the SWEDEHEART cardiac rehabilitation registry and administered on centre-level biannually. The data standards include measures of human resources, centre requirements and process-based metrics. Including registry variables which audit centre-level structure and processes is essential to improve benchmarking and standardize monitoring of quality of care, covering both services provided and patient outcomes.

Impact of walk advice alone or in combination with supervised or home-based structured exercise on patient-reported physical function and generic and disease-specific health related quality of life in patients with intermittent claudication, a secondary analysis in a randomized clinical trial.

BACKGROUND: Supervised exercise is an integral part of the recommended first-line treatment for patients with intermittent claudication (IC). By reflecting the patients' perspectives, patient-reported outcome measurements provide additional knowledge to the biomedical endpoints and are important outcomes to include when evaluating exercise interventions in patients with IC. We aimed to evaluate the one-year impact of three strategies: unsupervised Nordic pole walk advice (WA), WA + six months of home-based structured exercise (HSEP) or WA + six months of hospital-based supervised exercise (SEP) on health-related quality of life and patient-reported physical function in patients with IC. METHODS: This secondary exploratory analysis of a multi-center, randomized clinical trial compared three exercise strategies. The primary outcome of the secondary analysis was the one-year change in the 36-Item Short-Form (SF-36). Secondary outcomes were three- and six-months SF-36 changes alongside three, six- and 12-months changes in the disease-specific Vascular Quality of Life instrument (VascuQoL) and the Patient-Specific Functional Scale (PSFS). The Kruskal-Wallis test with Bonferroni-adjusted post-hoc tests were used for between-group comparisons. Effect size calculations were used to describe the size of observed treatment effects, and the clinical meaningfulness of observed changes in the VascuQoL summary score at one year was studied using established minimally important difference (MID) thresholds. RESULTS: A total of 166 patients with IC, mean age: 72.1 (SD 7.4) years, 41% women, were randomized. No significant between-group differences were observed over time for the SF-36 or the PSFS scores whereas some significant between-group differences were observed in the VascuQoL domain and summary scores over time, favoring SEP and/or HSEP over WA. The observed SF-36 and VascuQoL domain and summary score effect sizes were small to moderate, and many domain score effect sizes also remained unchanged over time. A significantly higher proportion of the patients in the SEP group reached the VascuQoL summary score MID of improvement in one year. CONCLUSION: Clinically important improvements were observed in SEP using the VascuQoL, while we did not observe any significant between-group differences using the SF-36. Whereas effect sizes for the observed changes over time were generally small, a significantly higher proportion of patients in SEP reached the VascuQoL MID of improvement. TRIAL REGISTRATION: NCT02341716, January 19, 2015 (retrospectively registered).

Associations of health-related quality of life with major adverse cardiovascular and cerebrovascular events for individuals with ischaemic heart disease: systematic review, meta-analysis and evidence mapping.

OBJECTIVE: To investigate the association between health-related quality of life (HRQoL) and major adverse cardiovascular and cerebrovascular events (MACCE) in individuals with ischaemic heart disease (IHD). METHODS: Medline(R), Embase, APA PsycINFO and CINAHL (EBSCO) from inception to 3 April 2023 were searched. Studies reporting association of HRQoL, using a generic or cardiac-specific tool, with MACCE or components of MACCE for individuals with IHD were eligible for inclusion. Risk of bias was assessed using the Newcastle-Ottawa Quality Assessment Scale to assess the quality of the studies. Descriptive synthesis, evidence mapping and random-effects meta-analysis were performed stratified by HRQoL measures and effect estimates. Between-study heterogeneity was assessed using the Higgins I2 statistic. RESULTS: Fifty-one articles were included with a total of 134 740 participants from 53 countries. Meta-analysis of 23 studies found that the risk of MACCE increased with lower baseline HeartQoL score (HR 1.49, 95% CI 1.16 to 1.93) and Short Form Survey (SF-12) physical component score (PCS) (HR 1.39, 95% CI 1.28 to 1.51). Risk of all-cause mortality increased with a lower HeartQoL (HR 1.64, 95% CI 1.34 to 2.01), EuroQol 5-dimension (HR 1.17, 95% CI 1.12 to 1.22), SF-36 PCS (HR 1.29, 95% CI 1.19 to 1.41), SF-36 mental component score (HR 1.18, 95% CI 1.08 to 1.30). CONCLUSIONS: This study found an inverse association between baseline values or change in HRQoL and MACCE or components of MACCE in individuals with IHD, albeit with between-study heterogeneity. Standardisation and routine assessment of HRQoL in clinical practice may help risk stratify individuals with IHD for tailored interventions. PROSPERO REGISTRATION NUMBER: CRD42021234638.

Healthcare professionals' perceptions of using a digital patient educational programme as part of cardiac rehabilitation in patients with coronary artery disease - a qualitative study.

BACKGROUND: Participation in cardiac rehabilitation in patients with coronary artery disease (CAD) remains underutilised. Digital educational programmes, as part of cardiac rehabilitation, are emerging as a means of increasing accessibility, but healthcare professionals' perceptions of implementing and using these programmes are not known. The aim of the study was therefore to explore healthcare professionals ̓ perceptions and experiences of implementing and using a digital patient educational programme (DPE) as part of cardiac rehabilitation after acute CAD. METHODS: Individual semi-structured interviews were performed with 12 nurses and physiotherapists, ten women with a median age of 49.5 (min 37- max 59) years, with experience of using the DPE as part of a phase II cardiac rehabilitation programme in Region Västra Götaland, Sweden. The interviews were transcribed verbatim and analysed with inductive content analysis according to Graneheim and Lundman. RESULTS: An overall theme was identified throughout the unit of analysis: "Digital patient education - a complement yet not a replacement". Within this theme, three main categories were identified: "Finding ways that make implementation work", "Accessibility to information for confident and involved patients" and "Reaching one another in a digital world". Each main category contains a number of sub-categories. CONCLUSIONS: This study adds new knowledge on healthcare professionals' perceptions of a digital patient educational programme as a valuable and accessible alternative to centre-based education programmes as part of cardiac rehabilitation for patients with CAD. The participants highlighted the factors necessary for a successful implementation, such as support through the process and sufficient time from the employer to learn the system and to create new routines in daily practice. Future research is needed to further understand the impact of digital education systems in the secondary prevention of CAD. Ultimately, hybrid models, where the choice of delivery depends on the preferences of the individual patient, would be the optimal model of care for the future.

Test-Retest Reliability, Agreement and Criterion Validity of Three Questionnaires for the Assessment of Physical Activity and Sedentary Time in Patients with Myocardial Infarction.

Regular physical activity (PA) and limited sedentary time (SED) are highly recommended in international guidelines for patients after a myocardial infarction (MI). Data on PA and SED are often self-reported in clinical practice and, hence, reliable and valid questionnaires are crucial. This study aimed to assess the test-retest reliability, criterion validity and agreement of two PA and one SED questionnaire commonly used in clinical practice, developed by the Swedish National Board of Health and Welfare (BHW) and the Swedish national quality register SWEDEHEART. Data from 57 patients (mean age 66 ± 9.2 years, 42 males) was included in this multi-centre study. The patients answered three questionnaires on PA and SED at seven-day intervals and wore an accelerometer for seven days. Test-retest reliability, criterion validity and agreement were assessed using Spearman's rho and linearly weighted kappa. Test-retest reliability was moderate for three of the six-sub questions (k = 0.43-0.54) within the PA questionnaires. For criterion validity, the correlation was fair within three of the six sub-questions (r = 0.41-0.50) within the PA questionnaires. The SED questionnaire had low agreement (k = 0.12) and criterion validity (r = 0.30). The studied questionnaires for PA could be used in clinical practice as a screening tool and/or to evaluate the level of PA in patients with an MI. Future research is recommended to develop and/or evaluate SED questionnaires in patients with an MI.

Cost-Effectiveness of Exercise Therapy in Patients with Intermittent Claudication-A Comparison of Supervised Exercise, Home-Based Structured Exercise, and Walk Advice from the SUNFIT Trial.

Hospital-based supervised exercise (SEP) is a guideline-recommended intervention for patients with intermittent claudication (IC). However, due to the limited availability of SEP, home-based structured exercise programs (HSEP) have become increasingly popular alongside the "go home and walk" advice. We evaluated the cost-effectiveness of walk advice (WA) with Nordic pole walking vs. SEP combined with WA or HSEP combined with WA. We used data from the SUNFIT RCT (NCT02341716) to measure quality-adjusted life-years (QALYs) over a 12-month follow-up, and economic costs were obtained from a hospital cost-per-patient accounting system. Incremental cost-effectiveness ratios (ICERs) were calculated, and uncertainty was assessed using nonparametric bootstrapping. The average health-care-cost per patient was similar in the WA (EUR 1781, n = 51) and HSEP (EUR 1820, n = 48) groups but higher in the SEP group (EUR 4619, n = 50, p-value < 0.01). Mean QALYs per patient during the follow-up were similar with no statistically significant differences. The findings do not support SEP as a cost-effective treatment for IC, as it incurred significantly higher costs without providing additional health improvements over WA with or without HSEP during the one-year observation period. The analysis also suggested that HSEP may be cost-effective compared to WA, but only with a 64% probability.

The Impact of Nordic Pole Walk Advice Alone or in Combination With Exercise Strategies on Daily Physical Activity in Patients With Intermittent Claudication: A Randomized Clinical Trial.

OBJECTIVE: The impact of exercise interventions on physical activity (PA) remains undetermined in intermittent claudication, which is why it is important to include objectively measured PA as an additional endpoint. The aim of this prespecified secondary analysis of a randomized clinical trial was to investigate the impact of unsupervised Nordic pole walk advice (WA) alone or in combination with hospital-based supervised exercise (SEP) or home-based structured exercise (HSEP) on PA in patients with intermittent claudication. METHODS: In total, 166 patients with intermittent claudication (mean age = 72 [SD = 7.4] y; 41% women) were randomized to 3 intermittent claudication-treatment strategies: WA, WA + SEP, or WA + HSEP. All patients received Nordic poles and standardized WA (≥30 min, 3 times weekly). Patients randomized to HSEP and SEP accepted participation in an additional 6-months exercise program. PA was measured with an accelerometer-based activPAL3 monitor for 7 days at baseline and at 3, 6, and 12 months. PA outcomes were steps per day, time spent within a stepping cadence ≥100 steps per minute, time spent upright, number of body transitions from sitting to standing, and number of sitting bouts of >30 minutes and >60 minutes. RESULTS: At 1 year, no intergroup differences were observed in any of the PA variables, whereas significant intergroup differences were observed at 3 months regarding time spent within a stepping time cadence ≥100 steps per minute. The mean change for HSEP (2.47 [SD = 10.85] min) was significantly different from the mean change for WA (-3.20 [SD = 6.24] min). At 6 months, the number of sitting bouts (>60 min) for SEP was significantly different from WA (mean change = 0.24 [SD = 0.69] vs -0.23 [SD = 0.81]). CONCLUSION: This study indicates that the addition of 6 months of HSEP or SEP does not improve PA at 1 year, as compared to unsupervised WA alone. Factors of importance for increasing PA in patients with intermittent claudication require further investigation. IMPACT: At the 1-year follow-up, the addition of intermittent claudication-tailored additional exercise strategies did not improve daily PA in patients with intermittent claudication compared with unsupervised Nordic pole WA alone. Future studies may explore the role of behavior change techniques to increase PA in this patient group.

Adult childhood cancer survivors' perceptions of factors that influence their ability to be physically active.

PURPOSE: Studies indicate that adult childhood cancer survivors do not achieve recommended physical activity levels. A deeper understanding of factors that influence their ability to be physically active is essential to identify individuals in need of support. The aim was to explore factors that influence adult childhood cancer survivor's ability to be physically active. METHOD: Semi-structured interviews were conducted from June to October 2020 with 20 adult childhood cancer survivors with a median age of 31 (min-max 20-47) years. Interviews were transcribed verbatim and analyzed with qualitative content analysis. RESULTS: Four main categories: "The impact of environmental factors," "Personal factors of importance," "Consequences of the treatment or disease," and "The impact of support from healthcare" and 10 sub-categories, were identified. Participants described how family habits and encouragement from others influenced their present ability to be physically active. Experienced benefits of physical activity were described as a facilitator for current physical activity while suffering from late complications was identified as a barrier. Participants highlighted the importance of specific and individualized physical activity recommendations. CONCLUSION: This study includes adult childhood cancer survivors several years after completion of treatment, hence highlighting the importance for support both during treatment and follow-up to sustain their physical activity. Healthcare providers need to identify individuals suffering from late complications, even several years after treatment; provide individualized physical activity recommendations; and educate families and schools about the importance of physical activity in childhood cancer survivorship. TRIAL REGISTRATION: This research project was registered in the Swedish National Database of Research and Development, identifier 273320, December 6, 2019 ( https://www.researchweb.org/is/vgr/project/273320 ).

Temporal trends in cardiovascular risk factors, lifestyle and secondary preventive medication for patients with myocardial infarction attending cardiac rehabilitation in Sweden 2006-2019: a registry-based cohort study.

OBJECTIVES: Registries have been highlighted as means to improve quality of care. Here, we describe temporal trends in risk factors, lifestyle and preventive medication for patients after myocardial infarction (MI) registered in the quality registry Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). DESIGN: A registry-based cohort study. SETTING: All coronary care units and cardiac rehabilitation (CR) centres in Sweden. PARTICIPANTS: Patients attending a CR visit at 1-year post-MI 2006-2019 were included (n=81 363, 18-74 years, 74.7% men). OUTCOME MEASURES: Outcome measures at 1-year follow-up included blood pressure (BP) <140/90 mm Hg, low-density lipoprotein-cholesterol (LDL-C)<1.8 mmol/L, persistent smoking, overweight/obesity, central obesity, diabetes prevalence, inadequate physical activity, and prescription of secondary preventive medication. Descriptive statistics and testing for trends were applied. RESULTS: The proportion of patients attaining the targets for BP<140/90 mmHg increased from 65.2% (2006) to 86.0% (2019), and LDL-C<1.8 mmol/L from 29.8% (2006) to 66.9% (2019, p<0.0001 both). While smoking at the time of MI decreased (32.0% to 26.5%, p<0.0001), persistent smoking at 1 year was unchanged (42.8% to 43.2%, p=0.672) as was the prevalence of overweight/obesity (71.9% to 72.9%, p=0.559). Central obesity (50.5% to 57.0%), diabetes (18.2% to 27.2%) and patients reporting inadequate levels of physical activity (57.0% to 61.5%) increased (p<0.0001 for all). From 2007, >90.0% of patients were prescribed statins and approximately 98% antiplatelet and/or anticoagulant therapy. Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker prescription increased from 68.7% (2006) to 80.2% (2019, p<0.0001). CONCLUSIONS: While little change was observed for persistent smoking and overweight/obesity, large improvements were observed for LDL-C and BP target achievements and prescription of preventive medication for Swedish patients after MI 2006-2019. Compared with published results from patients with coronary artery disease in Europe during the same period, these improvements were considerably larger. Continuous auditing and open comparisons of CR outcomes might possibly explain some of the observed improvements and differences.

Patients' Perceptions of Exercise-Based Cardiac Telerehabilitation after a Myocardial Infarction-A Qualitative Study.

To be able to design telerehabilitation programs targeting the needs and preferences of end-users, patients' in-depth perspectives are needed. To date, such studies are lacking and, therefore, the aim of the present study was to describe patients' perceptions of performing exercise-based cardiac telerehabilitation after a myocardial infarction (MI). Individual semi-structured interviews were performed with 15 patients (3 women, median age 69 years) after an MI who had participated in exercise-based cardiac telerehabilitation for three months. The interviews were transcribed verbatim and analyzed with inductive content analysis. An overall theme was defined as "Cardiac telerehabilitation-a new alternative for exercising that is easily accessible and up to date". Four categories, including "The important role of a physical therapist with expert knowledge", "Prerequisites playing an important role in the willingness to participate", "Making exercise accessible and adjustable" and "Inspiring future exercise", and 15 subcategories were identified. Understanding the patient's perspective is an important key to further improving and successfully implementing exercise-based cardiac telerehabilitation, as an alternative or adjunct to traditional, centre-based programs. The findings can serve to improve patient-physiotherapist interactions and to inform important aspects related to exercise, technology and a sense of security from an exercise-based cardiac telerehabilitation program.

The remote exercise SWEDEHEART study-Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT).

BACKGROUND: Despite proven benefits of exercise-based cardiac rehabilitation (EBCR), few patients with myocardial infarction (MI) participate in and complete these programs. STUDY DESIGN AND OBJECTIVES: The Remote Exercise SWEDEHEART study is a large multicenter registry-based cluster randomized crossover clinical trial with a planned enrollment of 1500 patients with a recent MI. Patients at intervention centers will be offered supervised EBCR, either delivered remotely, center-based or as a combination of both modes, as self-preferred choice. At control centers, patients will be offered supervised center-based EBCR, only. The duration of each time period (intervention/control) for each center will be 15 months and then cross-over occurs. The primary aim is to evaluate if remotely delivered EBCR, offered as an alternative to center-based EBCR, can increase participation in EBCR sessions. The proportion completers in each group will be presented in a supportive responder analysis. The key secondary aim is to investigate if remote EBCR is as least as effective as center-based EBCR, in terms of physical fitness and patient-reported outcome measures. Follow-up of major adverse cardiovascular events (cardiovascular- and all-cause mortality, recurrent hospitalization for acute coronary syndrome, heart failure hospitalization, stroke, and coronary revascularization) will be performed at 1 and 3 years. Safety monitoring of serious adverse events will be registered, and a cost-effectiveness analysis will be conducted to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control. CONCLUSIONS: The cluster randomized crossover clinical trial Remote Exercise SWEDEHEART study is evaluating if participation in EBCR sessions can be increased, which may contribute to health benefits both on a group level and for individual patients including a more equal access to health care. TRIAL REGISTRATION: The study is registered at ClinicalTrials.gov (Identifier: NCT04260958).

Effectiveness of a behavioral medicine intervention in physical therapy on secondary psychological outcomes and health-related quality of life in exercise-based cardiac rehabilitation: a randomized, controlled trial.

BACKGROUND: Interventions promoting adherence to exercise-based cardiac rehabilitation (exCR) are important to achieve positive physical and psychological outcomes, but knowledge of the added value of behavioral medicine interventions for these measures is limited. The aim of the study was to investigate the added value of a behavioral medicine intervention in physical therapy (BMIP) in routine exCR on psychological outcomes and health-related quality of life (HRQoL) versus routine exCR alone (RC). METHODS: A total of 170 patients with coronary artery disease (136 men), mean age 62.3 ± 7.9 years, were randomized at a Swedish university hospital to a BMIP plus routine exCR or to RC for four months. The outcome assessments included HRQoL (SF-36, EQ-5D), anxiety and depression (HADS), patient enablement and self-efficacy and was performed at baseline, four and 12 months. Between-group differences were tested with an independent samples t-test and, for comparisons within groups, a paired t-test was used. An intention-to-treat and a per-protocol analysis were performed. RESULTS: No significant differences in outcomes between the groups were shown between baseline and four months or between four and 12 months. Both groups improved in most SF-36 domains, EQ-VAS and HADS anxiety at the four-month follow-up and sufficient enablement remained at the 12-months follow-up. CONCLUSION: A BMIP added to routine exCR care had no significant effect on psychological outcomes and HRQoL compared with RC, but significant improvements in several measures were shown in both groups at the four-month follow-up. Since recruited participants showed a better psychological profile than the general coronary artery disease population, further studies on BMIP in exCR, tailored to meet individual needs in broader patient groups, are needed. Trial registration number NCT02895451, 09/09/2016, retrospectively registered.

Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial.

AIMS: Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise programmes (SEPs) are underutilized, while home-based structured exercise programmes (HSEPs) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. The aim of the study was to compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC. METHODS AND RESULTS: This three-armed, multicentre randomized clinical trial enrolled patients with IC; all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs. HSEP regarding the 6-min walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the walking impairment questionnaire. Outcomes were assessed at baseline, 3, 6, and 12 months by a blinded evaluator. Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP and SEP, 24 and 26% patients, respectively, were fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0 to 12 months was -11.6 m, 95% confidence interval: -36.4 to 13.0 m (i.e. within the pre-specified non-inferiority margin). CONCLUSION: The HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at 1 year. REGISTRATION: ClinicialTrials.gov: NCT02341716.

Organizational and patient-level predictors for attaining key risk factor targets in cardiac rehabilitation after myocardial infarction: The Perfect-CR study.

BACKGROUND: Benefits of cardiac rehabilitation (CR) programme components on attaining risk factor targets post-myocardial infarction (MI) and their predictive strength relative to patient characteristics remain unclear. We aimed to identify organizational and patient-level predictors of risk factor target attainment at one-year post-MI. METHODS: In this observational study data on CR organization at 78 Swedish CR centres was collected and merged with patient-level registry data (n = 7549). Orthogonal partial least squares discriminant analysis identified predictors (Variables of Importance for the Projection (VIP) values >0.8) of attaining low-density lipoprotein-cholesterol (LDL-C) <1.8 mmol/L, blood pressure (BP) <140/90 mmHg and smoking abstinence. RESULTS: The strongest predictors (VIP [95% CI]) for attaining LDL-C and BP targets were offering psychosocial management (2.14 [1.78-2.50]; 2.45 [1.91-2.99]), having a psychologist in the CR team (1.62 [1.36-1.87]; 2.05 [1.67-2.44]), extended opening hours (2.13 [2.00-2.27]; 1.50 [0.91-2.10]), adequate facilities (1.54 [0.91-2.18]; 1.89 [1.38-2.40]), and having a medical director (1.70 [0.91-2.48]; 1.46 [1.04-1.88]). The strongest patient-level predictors of attaining LDL-C and/or BP targets were low baseline LDL-C (3.95 [3.39-4.51]) and having no history of hypertension (2.93 [2.60-3.26]), respectively, followed by exercise-based CR participation (1.38 [0.66-2.10]; 1.46 [1.14-1.78]). For smoking abstinence, the strongest organizational predictor was varenicline being prescribed by CR physicians (1.88 [0.95-2.80]) and patient-level predictors were participation in exercise-based CR (2.47 [2.07-2.88]) and group education (1.92 [1.43-2-42]), and no cardiovascular disease history (2.13 [1.78-2.48]). CONCLUSIONS: We identified multiple CR organizational and patient-level predictors of attaining risk factor targets post-MI. These results may influence the future design of comprehensive CR programmes.

How to optimize the adherence to a guideline-directed medical therapy in the secondary prevention of cardiovascular diseases: a clinical consensus statement from the European Association of Preventive Cardiology.

A key factor to successful secondary prevention of cardiovascular disease (CVD) is optimal patient adherence to treatment. However, unsatisfactory rates of adherence to treatment for CVD risk factors and CVD have been observed consistently over the last few decades. Hence, achieving optimal adherence to lifestyle measures and guideline-directed medical therapy in secondary prevention and rehabilitation is a great challenge to many healthcare professionals. Therefore, in this European Association of Preventive Cardiology clinical consensus document, a modern reappraisal of the adherence to optimal treatment is provided, together with simple, practical, and feasible suggestions to achieve this goal in the clinical setting, focusing on evidence-based concepts.