Cardiac rehabilitation for patients with obesity: lessons learned from the OPTICARE XL trial.

Obesity is a known and commonly encountered risk factor for the development of cardiac diseases. Patients with cardiac diseases who also have obesity do not benefit optimally from standard cardiac rehabilitation (CR) programs. Exercises performed during CR are not the best fit for patients with obesity and counselling sessions often do not address their specific needs. OPTICARE XL is the first large multicentre randomised controlled trial to investigate the added value of a dedicated one-year CR program specifically designed for patients with obesity and integrated in daily practice. The short-term effects on body weight and physical activity were promising and patients with obesity experienced the program as highly desirable. However, the OPTICARE XL CR program did not show long-term added value compared with standard CR on health-related quality of life, psychosocial well-being, body weight, physical activity and physical fitness, nor on costs. The current article offers an overview of the background of this trial and discusses the most important results of the OPTICARE XL trial and the reasons behind the unanticipated long-term outcomes. Furthermore, it offers recommendations for future research and how to redesign the OPTICARE XL CR program to expand the short-term results.

Physical activity and sedentary behaviour changes during and after cardiac rehabilitation: Can patients be clustered?

OBJECTIVE: To identify clusters of patients according to changes in their physical behaviour during and after cardiac rehabilitation, and to predict cluster membership. METHODS: The study included 533 patients (mean age 57.9 years; 18.2% females) with a recent acute coronary syndrome who participated in a 12-week multi-disciplinary cardiac rehabilitation programme, within a cohort study design. Physical behaviour (light physical activity, moderate-to vigorous physical activity, step count, and sedentary behaviour) was measured using accelerometry at 4 timepoints. To identify clusters of patients according to changes in physical behaviour during and after cardiac rehabilitation, latent class trajectory modelling was applied. Baseline factors to predict cluster membership were assessed using multinomial logistic regression. RESULTS: During and after cardiac rehabilitation, 3 separate clusters were identified for all 4 physical behaviour outcomes: patients with steady levels (comprising 68-83% of the patients), and improving (6-21%) or deteriorating (4-23%) levels. Main predictor for membership to a specific cluster was baseline physical behaviour. Patients with higher starting physical behaviour were more likely to be a member of clusters with deteriorating levels. CONCLUSION: Separate clusters of physical behaviour changes during and after cardiac rehabilitation could be identified. Clusters were mainly distinguished by baseline physical behaviour level.

Effects of a Dedicated Cardiac Rehabilitation Program for Patients With Obesity on Body Weight, Physical Activity, Sedentary Behavior, and Physical Fitness: The OPTICARE XL Randomized Controlled Trial.

OBJECTIVE: Previously published results of the OPTICARE XL open label randomized controlled trial showed no added value of OPTICARE XL CR, a dedicated cardiac rehabilitation (CR) program for patients with obesity, with respect to health-related quality of life (primary outcome). This clinical trial studied the effects of OPTICARE XL CR on several secondary outcomes, which included body weight, physical activity, sedentary behavior, and physical fitness. METHODS: Patients with coronary artery disease or atrial fibrillation and body mass index ≥ 30 were randomized to OPTICARE XL CR (n = 102) or standard CR (n = 99). OPTICARE XL CR was a 1-year group intervention, specifically designed for patients with obesity that included aerobic and strength exercise, behavioral coaching, and an aftercare program. Standard CR consisted of a 6- to 12-week group aerobic exercise program, supplemented with cardiovascular lifestyle education. Study end points included body weight, physical activity, sedentary behavior (accelerometer), and physical fitness (6-Minute Walk Test and handgrip strength), which were evaluated 6 months after the end of CR (primary endpoint) and 3 months after the start of CR. RESULTS: Six months after completion of either program, improvements in body weight, physical activity, sedentary behavior, and physical fitness were similar between the groups. Three months after CR start, patients randomized to OPTICARE XL CR showed greater weight loss (mean change = -3.6 vs -1.8 kg) and a larger improvement in physical activity (+880 vs +481 steps per day) than patients randomized to standard CR. CONCLUSION: Patients allocated to OPTICARE XL CR lost significantly more body weight and showed promising results with respect to physical activity 3 months after the start of CR; however, these short-term results were not expanded or sustained in the longer term. IMPACT: Patients with obesity do not benefit from standard CR programs. The new OPTICARE XL CR program showed its effects in the short term on weight loss and physical activity, and, therefore, redesign of the aftercare phase is recommended.

Echocardiographic follow-up after cardiac rehabilitation designed for patients with obesity.

We hypothesize that a novel tailor-made cardiac rehabilitation (CR) program for obesity patients (OPTICARE XL) has better outcomes as compared to usual CR regarding parameters of cardiac function as measured by conventional and advanced transthoracic echocardiography. This is an open-label, randomized controlled trial. Inclusion criteria were: patients referred to CR with a body mass index (BMI) ≥30 kg/m2, and age ≥18 years with either coronary artery disease or nonvalvular atrial fibrillation. The experimental group participated in OPTICARE XL and the controls received the usual CR. Subjects randomized to OPTICARE XL received on top of usual CR behavioural therapy for a healthy diet and an active lifestyle for the first 12 weeks. Also, the exercise program was more tailored. Furthermore, a behavioural after-care program was organized with 6 meetings between weeks 13-52. Transthoracic (speckle tracking) echocardiography was performed at baseline and one-year follow-up. A total of 42 patients completed the follow-up, 21 in both groups. There was a mild but statistically significant reduction in weight over time, however, this was comparable between groups. There was no improvement observed in any of the echocardiographic parameters. In conclusion, cardiac function in obesity patients was not improved one-year after a novel tailor-made CR program (OPTICARE XL) as compared to usual CR.

Cardiac rehabilitation designed for patients with obesity: OPTICARE XL RCT results on health-related quality of life and psychosocial well-being.

Purpose We studied the effectiveness of a new cardiac rehabilitation (CR) program developed for patients with obesity compared with standard CR on HRQOL and psychosocial well-being.Materials and methods OPTICARE XL was a multicentre RCT in patients with cardiac disease and obesity (Netherlands Trial Register: NL5589). Patients were randomized to OPTICARE XL CR (n = 102) or standard CR (n = 99). The one-year OPTICARE XL CR group program included endurance and resistance exercises, behavioural coaching, and after-care. Standard CR consisted of a 6- to 12-week endurance exercise group program, and cardiovascular lifestyle education. Primary endpoint was HRQOL (MacNew) at six months post CR. Second, we assessed anxiety and depression (both HADS), fatigue (FSS), and participation in society (USER-P).Results In both groups, improvements in HRQOL were observed six months post CR. Mean HRQOL improved from 4.92 to 5.40 in standard CR [mean change (95% CI): 0.48 (0.28, 0.67)] and from 4.96 to 5.45 in OPTICARE XL CR (mean change (95% CI): 0.49 (0.29, 0.70), without between-group differences. Psychosocial well-being improvements within both groups were obtained at six months post CR, regardless of allocated program.Conclusions OPTICARE XL CR did not have added value in improving HRQOL and psychosocial well-being in patients with obesity.Implications for rehabilitationMore than a third of cardiac patients suffers from obesity, and standard cardiac rehabilitation (CR) programs are suboptimal in this increasing patient population.The OPTICARE XL CR program is a state-of-the art, one-year CR program designed for patients with obesity including aerobic and strength exercises, behavioural coaching towards a healthy diet and an active lifestyle, and after-care.Improvements in HRQOL and psychosocial well-being were comparable between patients with obesity allocated to standard CR and OPTICARE XL CR.Therefore, there was no additional benefit of OPTICARE XL CR.

Assessing Changes in Fear of Movement in Patients attending Cardiac Rehabilitation: Responsiveness of the TSK-NL Heart Questionnaire.

OBJECTIVES: The primary objective was to determine the responsiveness of the Dutch version of the 13-item Tampa Scale for Kinesiophobia for cardiac patients (TSK-NL Heart). The secondary objective was to assess changes in kinesiophobia during cardiac rehabilitation. METHODS: Kinesiophobia was measured pre- and post-cardiac rehabilitation using the TSK-NL Heart questionnaire in 109 cardiac patients (61 years; 76% men). The effect size of kinesiophobia score changes was calculated for the full population. A measure that is responsive to change should produce higher effects sizes in patients in whom kinesiophobia improves. Therefore, effect sizes were also calculated for patients who did or did not improve on selected external measures. For this step, the Cardiac Anxiety Questionnaire (CAQ) and the Hospital Anxiety and Depression Scale (HADS) were completed as external measures in a subsample of 58 patients. RESULTS: The effect size of the TSK-NL Heart for the full study population was small (0.29). In line with the study hypothesis the effect size was higher (moderate) for patients with improved CAQ (0.52) and HADS scores (0.54). Prevalence of high kinesiophobia levels decreased from 40% pre-cardiac rehabilitation to 26% post-cardiac rehabilitation (p = 0.004). CONCLUSION: The TSK-NL Heart has moderate responsiveness and can be used to measure changes in kinesiophobia. Improvements in kinesiophobia were observed during cardiac rehabilitation. Nevertheless, high levels of kinesiophobia were still highly prevalent post-cardiac rehabilitation.

Heart failure and promotion of physical activity before and after cardiac rehabilitation (HF-aPProACH): a study protocol.

AIMS: Lifestyle changes, such as increasing physical activity (PA), are a cornerstone of treatment of patients with chronic heart failure (HF). However, improving PA in HF patients is challenging, and low participation rates for cardiac rehabilitation (CR) as well as relapse to low PA levels after CR are major issues. We designed a randomized controlled trial to investigate if PA monitoring with motivational feedback before and after centre-based CR in HF patients with reduced ejection fraction (HFrEF) will lead to a clinically meaningful increase in physical fitness. METHODS AND RESULTS: A randomized controlled trial will be conducted in a sample of 180 HFrEF patients (New York Heart Association Class II/III) who are referred to 12-week standard CR. Patients will be randomized (2:1) to (1) standard of care (SoC) plus wearing a PA monitoring device (Fitbit Charge 3) with personalized step goals, feedback and motivation or (2) SoC only. The intervention lasts ±7 months: 4-5 weeks before CR, 12 weeks during CR and 12 weeks after CR. Measurements will take place at three time points. The primary endpoint is the change in the distance in 6-min walking test (6MWT) over the entire study period. Other endpoints include step count, grip strength, quality of life and all-cause mortality or hospitalization. CONCLUSIONS: HF-aPProACH will provide novel information on the effectiveness of remote PA stimulation and feedback before, during and after standard CR using a commercially available device to improve physical fitness in HFrEF patients.

Physical Activity and Sedentary Behavior in Cardiac Rehabilitation: Does Body Mass Index Matter?

OBJECTIVE: The purpose of this study was to investigate the relationship between body mass index (BMI) class and physical activity and sedentary behavior in patients with acute coronary syndrome (ACS) during cardiac rehabilitation (CR). METHODS: This study was a secondary analysis of the OPTICARE trial. Physical activity and sedentary behavior were measured in participants with ACS (n = 359) using actigraphy at baseline, directly after completion of a multidisciplinary 12-week exercise-based CR program and 9 months thereafter. Outcome measures were step count and duration of time (percentage of wear time) spent in light physical activity, moderate-to-vigorous physical activity, and sedentary behavior. Participants were classified as normal weight (BMI = 18.5-24.99 kg/m2; n = 82), overweight (BMI = 25.0-29.99 kg/m2; n = 182), or obese (BMI ≥ 30.0 kg/m2; n = 95). Linear mixed-effects models were applied to study the relationship between BMI class and physical activity and sedentary behavior. RESULTS: At the start of CR, compared with participants with normal weight, participants with obesity made on average 1.11 steps fewer per minute (952 steps/d), spent 2.9% (25 min/d) less time in light physical activity, and spent 3.31% (28 min/d) more time in sedentary behavior. Participants of all BMI classes improved their physical activity and sedentary behavior levels similarly during CR, and these improvements were maintained after completion of CR. CONCLUSION: Participants with ACS who had obesity started CR with a less favorable physical activity and sedentary behavior profile than that of participants with normal weight. Because all BMI classes showed similar improvement during CR, this deficit was preserved. IMPACT: This study indicates that reconsideration of the CR program in the Netherlands for patients with ACS and obesity is warranted, and development of more inclusive interventions for specific populations is needed. A new program for people with obesity should include added counseling on increasing physical activity and preventing sedentary behavior to facilitate weight loss and reduce mortality risk. LAY SUMMARY: People with ACS who have obesity are less active and sit more than individuals with normal weight, both during and after CR. This study suggests that CR needs to be changed to help individuals increase their physical activity to help them lose weight and reduce their risk of death.

Health-related quality of life and cardiac rehabilitation: Does body mass index matter?

OBJECTIVE: To investigate the relation between body mass index class and changes in health-related quality of life in patients participating in cardiac rehabilitation. DESIGN: Prospective cohort study. PATIENTS: A total of 503 patients with acute coronary syndrome. METHODS: Data from the OPTICARE trial were used, in which health-related quality of life was measured with the MacNew Heart Disease HRQOL Instrument at the start, directly after, and 9 months after completion of cardiac rehabilitation. Patients were classed as normal weight, overweight, or obese. RESULTS: During cardiac rehabilitation, global health-related quality of life improved in patients in all classes of body mass index. Patients classed as overweight had a significantly greater improvement in social participation than those classed as normal weight (5.51-6.02 compared with 5.73-5.93, respectively; difference in change 0.30, p = 0.025). After completion of cardiac rehabilitation, health-related quality of life continued to improve similarly in patients in all classes of body mass index. CONCLUSION: Health-related quality of life improved during cardiac rehabilitation in patients of all classes of body mass index. Patients classed as overweight showed the greatest improvement. The beneficial effects were maintained during extended follow-up after completion of cardiac rehabilitation.

Fear of movement in patients attending cardiac rehabilitation: A validation study.

OBJECTIVES: To determine the psychometric properties of a questionnaire to assess fear of movement (kinesiophobia): the Tampa Scale for Kinesiophobia (TSK-NL Heart), and to investigate the prevalence of kinesiophobia in patients attending cardiac rehabilitation. METHODS: A total of 152 patients were evaluated with the TSK-NL Heart during intake and 7 days later. Internal consistency, test-retest reliability and construct validity were assessed. For construct validity, the Cardiac Anxiety Questionnaire (CAQ) and the Hospital Anxiety and Depression Scale (HADS) were used. The factor structure of the TSK-NL Heart was determined by a principal component analysis (PCA). RESULTS: After removal of 4 items due to low internal consistency, the TSK-NL Heart showed substantial reliability (intraclass correlation coefficient; ICC: 0.80). A strong positive correlation was found between the TSK-NL Heart and the CAQ (rs: 0.61). Strong positive correlations were found between the TSK-NL Heart and the HADS (Anxiety) (rs: 0.60) and between the TSK-NL Heart and the CAQ (rs: 0.61). The PCA revealed a 3-factor structure as most suitable (fear of injury, avoidance of physical activity, perception of risk). High levels of kinesiophobia were found in 45.4% of patients. CONCLUSION: The 13-item TSK-NL Heart has good psychometric properties, and we recommend using this version to assess kinesiophobia, which is present in a substantial proportion of patients referred for cardiac rehabilitation.

Association Between Exercise Capacity and Health-Related Quality of Life During and After Cardiac Rehabilitation in Acute Coronary Syndrome Patients: A Substudy of the OPTICARE Randomized Controlled Trial.

OBJECTIVE: To examine the strength of the association between exercise capacity and health-related quality of life (HRQOL) during and after cardiac rehabilitation (CR) in patients with acute coronary syndrome (ACS) who completed CR. DESIGN: Prospective cohort study. SETTING: Outpatient CR center. PARTICIPANTS: Patients (N=607) with ACS who completed CR. INTERVENTIONS: Multidisciplinary 12-week exercise-based CR program. MAIN OUTCOME MEASURES: At baseline (pre-CR), the 6-Minute Walk Test (6MWT) was performed to determine exercise capacity, and the MacNew Heart Disease Health-related Quality of Life questionnaire was used to assess HRQOL. Measurements were repeated immediately after completion of CR (post-CR): at 12 months and 18 months follow-up. Multivariable linear regression, including an interaction term for time and exercise capacity, was applied to study the association between exercise capacity and HRQOL at different time points relative to CR, whereas model parameters were estimated by methods that accounted for dependency of repeated observations within individuals. RESULTS: Mean age in years ± SD was 58±8.9 and 82% of participants were male. Baseline mean 6MWT distance in meters ± SD was 563±77 and median (25th-75th percentile) global HRQOL was 5.5 (4.6-6.1) points. Mean 6MWT distance (P<.001) and the global (P<.001), physical (P<.001), emotional (P<.001) and social (P<.001) domains of HRQOL improved significantly during CR and continued to improve during follow-up post-CR. Independent of the timing relative to CR (ie, pre-CR, post-CR, or during follow-up), a difference of 10 m 6MWT distance was associated with a mean difference in the global HRQOL domain of 0.007 (95% confidence interval [CI], 0.001-0.014) points (P=.029) and a mean difference in the physical domain of 0.009 (95% CI, 0.001-0.017) points (P=.023). CONCLUSIONS: Better exercise capacity was significantly associated with higher scores on the global and physical domains of HRQOL, irrespective of the timing relative to CR, albeit these associations were weak. Hence, CR programs in secondary prevention should continue to aim at enhancing both HRQOL and exercise capacity.