Applying Exercise Capacity and Physical Activity as Single vs Composite Endpoints for Trials of Cardiac Rehabilitation Interventions: Rationale, Use-case, and a Blueprint Method for Sample Size Calculation.

OBJECTIVE: To conceptualize a composite primary endpoint for parallel-group RCTs of exercise-based cardiac rehabilitation (CR) interventions and to explore its application and statistical efficiency. DESIGN: We conducted a statistical exploration of sample size requirements. We combined exercise capacity and physical activity for the composite endpoint (CE), both being directly related to reduced premature mortality in patients with cardiac diseases. Based on smallest detectable and minimal clinically important changes (change in exercise capacity of 15 W and change in physical activity of 10 min/day), the CE combines 2 dichotomous endpoints (achieved/not achieved). To examine statistical efficiency, we compared sample size requirements based on the CE to single endpoints using data from 2 completed CR trials. SETTING: Cardiac rehabilitation phase III. PARTICIPANTS: Patients in cardiac rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE(S): Exercise capacity (Pmax assessed by incremental cycle ergometry) and physical activity (daily minutes of moderate to vigorous physical activity assessed by accelerometry). RESULTS: Expecting, for example, a 10% between-group difference and improvement in the clinical outcome, the CE would increase sample size by up to 21% or 61%, depending on the dataset. When expecting a 10% difference and designing an intervention with the aim of non-deterioration, the CE would allow to reduce the sample size by up to 55% or 70%. CONCLUSIONS: Trialists may consider the utility of the CE for future studies in exercise-based CR to reduce sample size requirements. However, perhaps surprisingly at first, the CE could also lead to an increased sample size needed, depending on the observed baseline proportions in the trial population and the aim of the intervention.

Near infrared spectroscopy to evaluate the effect of a hybrid exercise programme on peripheral muscle metabolism in patients with intermittent claudication: an exploratory PROSECO-IC sub study.

Intermittent claudication (IC) is characterized by decreased blood flow and oxygen delivery to the lower-limb muscles, resulting in pain and impaired functional capacity. This study evaluated the effects of a 12-week hybrid walking intervention on muscle oxygenation and functional capacity in 38 patients with IC (Rutherford I-III). Functional capacity was evaluated by means of two different treadmill test protocols and a six-minute walk test (6MWT). Muscle oxygenation was assessed during the treadmill tests using near-infrared spectroscopy. After the intervention, maximal walking distance was significantly increased (p < 0.001) during the progressive maximal treadmill test (mean (SD): +155 (SD 177) metres) and 6MWT (+18 (SD 29) metres) metres, with concomitant improvements in muscle oxygenation measures. Deoxygenation was slower during the progressive maximal test (p < 0.001) and reoxygenation was faster during recovery (p = 0.045). During the more submaximal test, oxygenated haemoglobin was better preserved (p = 0.040). Slower deoxygenation was more pronounced in the high responders of the progressive maximal treadmill test (p = 0.002). The findings suggest that preserved oxygen availability and slower deoxygenation during exercise could partly explain the improvements in functional capacity.

The Use of Near Infrared Spectroscopy to Evaluate the Effect of Exercise on Peripheral Muscle Oxygenation in Patients with Lower Extremity Artery Disease: A Systematic Review.

OBJECTIVE: Near infrared spectroscopy (NIRS) has been suggested as a new diagnostic tool in patients with lower extremity artery disease (LEAD). The aim of this systematic review was to summarise the impact of exercise therapy on lower limb muscle oxygenation, evaluated by NIRS, in patients with LEAD, and to give an overview on NIRS instruments and methodology. DATA SOURCES: MEDLINE and Embase. REVIEW METHODS: A systematic search was conducted in MEDLINE and Embase, from the earliest date available until 16 March 2020, to identify peer reviewed studies involving the use of NIRS in the evaluation of exercise training on muscle oxygenation in patients with LEAD. Primary outcomes were NIRS derived variables during treadmill exercise. Effect sizes were calculated as standardised mean differences. Assessment of methodological quality was done using a combined checklist from the Cochrane bias and the quality assessment tool for before and after studies without a control group. RESULTS: Eleven original trials were included involving 16 exercise groups and four control groups. Tissue saturation index (TSI) at rest remained unchanged following the exercise interventions. Exercise training increased time to minimum TSI during exercise (range effect sizes: +0.172 to +0.927). In addition, exercise training led to a faster recovery to half and full TSI rest values in most intervention groups (range effect sizes -0.046 to -0.558 and -0.269 to -0.665, respectively). Finally, NIRS data reproducibility and analytic methods were under reported in the included studies. CONCLUSION: The available data suggest that exercise training improves de-oxygenation and re-oxygenation patterns, as measured with NIRS, in patients with LEAD. Whereas NIRS is a promising tool in the evaluation of LEAD, the low number of randomised controlled trials, as well as large heterogeneity in NIRS assessment methods, outcome measures, and instrumentation, warrants more research to better understand the role of muscle oxygenation associated with exercise induced improvements in walking capacity.

Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial.

BACKGROUND: Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. OBJECTIVE: The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. METHODS: Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients' experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). RESULTS: A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; Pinteraction=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; Pinteraction=.004; effect size of -0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; Pinteraction=.004; effect size of -0.36) remained constant, but deteriorated in UC. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. TRIAL REGISTRATION: ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-016781.

Home-Based Rehabilitation With Telemonitoring Guidance for Patients With Coronary Artery Disease (Short-Term Results of the TRiCH Study): Randomized Controlled Trial.

BACKGROUND: Cardiac rehabilitation (CR) is an essential part of contemporary coronary heart disease management. However, patients exiting a center-based CR program have difficulty retaining its benefits. OBJECTIVE: We aimed to evaluate the added benefit of a home-based CR program with telemonitoring guidance on physical fitness in patients with coronary artery disease (CAD) completing a phase II ambulatory CR program and to compare the effectiveness of this program in a prolonged center-based CR intervention by means of a randomized controlled trial. METHODS: Between February 2014 and August 2016, 90 CAD patients (unblinded, mean age 61.2 years, SD 7.6; 80/90, 89.0% males; mean height 1.73 m, SD 0.7; mean weight 82.9 kg, SD 13; mean body mass index 27.5 kg/m2, SD 3.4) who successfully completed a 3-month ambulatory CR program were randomly allocated to one of three groups: home-based (30), center-based (30), or control group (30) on a 1:1:1 basis. Home-based patients received a home-based exercise intervention with telemonitoring guidance consisting of weekly emails or phone calls; center-based patients continued the standard in-hospital CR, and control group patients received the usual care including the advice to remain physically active. All the patients underwent cardiopulmonary exercise testing for assessment of their peak oxygen uptake (VO2 P) at baseline and after a 12-week intervention period. Secondary outcomes included physical activity behavior, anthropometric characteristics, traditional cardiovascular risk factors, and quality of life. RESULTS: Following 12 weeks of intervention, the increase in VO2 P was larger in the center-based (P=.03) and home-based (P=.04) groups than in the control group. In addition, oxygen uptake at the first (P-interaction=.03) and second (P-interaction=.03) ventilatory thresholds increased significantly more in the home-based group than in the center-based group. No significant changes were observed in the secondary outcomes. CONCLUSIONS: Adding a home-based exercise program with telemonitoring guidance following completion of a phase II ambulatory CR program results in further improvement of physical fitness and is equally as effective as prolonging a center-based CR in patients with CAD. TRIAL REGISTRATION: ClinicalTrials.gov NCT02047942; https://clinicaltrials.gov/ct2/show/NCT02047942 (Archived by WebCite at http://www.webcitation.org/70CBkSURj).

Cardiac patients show high interest in technology enabled cardiovascular rehabilitation.

BACKGROUND: Cardiac rehabilitation (CR) can slow or reverse the progression of cardiovascular disease (CVD). However, uptake of community-based CR is very low. E-cardiology, e-health and technology solutions for physical activity uptake and monitoring have evolved rapidly and have potential in CVD management. However, it is unclear what the current technology usage is of CVD patients, and their needs and interests for technology enabled CR. METHODS: A technology usage questionnaire was developed and completed by patients from a supervised ambulatory CR program and an adult congenital heart disease clinic and from two community-based CR programs. Results were described and related with age, gender and educational level by Spearman correlations. RESULTS: Of 310 patients, 298 patients (77 % male; mean age 61,7 ± 14,5 years) completed at least 25 questions of the survey and were included in the analysis (completion rate 96 %). Most (97 %) patients had a mobile phone and used the internet (91 %). Heart rate monitors were used by 35 % and 68 % reported to find heart rate monitoring important when exercising at home. Physical activity monitoring was reported by 12 % of the respondents. Respondents were interested in CR support through internet (77 %) and mobile phone (68 %). Many patients reported interest in game-based CR (67 %) and virtual rehabilitation (58 %). At least medium interest in technology enabled CR was reported by 75 % of the patients. Interest decreased with increasing age (r = -0.16; p = 0.005). CONCLUSIONS: CVD patients show interest for technology enabled home-based CR. Our results could guide the design of a technology-based, virtual CR intervention.

The concurrent validity and test-retest reliability of a submaximal exercise test in adolescents with autism.

PURPOSE: There is a need for valid and reliable clinical assessment tools to assess cardiorespiratory fitness (CRF) levels in adolescents with autism. Therefore, this study aimed to examine the concurrent validity and test-retest reliability of the Astrand-Rhyming Test (ART) in this population. MATERIALS AND METHODS: 45 adolescents with autism aged 12-18 years (n = 32 males, 14.47 ± 1.79 years) performed the ART twice (test-retest reliability) and completed a maximal cardiopulmonary exercise test (CPET) (concurrent validity). Reliability parameters included Pearson correlations, intraclass correlation coefficients (ICCs), standard error of measurements (SEM), minimal detectable changes (MDC), coefficients of variation, paired sample t-tests, linear regressions and Bland-Altman plots. The concurrent validity was evaluated with Pearson correlations, ICCs, paired sample t-tests, linear regressions and Bland-Altman plots. RESULTS: Strong test-retest reliability (r = 0.84-0.85, ICC = 0.84-0.85) was found for the ART, but the wide limits of agreement intervals suggest the presence of substantial variability. The large SEM (4.73-5.08 mL/kg/min) and MDC (13.20-14.07 mL/kg/min) values suggest lower absolute reliability. Moderate to strong levels of association (r = 0.74-0.75) and agreement (ICC = 0.59-0.66) were found between estimated (ART1) and measured (CPET) VO2 max levels, but significant systematic differences (5.71-8.82 mL/kg/min) were observed. CONCLUSION: The ART is an accessible and promising method to monitor submaximal CRF levels over time but is less appropriate to estimate maximal CRF levels in this population.

Adolescents with autism are at increased risk of exhibiting low cardiorespiratory fitness (CRF) levels and as a result, placing them at risk for poor physical and mental health outcomes.In clinical practice, the CRF levels of this population should be screened and monitored routinely to identify those at risk and most likely to benefit from a targeted intervention.A submaximal exercise test appears to be feasible in adolescents with autism.The Astrand-Rhyming Test shows good reliability to monitor submaximal CRF levels over time, but is less appropriate to estimate maximal CRF levels in adolescents with autism.The use of the age correction factor of the Astrand-Rhyming Test nomogram is not required to adequately estimate CRF levels in adolescents with autism.

Improving cardiovascular risk stratification through multivariate time-series analysis of cardiopulmonary exercise test data.

Nowadays cardiorespiratory fitness (CRF) is assessed using summary indexes of cardiopulmonary exercise tests (CPETs). Yet, raw time-series CPET recordings may hold additional information with clinical relevance. Therefore, we investigated whether analysis of raw CPET data using dynamic time warping combined with k-medoids could identify distinct CRF phenogroups and improve cardiovascular (CV) risk stratification. CPET recordings from 1,399 participants (mean age, 56.4 years; 37.7% women) were separated into 5 groups with distinct patterns. Cluster 5 was associated with the worst CV profile with higher use of antihypertensive medication and a history of CV disease, while cluster 1 represented the most favorable CV profile. Clusters 4 (hazard ratio: 1.30; p = 0.033) and 5 (hazard ratio: 1.36; p = 0.0088) had a significantly higher risk of incident adverse events compared to clusters 1 and 2. The model evaluation in the external validation cohort revealed similar patterns. Therefore, an integrative CRF profiling might facilitate CV risk stratification and management.

Cardiorespiratory fitness components in relation to clinical characteristics, disease state and medication intake: A patient registry study.

BACKGROUND: Interpretation of cardiopulmonary exercise testing (CPET) results requires thorough understanding of test confounders such as anthropometrics, comorbidities and medication. Here, we comprehensively assessed the clinical determinants of cardiorespiratory fitness and its components in a heterogeneous patient sample. METHODS: We retrospectively collected medical and CPET data from 2320 patients (48.2% females) referred for cycle ergometry at the University Hospital Leuven, Belgium. We assessed clinical determinants of peak CPET indexes of cardiorespiratory fitness (CRF) and its hemodynamic and ventilatory components using stepwise regression and quantified multivariable-adjusted differences in indexes between cases and references. RESULTS: Lower peak load and peak O2 uptake were related to: higher age, female sex, lower body height and weight, and higher heart rate; to the intake of beta blockers, analgesics, thyroid hormone replacement and benzodiazepines; and to diabetes mellitus, chronic kidney disease, non-ST elevation myocardial infarction and atrial fibrillation (p < 0.05 for all). Lower peak load also correlated with obstructive pulmonary diseases. Stepwise regression revealed associations of hemodynamic and ventilatory indexes (including heart rate, O2 pulse, systolic blood pressure and ventilation at peak exercise and ventilatory efficiency) with age, sex, body composition and aforementioned diseases and medications. Multivariable-adjusted differences in CPET metrics between cases and controls confirmed the associations observed. CONCLUSION: We described known and novel associations of CRF components with demographics, anthropometrics, cardiometabolic and pulmonary diseases and medication intake in a large patient sample. The clinical implications of long-term noncardiovascular drug intake for CPET results require further investigation.

Personalized remotely guided preventive exercise therapy for a healthy heart (PRIORITY): protocol for an assessor-blinded, multicenter randomized controlled trial.

Aims: A key treatment for patients with varying stages of heart failure with preserved ejection fraction (HFpEF) is exercise. Yet, despite a Class 1A recommendation, only one-third of patients exercise sufficiently. A huge treatment gap exists between guidelines and clinical practice. PRIORITY aims to establish the feasibility, clinical effectiveness and cost-effectiveness of a hybrid centre and home-based personalized exercise and physical activity intervention for patients along the HFpEF continuum. Methods: An assessor-blinded, multicenter randomized controlled trial will be conducted among 312 patients along the HFpEF continuum. Participants will be randomized (1:1) to the PRIORITY intervention or a comparator group receiving only a written exercise prescription. Participants in the PRIORITY group will receive 18 supervised centre-based exercise sessions during one year, supplemented with a remotely guided home-based physical activity program. Outcomes will be assessed at baseline, 4 months, one and two years. The primary outcome is the peak oxygen uptake (pVO2) at 1-year. Secondary outcomes include physical activity, other physical fitness parameters, cardiovascular health, echocardiographic parameters, health-related quality of life and costs at 1-year FU. Machine learning algorithms will analyse big data on physical activity collected during the 1-year intervention to develop models that can predict physical activity uptake and adherence as well as changes in fitness and health. A cost-utility analysis will be performed to evaluate the cost-effectiveness of the PRIORITY intervention compared to the control condition. Discussion: We anticipate that participants in the supervised home-based exercise intervention group will have a greater increase in pVO2 compared to those receiving a written exercise prescription. Trial registration number: This trial is registered at ClinicalTrials.gov (NCT04745013) and is currently in the recruitment stage.

Integrative Interpretation of Cardiopulmonary Exercise Tests for Cardiovascular Outcome Prediction: A Machine Learning Approach.

Integrative interpretation of cardiopulmonary exercise tests (CPETs) may improve assessment of cardiovascular (CV) risk. Here, we identified patient phenogroups based on CPET summary metrics and evaluated their predictive value for CV events. We included 2280 patients with diverse CV risk who underwent maximal CPET by cycle ergometry. Key CPET indices and information on incident CV events (median follow-up time: 5.3 years) were derived. Next, we applied unsupervised clustering by Gaussian Mixture modeling to subdivide the cohort into four male and four female phenogroups solely based on differences in CPET metrics. Ten of 18 CPET metrics were used for clustering as eight were removed due to high collinearity. In males and females, the phenogroups differed significantly in age, BMI, blood pressure, disease prevalence, medication intake and spirometry. In males, phenogroups 3 and 4 presented a significantly higher risk for incident CV events than phenogroup 1 (multivariable-adjusted hazard ratio: 1.51 and 2.19; p ≤ 0.048). In females, differences in the risk for future CV events between the phenogroups were not significant after adjustment for clinical covariables. Integrative CPET-based phenogrouping, thus, adequately stratified male patients according to CV risk. CPET phenomapping may facilitate comprehensive evaluation of CPET results and steer CV risk stratification and management.

Satisfaction and Acceptability of Telemonitored Home-Based Exercise in Patients With Intermittent Claudication: Pragmatic Observational Pilot Study.

BACKGROUND: Current guidelines recommend supervised exercise training (SET) as a first-line treatment in patients with intermittent claudication (IC). SET has been shown to be more effective than home-based exercise therapy (HBET). However, the lack of available SET programs hampers broad SET implementation in clinical practice. OBJECTIVE: The aim of this study is to assess patient satisfaction and acceptability of a structured HBET program using wearable technology and elastic band resistance exercises. METHODS: A total of 20 patients with IC (Rutherford 1-3) with internet access and currently not engaged in structured exercise training were recruited in a pragmatic observational pilot study. Participants were instructed to complete 3 walking sessions and 2 elastic band resistance exercise sessions per week in their home environment during a 4-week period. Patient satisfaction and acceptability were assessed using a 5-point Likert scale questionnaire (1-2=very unsatisfied, 3=neutral, and 4-5=very satisfied) evaluating the materials and intervention content. Secondary outcomes were evaluated at baseline and at completion of the 4-week intervention and included maximal walking distance (MWD) and pain-free walking distance (PFWD), physical fitness, and patient-reported outcomes on quality of life, walking capacity, levels of kinesiophobia, and self-efficacy. Statistically significant changes were tested using paired t tests or Wilcoxon signed-rank tests. RESULTS: All patients (15 men, 5 women; mean age 64.6, SD 10.6 years; range 41-81 years) completed the 4-week intervention and were highly satisfied with the program (mean overall score 4.5, SD 0.5). Patients' questionnaire responses documented willingness to recommend the exercise program to other patients (mean 4.5, SD 0.5; median 4.5) and preference for continuing the intervention (mean 4.3, SD 0.5; median 4). Furthermore, participants endorsed the use of the sports watches to track walking sessions (mean 4.25, SD 0.6; median 4), felt safe (mean 4.4, SD 0.6; median 4), and appreciated personal feedback (mean 4.55, SD 0.5; median 5) and flexibility of training (mean 4.1, SD 0.7; median 4). Resistance training was not preferred over walking training (mean 2.65, SD 0.8; median 3). In addition, PFWD (+89 m; P=.001), MWD (+58 m; P=.03), Walking Impairment Questionnaire distance score (+0.18; P=.01), activity-related scores (+0.54; P<.001), and total quality of life (+0.36; P=.009) improved following the intervention. Other patient-related outcomes, physical fitness, and physical activity remained to be statistically unaltered. CONCLUSIONS: Patients with IC were satisfied and accepted technology to monitor and guide HBET, with observed short-term effectiveness regarding walking capacity and quality of life. However, elastic band resistance exercises as a part of HBET were not preferred over progressive walking. TRIAL REGISTRATION: ClinicalTrials.gov NCT04043546; https://clinicaltrials.gov/ct2/show/NCT04043546.

Home-based exercise with telemonitoring guidance in patients with coronary artery disease: Does it improve long-term physical fitness?

BACKGROUND: Home-based interventions might facilitate the lifelong uptake of a physically active lifestyle following completion of a supervised phase II exercise-based cardiac rehabilitation. Yet, data on the long-term effectiveness of home-based exercise training on physical activity and exercise capacity are scarce. OBJECTIVE: The purpose of the TeleRehabilitation in Coronary Heart disease (TRiCH) study was to compare the long-term effects of a short home-based phase III exercise programme with telemonitoring guidance to a prolonged centre-based phase III programme in coronary artery disease patients. The primary outcome was exercise capacity. Secondary outcomes included physical activity behaviour, cardiovascular risk profile and health-related quality of life. METHODS: Ninety coronary artery disease patients (80 men) were randomly assigned to 3 months of home-based (30), centre-based (30) or a control group (30) on a 1:1:1 basis after completion of their phase II ambulatory cardiac rehabilitation programme. Outcome measures were assessed at discharge of the phase II programme and after one year. RESULTS: Eighty patients (72 (91%) men; mean age 62.6 years) completed the one-year follow-up measurements. Exercise capacity and secondary outcomes were preserved in all three groups (Ptime > 0.05 for all), irrespective of the intervention (Pinteraction > 0.05 for all). Eighty-five per cent of patients met the international guidelines for physical activity (Ptime < 0.05). No interaction effect was found for physical activity. CONCLUSION: Overall, exercise capacity remained stable during one year following phase II cardiac rehabilitation. Our home-based exercise intervention was as effective as centre-based and did not result in higher levels of exercise capacity and physical activity compared to the other two interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02047942. https://clinicaltrials.gov/ct2/show/NCT02047942.

A qualitative exploration of cardiovascular disease patients' views and experiences with an eHealth cardiac rehabilitation intervention: The PATHway Project.

The aim of this study is to explore participants' views and experiences of an eHealth phase 3 cardiac rehabilitation (CR) intervention: Physical Activity Towards Health (PATHway). Sixty participants took part in the PATHway intervention. Debriefs were conducted after the six-month intervention. All interviews were audio recorded and transcribed verbatim. Transcripts were analysed with Braun and Clarke's thematic analysis. Forty-four (71%) debriefs were conducted (n = 34 male, mean (SD) age 61 (10) years). Five key themes were identified: (1) Feedback on the components of the PATHway system, (2) Motivation, (3) Barriers to using PATHway, (4) Enablers to using PATHway, and (5) Post programme reflection. There were a number of subthemes within each theme, for example motivation explores participants motivation to take part in PATHway and participants motivation to sustain engagement with PATHway throughout the intervention period. Participant engagement with the components of the PATHway system was variable. Future research should focus on optimising participant familiarisation with eHealth systems and employ an iterative approach to development and evaluation.

The development and codesign of the PATHway intervention: a theory-driven eHealth platform for the self-management of cardiovascular disease.

Cardiovascular diseases (CVDs) are a leading cause of premature death worldwide. International guidelines recommend routine delivery of all phases of cardiac rehabilitation (CR). Uptake of traditional CR remains suboptimal, as attendance at formal hospital-based CR programs is low, with community-based CR rates and individual long-term exercise maintenance even lower. Home-based CR programs have been shown to be equally effective in clinical and health-related quality of life outcomes and yet are not readily available. The aim of the current study was to develop the PATHway intervention (physical activity toward health) for the self-management of CVD. Increasing physical activity in individuals with CVD was the primary behavior. The PATHway intervention was theoretically informed by the behavior change wheel and social cognitive theory. All relevant intervention functions, behavior change techniques, and policy categories were identified and translated into intervention content. Furthermore, a person-centered approach was adopted involving an iterative codesign process and extensive user testing. Education, enablement, modeling, persuasion, training, and social restructuring were selected as appropriate intervention functions. Twenty-two behavior change techniques, linked to the six intervention functions and three policy categories, were identified for inclusion and translated into PATHway intervention content. This paper details the use of the behavior change wheel and social cognitive theory to develop an eHealth intervention for the self-management of CVD. The systematic and transparent development of the PATHway intervention will facilitate the evaluation of intervention effectiveness and future replication.

Computerised decision support in physical activity interventions: A systematic literature review.

BACKGROUND: The benefits of regular physical activity for health and quality of life are unarguable. New information, sensing and communication technologies have the potential to play a critical role in computerised decision support and coaching for physical activity. OBJECTIVES: We provide a literature review of recent research in the development of physical activity interventions employing computerised decision support, their feasibility and effectiveness in healthy and diseased individuals, and map out challenges and future research directions. METHODS: We searched the bibliographic databases of PubMed and Scopus to identify physical activity interventions with computerised decision support utilised in a real-life context. Studies were synthesized according to the target user group, the technological format (e.g., web-based or mobile-based) and decision-support features of the intervention, the theoretical model for decision support in health behaviour change, the study design, the primary outcome, the number of participants and their engagement with the intervention, as well as the total follow-up duration. RESULTS: From the 24 studies included in the review, the highest percentage (n = 7, 29%) targeted sedentary healthy individuals followed by patients with prediabetes/diabetes (n = 4, 17%) or overweight individuals (n = 4, 17%). Most randomized controlled trials reported significantly positive effects of the interventions, i.e., increase in physical activity (n = 7, 100%) for 7 studies assessing physical activity measures, weight loss (n = 3, 75%) for 4 studies assessing diet, and reductions in glycosylated hemoglobin (n = 2, 66%) for 3 studies assessing glycose concentration. Accelerometers/pedometers were used in almost half of the studies (n = 11, 46%). Most adopted decision support features included personalised goal-setting (n = 16, 67%) and motivational feedback sent to the users (n = 15, 63%). Fewer adopted features were integration with electronic health records (n = 3, 13%) and alerts sent to caregivers (n = 4, 17%). Theoretical models of decision support in health behaviour to drive the development of the intervention were not reported in most studies (n = 14, 58%). CONCLUSIONS: Interventions employing computerised decision support have the potential to promote physical activity and result in health benefits for both diseased and healthy individuals, and help healthcare providers to monitor patients more closely. Objectively measured activity through sensing devices, integration with clinical systems used by healthcare providers and theoretical frameworks for health behaviour change need to be employed in a larger scale in future studies in order to realise the development of evidence-based computerised systems for physical activity monitoring and coaching.

Computerized decision support for beneficial home-based exercise rehabilitation in patients with cardiovascular disease.

BACKGROUND: Exercise-based rehabilitation plays a key role in improving the health and quality of life of patients with Cardiovascular Disease (CVD). Home-based computer-assisted rehabilitation programs have the potential to facilitate and support physical activity interventions and improve health outcomes. OBJECTIVES: We present the development and evaluation of a computerized Decision Support System (DSS) for unsupervised exercise rehabilitation at home, aiming to show the feasibility and potential of such systems toward maximizing the benefits of rehabilitation programs. METHODS: The development of the DSS was based on rules encapsulating the logic according to which an exercise program can be executed beneficially according to international guidelines and expert knowledge. The DSS considered data from a prescribed exercise program, heart rate from a wristband device, and motion accuracy from a depth camera, and subsequently generated personalized, performance-driven adaptations to the exercise program. Communication interfaces in the form of RESTful web service operations were developed enabling interoperation with other computer systems. RESULTS: The DSS was deployed in a computer-assisted platform for exercise-based cardiac rehabilitation at home, and it was evaluated in simulation and real-world studies with CVD patients. The simulation study based on data provided from 10 CVD patients performing 45 exercise sessions in total, showed that patients can be trained within or above their beneficial HR zones for 67.1 ±â€¯22.1% of the exercise duration in the main phase, when they are guided with the DSS. The real-world study with 3 CVD patients performing 43 exercise sessions through the computer-assisted platform, showed that patients can be trained within or above their beneficial heart rate zones for 87.9 ±â€¯8.0% of the exercise duration in the main phase, with DSS guidance. CONCLUSIONS: Computerized decision support systems can guide patients to the beneficial execution of their exercise-based rehabilitation program, and they are feasible.

Longer-term effects of home-based exercise interventions on exercise capacity and physical activity in coronary artery disease patients: A systematic review and meta-analysis.

Background Exercise-based cardiovascular rehabilitation (CR) improves exercise capacity (EC), lowers cardiovascular risk profile and increases physical functioning in the short term. However, uptake of and adherence to a physically active lifestyle in the long run remain problematic. Home-based (HB) exercise programmes have been introduced in an attempt to enhance long-term adherence to recommended levels of physical activity (PA). The current systematic review and meta-analysis aimed to compare the longer-term effects of HB exercise programmes with usual care (UC) or centre-based (CB) CR in patients referred for CR. Design Systematic review and meta-analysis. Methods Non-randomised controlled trials (RCTs) or randomised trials comparing the effects of HB exercise programmes with UC or CB rehabilitation on EC and/or PA, with a follow-up period of ≥12 months and performed in coronary artery disease patients, were searched in four databases (PubMed, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Cochrane Central Register of Controlled trials (CENTRAL)) from their inception until September 7, 2016. Standardised mean differences (SMDs) were calculated and pooled by means of random effects models. Risk of bias, publication bias and heterogeneity among trials were also assessed. Results Seven studies could be included in the meta-analysis on EC, but only two studies could be included in the meta-analysis on PA (total number of 1440 patients). The results showed no significant differences in EC between HB rehabilitation and UC (SMD 0.10, 95% confidence interval (CI) -0.13 to 0.33). There was a small but significant difference in EC in favour of HB compared to CB rehabilitation (SMD 0.25, 95% CI 0.02-0.48). No differences were found for PA (SMD 0.37, 95% CI -0.18 to 0.92). Conclusions HB exercise is slightly more effective than CB rehabilitation in terms of maintaining EC. The small number of studies warrants the need for more RCTs evaluating the long-term effects of different CR interventions on EC and PA behaviour, as this is the ultimate goal of CR.

Validity of heart rate measurements by the Garmin Forerunner 225 at different walking intensities.

The accuracy of wrist worn heart rate monitors based on photoplethysmography (PPG) is not fully clinically accepted. Therefore, we aimed to validate heart rate measurements of a commercially available PPG heart rate monitor, i.e. the Garmin Forerunner® 225. Twelve healthy volunteers (six women; mean age: 28 years) performed a treadmill protocol consisting of: five minutes sitting, five minutes standing, 10 minutes walking at 4 km/h, 10 minutes walking at a gradient of 5% and intensity of 4-6 metabolic equivalents (METs), 10 minutes walking at a gradient of 8% and intensity of seven METs or more. Walking speeds were individually determined. Walking bouts were separated by a standardised five minute rest period. Heart rate was measured as the average of the last three minutes standing and of each walking bout. A three lead patch-based electrocardiogram (ECG; Zensor®) was used as criterion method. Statistical analyses included Pearson's correlation (r), paired t-tests, root mean squared error (RMSE) and Bland?Altman plots. The mean values per three minutes of every condition did not differ significantly between the Garmin Forerunner® 225 and the Zensor®. RMSE was 3.01 beats per minute (bpm) or 2.89%. The Bland-Altman bias was 1.57 bpm. Limits of agreement (LoA) were wide, ranging from 32.53 to 29.40 bpm. However, Pearson's r ranged from 0.650 to 0.868 suggesting moderate to strong validity. Generally, mean heart rates, r values, RMSE and the Bland-Altman bias indicated good overall agreement in this sample of healthy adults, but wide LoA are making it difficult to trust individual measurements.