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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. ispartof: DIAGNOSTICS vol:13 issue:12 ispartof: location:Switzerland status: published

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. ispartof: JOURNAL OF MEDICAL INTERNET RESEARCH vol:22 issue:2 ispartof: location:Canada status: published

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 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

Background Cardiovascular diseases (CVD) are a leading cause of premature death and disability and an economic burden worldwide. International guidelines recommend routine availability and delivery of all phases of cardiac rehabilitation (CR). Uptake of traditional cardiac rehabilitation remains suboptimal, as attendance at formal hospital-based CR programmes 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. Purpose The aim of the current study was to develop the PATHway intervention (Physical Activity Towards Health) for the self-management of cardiovascular disease. Increasing physical activity in individuals with CVD was the primary behaviour. Methods The PATHway intervention was theoretically informed by the Behaviour Change Wheel (BCW) and Social Cognitive Theory (SCT). All relevant intervention functions, behaviour change techniques (BCTs) and policy categories were identified and translated into intervention content. Furthermore, a person-centred approach was adopted involving an iterative co-design process and extensive user-testing. Results Education, enablement, modelling, persuasion, training and social restructuring were selected as appropriate intervention functions. Twenty-two BCTs, linked to the 6 intervention functions and 3 policy categories were identified for inclusion and translated into PATHway intervention content. Conclusions This paper details the use of the BCW and SCT within a person-centred framework 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. The Template for Intervention Description and Replication (TIDieR) checklist was used to specify details of the intervention including the who, what, how and where of proposed intervention delivery.

Purpose: Cardiovascular disease (CVD) is the leading cause of premature death and disability in Europe. Effective exercise-based cardiac rehabilitation (CR) can improve mortality and morbidity rates, yet uptake of community-based CR is low (1). PATHway (Physical Activity Towards Health) is a technology-enabled lifestyle behaviour change intervention designed to enhance patient self-management of CVD through adherence to physical activity and other health behaviours. This paper explains the co-design and user validation process that is being employed for the development of the PATHway platform. Methods: CVD patients from a) hospital-based CR and b) community-based CR across two sites (Dublin, Ireland; Leuven, Belgium) are invited to participate in the study. To facilitate an iterative process, three separate rounds of semi-structured interviews, a total of twelve focus groups (4 groups x 3 rounds) are planned between February and April 2016. In round one interviews, participants were exposed to the PATHway intervention and system designed by the research team, and feedback was elicited. Interviews were audio-recorded, transcribedand content analysed. Key recommendations regarding technical and intervention content were identified and are currently being used by the research team to improve the PATHway system. Completion of the interviews is due for April 2016 Results: Round one data indicated that i) tailoring intervention content for exercise prescription and health behaviour change was important; ii) further health information and monitoring through the system was valuable, and iii) the potential for patients to be connected with their healthcare professionals was appealing. Technical recommendations included amending the avatar display to reflect an average BMI and be ‘more human-like’. Additional behaviour change recommendations included stressing the importance of positive reinforcement even when a participant is not meeting set goals. Conclusions: An iterative co-design and user validation process can be a vital component of the development of complex behavioural interventions for CVD patients. This project has received funding from the European Union’s Horizon 2020 Framework Programme for Research and Innovation Action under Grant Agreement no. 643491. PATHway: Technology enabled behavioural change as a pathway towards better self-management of CVD (www.pathway2health.eu)

Background Exercise-based cardiac rehabilitation (CR) favorable and independently alters the clinical course of cardiovascular diseases resulting in a significant reduction in all-cause and cardiac mortality. However, only 15-30% of all eligible patients participate in a phase 2 ambulatory program. Uptake rates of community based programs following phase 2 CR are even lower and adherence to long-term CR is extremely poor. Newer care models, involving programs that are delivered remotely such as telehealth programs, show considerable promise for increasing adherence. In this view, PATHway (Physical Activity Towards Health) is being developed and needs to be evaluated on feasibility and potential clinical benefit. Methods In a multicentre randomized controlled pilot trial, 120 patients (m/f, age 40-80yrs) completing a phase 2 ambulatory CR program will be randomized on a 1:1 basis to PATHway or usual care. PATHway involves a complex comprehensive, internet-enabled, sensor-based home CR platform. It consists of several modules with an exercise module as the core component. PATHway provides individualized heart rate monitored exercise programs (exerclasses and exergames) as the basis upon which to provide additionally a personalized, comprehensive lifestyle intervention program (managing exercise, smoking, diet, stress, alcohol use). The control group will receive normal care. Study outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is the change in active energy expenditure. Secondary outcomes include health-related fitness (cardiopulmonary endurance capacity, muscle strength, body composition), vascular health (vascular stiffness and endothelial function), cardiovascular risk score, health-related quality of life, patient satisfaction, healthcare costs and safety. Intervention feasibility will be assessed via participant and stakeholder debrief. Discussion This study investigates the feasibility of the PATHway system in supporting patients to maintain a physically active lifestyle, and investigates its short-term effectiveness on cardiovascular health. It has the potential to further extend the provision of poorly accessible, hospital-based rehabilitation programs to effective, cost-effective delivery models in the community. This project has received funding from the European Union’s Horizon 2020 Framework Programme for Research and Innovation Action under Grant Agreement no.643491. PATHway: Technology enabled behavioural change as a pathway towards better self-management of CVD (www.pathway2health.eu/).