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

Jomme Claes, Véronique Cornelissen, Clare McDermott, Niall Moyna, Nele Pattyn, Nils Cornelis, Anne Gallagher, Ciara McCormack, Helen Newton, Alexandra Gillain, Werner Budts, Kaatje Goetschalckx, Catherine Woods, Kieran Moran, Roselien Buys, Jomme Claes, Véronique Cornelissen, Clare McDermott, Niall Moyna, Nele Pattyn, Nils Cornelis, Anne Gallagher, Ciara McCormack, Helen Newton, Alexandra Gillain, Werner Budts, Kaatje Goetschalckx, Catherine Woods, Kieran Moran, Roselien Buys

Abstract

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://ichgcp.net/clinical-trials-registry/NCT02717806.

International registered report identifier (irrid): RR2-10.1136/bmjopen-2017-016781.

Keywords: cardiac rehabilitation; eHealth; physical activity; technology.

Conflict of interest statement

Conflicts of Interest: None declared.

©Jomme Claes, Véronique Cornelissen, Clare McDermott, Niall Moyna, Nele Pattyn, Nils Cornelis, Anne Gallagher, Ciara McCormack, Helen Newton, Alexandra Gillain, Werner Budts, Kaatje Goetschalckx, Catherine Woods, Kieran Moran, Roselien Buys. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 04.02.2020.

Figures

Figure 1
Figure 1
Study flow. CR: cardiac rehabilitation; FAQ: frequently asked questions.
Figure 2
Figure 2
CONSORT (Consolidated Standards of Reporting Trials) flowchart. AE: adverse event; 3mFU: 3-month follow-up; 6mFU: 6-month follow-up; SAE: serious adverse event.
Figure 3
Figure 3
Evolution of moderate-to-vigorous physical activity per day over time in minutes. 6mFU: 6-month follow-up.
Figure 4
Figure 4
Exploratory analysis of significant correlation coefficients between Physical Activity Toward Health use and demographics, physical activity, and physical fitness. diff: difference; EE: energy expenditure; HRVAT: heart rate at the first ventilatory threshold; MVPA: moderate-to-vigorous physical activity; pHR: peak heart rate; pLoad: peak load; pRER: peak respiratory exchange ratio; pSBP: peak systolic blood pressure; percentVO2VAT: percent oxygen uptake at first ventilatory threshold; predicted_VO2: predicted oxygen uptake according to Hansen; pVE: peak ventilation; pVO2: peak oxygen consumption; VO2VAT: oxygen uptake at first ventilatory threshold; WVAT: load at first ventilatory threshold; Sed: sedentary time.
Figure 5
Figure 5
Average amount of exercise sessions per week using the Physical Activity Toward Health system.
Figure 6
Figure 6
Overview of adverse events during the trial. AE: adverse events; CABG: coronary artery bypass grafting; HF: heart failure; PCI: percutaneous coronary intervention; SAE: serious adverse events.

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