Effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic heart disease at moderate cardiovascular risk: A randomised, controlled clinical trial

Abstract

BackgroundPrevious studies have documented the feasibility of home-based cardiac rehabilitation programmes in low-risk patients with ischemic heart disease, but a similar solution needs to be found for patients at moderate cardiovascular risk. The objective of this study was to analyse the effectiveness and safety of a home-based cardiac rehabilitation programme of mixed surveillance in patients with ischemic cardiopathology at moderate cardiovascular risk.MethodsA randomised, controlled clinical trial was designed wherein 28 patients with stable coronary artery disease at moderate cardiovascular risk, who met the selection criteria for this study, participated. Of these, 14 were assigned to the group undergoing traditional cardiac rehabilitation in hospital (control group) and 14 were assigned to the home-based mixed surveillance programme (experimental group). The patients in the experimental group went to the cardiac rehabilitation unit once a week and exercised at home, which was monitored with a remote electrocardiographic monitoring device (NUUBO®). The in-home exercises comprised of walking at 70% of heart rate reserve during the first month, and 80% during the second month, for 1 h per day at a frequency of 5 to 7 days per week. A two-way repeated measures analysis of variance (ANOVA) was performed to evaluate the effects of time (before and after intervention) and time-group interaction regarding exercise capacity, risk profile, cardiovascular complications, and quality of life.ResultsNo significant differences were observed between the traditional cardiac rehabilitation group and the home-based with mixed surveillance group for exercise time and METS achieved during the exertion test, and the recovery rate in the first minute (which increased in both groups after the intervention). The only difference between the two groups was for quality of life scores (10.93 [IC95%: 17.251, 3.334, p = 0.007] vs −4.314 [IC95%: −11.414, 2.787; p = 0.206]). No serious heart-related complications were recorded during the cardiac rehabilitation programme.ConclusionsThe home-based cardiac rehabilitation programme with mixed surveillance appears to be as effective and safe as the traditional model in patients with ischemic heart disease who are at moderate cardiovascular risk. However, the cardiac rehabilitation programmes carried out in hospital seems to have better results in improving the quality of life.Trial registrationRetrospectively registered NCT02796404 (May 23, 2016).

Impact of cardiac rehabilitation and exercise training programs in coronary heart disease

“…In a cohort with ischemic CVD at moderate risk, one RCT found no significant differences between the traditional CR with mixed surveillance, and home-based tele-CR when it came to ET time, energy expenditure, and heart rate (HR) recovery in the first minute after exercise testing; however, HRQoL scores were higher in the conventional group. 30 Hwang et al enrolled 53 participants with HF into either home-based or conventional CR and found no significant difference with respect to the 6-minute-walk performance test. 31 Similarly, Moholdt and colleagues evaluated differences in oxygen (O2) uptake and HRQoL between facility-based and home-based CR and found no difference between groups in either O2 uptake and HRQoL.…”

Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study

“…The platform is Conformité Européenne certified as a medical device for use in the European Union. It has been tested in patients who have undergone an exercise echocardiography test [3] and cardiac rehabilitation [6].…”

“…Several reports have been published, in which wearable devices achieved very positive results with high diagnostic accuracy [3][4][5][6]. It was demonstrated that a garment-inserted electrocardiography (ECG) system can obtain similar results to those achieved with the conventional treadmill system during exercise testing,which may also include obtaining echocardiographic images [3].…”

“…Most importantly, the wearable system was invented to allow remote ECG monitoring during everyday activities. It was found useful in patients with coronary artery disease undergoing in-home cardiac rehabilitation [6]. Asimilar system (consisting of accelerometer and ECG) was also used to monitor heart rate and activities of rescuers (fire fighters and Civil Protection rescuers) during emergency interventions [4].…”

“…What is important, all wearable ECG systems presented to be comfortable during tests. This ensures an adequate level of adherence, mainly due to their non-invasive nature and non-interference with normal daily life activities [3][4][5][6].…”