Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol
Language English Country Great Britain, England Media electronic
Document type Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't
PubMed
35738643
PubMed Central
PMC9226468
DOI
10.1136/bmjopen-2021-059945
PII: bmjopen-2021-059945
Knihovny.cz E-resources
- Keywords
- cardiology, rehabilitation medicine, telemedicine,
- MeSH
- Single-Blind Method MeSH
- Cardiac Rehabilitation * methods MeSH
- Coronary Disease * rehabilitation MeSH
- Quality of Life MeSH
- Humans MeSH
- Wearable Electronic Devices * MeSH
- Randomized Controlled Trials as Topic MeSH
- Telerehabilitation * methods MeSH
- Exercise Therapy methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Clinical Trial Protocol MeSH
INTRODUCTION: Exercise-based cardiac rehabilitation (CR) is a beneficial tool for the secondary prevention of cardiovascular diseases with, however, low participation rates. Telerehabilitation, intergrading mobile technologies and wireless sensors may advance the cardiac patients' adherence. This study will investigate the efficacy, efficiency, safety and cost-effectiveness of a telerehabilitation programme based on objective exercise telemonitoring and evaluation of cardiorespiratory fitness. METHODS AND ANALYSIS: A supervised, parallel-group, single-blind randomised controlled trial will be conducted. A total of 124 patients with coronary disease will be randomised in a 1:1 ratio into two groups: intervention telerehabilitation group (TELE-CR) (n=62) and control centre-based cardiac rehabilitation group (CB-CR) (n=62). Participants will receive a 12-week exercise-based rehabilitation programme, remotely monitored for the TELE-CR group and standard supervised for the CB-CR group. All participants will perform aerobic training at 70% of their maximal heart rate, as obtained from cardiopulmonary exercise testing (CPET) for 20 min plus 20 min for strengthening and balance training, three times per week. The primary outcomes will be the assessment of cardiorespiratory fitness, expressed as peak oxygen uptake assessed by the CPET test and the 6 min walk test. Secondary outcomes will be the physical activity, the safety of the exercise intervention (number of adverse events that may occur during the exercise), the quality of life, the training adherence, the anxiety and depression levels, the nicotine dependence and cost-effectiveness. Assessments will be held at baseline, end of intervention (12 weeks) and follow-up (36 weeks). ETHICS AND DISSEMINATION: The study protocol has been reviewed and approved by the Ethics Committee of the University of Thessaly (1108/1-12-2021) and by the Ethics Committee of the General University Hospital of Larissa (3780/31-01-2022). The results of this study will be disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05019157.
Cardiology University of Thessaly Faculty of Medicine Larissa Greece
Cardiovascular Research Biomedical Research Foundation of the Academy of Athens Athens Greece
Department of Public Health Masaryk University Brno Brno Czech Republic
Department of Rehabilitation University Hospital Brno Brno Czech Republic
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NCT05019157