Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol
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 stu...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e059945.full |
| _version_ | 1826852956427780096 |
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| author | Andrew Xanthopoulos Eleni Kapreli Garyfallia Pepera Konstantinos I Gourgoulianis Varsamo Antoniou Gregory Giamouzis Constantinos Davos Ladislav Batalik Vasileios Stavrou John Skoularigis |
| author_facet | Andrew Xanthopoulos Eleni Kapreli Garyfallia Pepera Konstantinos I Gourgoulianis Varsamo Antoniou Gregory Giamouzis Constantinos Davos Ladislav Batalik Vasileios Stavrou John Skoularigis |
| author_sort | Andrew Xanthopoulos |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T07:08:49Z |
| format | Article |
| id | doaj.art-5bf1990dd18240b09012856813757d71 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-02-16T17:18:06Z |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-5bf1990dd18240b09012856813757d712025-01-28T01:55:08ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-059945Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocolAndrew Xanthopoulos0Eleni Kapreli1Garyfallia Pepera2Konstantinos I Gourgoulianis3Varsamo Antoniou4Gregory Giamouzis5Constantinos Davos6Ladislav Batalik7Vasileios Stavrou8John Skoularigis9Cardiology, University of Thessaly Faculty of Medicine, Larissa, GreeceClinical Exercise Physiology and Rehabilitation Research Laboratory, Physiotherapy Department, University of Thessaly School of Health Sciences, Lamia, GreeceClinical Exercise Physiology and Rehabilitation Research Laboratory, Physiotherapy Department, University of Thessaly School of Health Sciences, Lamia, GreeceLaboratory of Cardio-Pulmonary Testing, Department of Respiratory Medicine, University of Thessaly Faculty of Medicine, Larissa, GreeceClinical Exercise Physiology and Rehabilitation Research Laboratory, Physiotherapy Department, University of Thessaly School of Health Sciences, Lamia, GreeceCardiology, University of Thessaly Faculty of Medicine, Larissa, GreeceCardiovascular Research, Biomedical Research Foundation of the Academy of Athens, Athens, GreeceDepartment of Physiotherapy and Rehabilitation, Faculty of Medicine, Masaryk University, Brno, Czech RepublicLaboratory of Cardio-Pulmonary Testing, Department of Respiratory Medicine, University of Thessaly Faculty of Medicine, Larissa, GreeceCardiology, University of Thessaly Faculty of Medicine, Larissa, GreeceIntroduction 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.https://bmjopen.bmj.com/content/12/6/e059945.full |
| spellingShingle | Andrew Xanthopoulos Eleni Kapreli Garyfallia Pepera Konstantinos I Gourgoulianis Varsamo Antoniou Gregory Giamouzis Constantinos Davos Ladislav Batalik Vasileios Stavrou John Skoularigis Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol BMJ Open |
| title | Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol |
| title_full | Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol |
| title_fullStr | Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol |
| title_full_unstemmed | Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol |
| title_short | Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol |
| title_sort | efficacy efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease the telewear cr study protocol |
| url | https://bmjopen.bmj.com/content/12/6/e059945.full |
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