Efficacy, efficiency and safety of a cardiac telerehabilitation
programme using wearable sensors in patients with coronary
heart disease: the TELEWEAR-CR study protocol

J 2022

Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol

ANTONIOU, V., A. XANTHOPOULOS, G. GIAMOUZIS, C. DAVOS, Ladislav BAŤALÍK et. al.

Basic information

Original name

Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol

Authors

ANTONIOU, V., A. XANTHOPOULOS, G. GIAMOUZIS, C. DAVOS, Ladislav BAŤALÍK (203 Czech Republic, belonging to the institution), V. STAVROU, K. I. GOURGOULIANIS, E. KAPRELI, J. SKOULARIGIS and G. PEPERA (guarantor)

Edition

BMJ Open, London, BMJ Publishing Group, 2022, 2044-6055

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30218 General and internal medicine

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 2.900

RIV identification code

RIV/00216224:14110/22:00126217

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1136/bmjopen-2021-059945

UT WoS

000817900500010

Keywords in English

cardiac telerehabilitation; wearable sensors; coronary heart disease

Abstract

V originále

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 20min 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.

Citovat

ANTONIOU, V., A. XANTHOPOULOS, G. GIAMOUZIS, C. DAVOS, Ladislav BAŤALÍK, V. STAVROU, K. I. GOURGOULIANIS, E. KAPRELI, J. SKOULARIGIS and G. PEPERA. 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. London: BMJ Publishing Group, 2022, vol. 12, No 6, p. 1-10. ISSN 2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2021-059945.

@article{1874118,
   author = {Antoniou, V. and Xanthopoulos, A. and Giamouzis, G. and Davos, C. and Baťalík, Ladislav and Stavrou, V. and Gourgoulianis, K. I. and Kapreli, E. and Skoularigis, J. and Pepera, G.},
   article_location = {London},
   article_number = {6},
   doi = {http://dx.doi.org/10.1136/bmjopen-2021-059945},
   keywords = {cardiac telerehabilitation; wearable sensors; coronary heart disease},
   language = {eng},
   issn = {2044-6055},
   journal = {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},
   url = {https://bmjopen.bmj.com/content/12/6/e059945},
   volume = {12},
   year = {2022}
}

TY  - JOUR
ID  - 1874118
AU  - Antoniou, V. - Xanthopoulos, A. - Giamouzis, G. - Davos, C. - Baťalík, Ladislav - Stavrou, V. - Gourgoulianis, K. I. - Kapreli, E. - Skoularigis, J. - Pepera, G.
PY  - 2022
TI  - Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol
JF  - BMJ Open
VL  - 12
IS  - 6
SP  - 1-10
EP  - 1-10
PB  - BMJ Publishing Group
SN  - 20446055
KW  - cardiac telerehabilitation
KW  - wearable sensors
KW  - coronary heart disease
UR  - https://bmjopen.bmj.com/content/12/6/e059945
N2  - 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 20min 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.
ER  -

ANTONIOU, V., A. XANTHOPOULOS, G. GIAMOUZIS, C. DAVOS, Ladislav BAŤALÍK, V. STAVROU, K. I. GOURGOULIANIS, E. KAPRELI, J. SKOULARIGIS and G. PEPERA. Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol. \textit{BMJ Open}. London: BMJ Publishing Group, 2022, vol.~12, No~6, p.~1-10. ISSN~2044-6055. Available from: https://dx.doi.org/10.1136/bmjopen-2021-059945.

Detailed Information on Publication Record