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Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial

INTRODUCTION: Premenopausal and postmenopausal osteoporosis and associated fragility fractures are major public health problems. Exercise, especially moderate-to-high-intensity impact exercise, has been recommended as an effective, low-cost non-pharmacological strategy for bone strength improvement;...

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Autores principales: Li, Simin, Li, Yi, Liang, Qiu, Yang, Wen-Jie, Zi, Rui, Wu, Xuyi, Du, Chunping, Jiang, Yan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644343/
https://www.ncbi.nlm.nih.gov/pubmed/36344002
http://dx.doi.org/10.1136/bmjopen-2022-064328
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author Li, Simin
Li, Yi
Liang, Qiu
Yang, Wen-Jie
Zi, Rui
Wu, Xuyi
Du, Chunping
Jiang, Yan
author_facet Li, Simin
Li, Yi
Liang, Qiu
Yang, Wen-Jie
Zi, Rui
Wu, Xuyi
Du, Chunping
Jiang, Yan
author_sort Li, Simin
collection PubMed
description INTRODUCTION: Premenopausal and postmenopausal osteoporosis and associated fragility fractures are major public health problems. Exercise, especially moderate-to-high-intensity impact exercise, has been recommended as an effective, low-cost non-pharmacological strategy for bone strength improvement; however, evidence on fracture risk is limited. In addition, maintaining regular training is currently a problem. Therefore, this study aims to conduct a randomised controlled trial of moderate-to-high-intensity tele-exercise intervention using a tele-rehabilitation app and quantify its effects on vertical fracture and fall prevention in women at high risk of osteoporotic fractures. METHODS AND ANALYSIS: In this multicentre, randomised controlled trial, 794 women at high risk of osteoporotic fractures will be recruited and randomised into either the tele-exercise rehabilitation or control group. Participants in the control group will receive routine remote rehabilitation, while those in the intervention group will be provided with a 6-month tele-exercise rehabilitation. The primary outcomes are the percentage of participants with one or more new vertebral fractures and incidence of falls. Intention-to-treat, full analysis set and per-protocol approaches will be used for outcome analyses. ETHICS AND DISSEMINATION: The study was approved by the biomedical research ethics committee of the West China Hospital of Sichuan University (2021-579). Written informed consent will be obtained from each participant after agreeing to participate in the study. The study findings will be presented at national and international scientific conferences and published in peer-reviewed journals. Results are propagated regardless of the magnitude or direction of the impact. Authorship is assigned according to authorship guidelines as defined by the International Board of Medical Journal Editors, and each author’s role is based on journal requirements for publication. TRIAL REGISTRATION NUMBER: The study was registered with the Chinese Clinical Trial Registry (ChiCTR2200058780) prior to recruitment (May 2022).
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spelling pubmed-96443432022-11-15 Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial Li, Simin Li, Yi Liang, Qiu Yang, Wen-Jie Zi, Rui Wu, Xuyi Du, Chunping Jiang, Yan BMJ Open Rehabilitation Medicine INTRODUCTION: Premenopausal and postmenopausal osteoporosis and associated fragility fractures are major public health problems. Exercise, especially moderate-to-high-intensity impact exercise, has been recommended as an effective, low-cost non-pharmacological strategy for bone strength improvement; however, evidence on fracture risk is limited. In addition, maintaining regular training is currently a problem. Therefore, this study aims to conduct a randomised controlled trial of moderate-to-high-intensity tele-exercise intervention using a tele-rehabilitation app and quantify its effects on vertical fracture and fall prevention in women at high risk of osteoporotic fractures. METHODS AND ANALYSIS: In this multicentre, randomised controlled trial, 794 women at high risk of osteoporotic fractures will be recruited and randomised into either the tele-exercise rehabilitation or control group. Participants in the control group will receive routine remote rehabilitation, while those in the intervention group will be provided with a 6-month tele-exercise rehabilitation. The primary outcomes are the percentage of participants with one or more new vertebral fractures and incidence of falls. Intention-to-treat, full analysis set and per-protocol approaches will be used for outcome analyses. ETHICS AND DISSEMINATION: The study was approved by the biomedical research ethics committee of the West China Hospital of Sichuan University (2021-579). Written informed consent will be obtained from each participant after agreeing to participate in the study. The study findings will be presented at national and international scientific conferences and published in peer-reviewed journals. Results are propagated regardless of the magnitude or direction of the impact. Authorship is assigned according to authorship guidelines as defined by the International Board of Medical Journal Editors, and each author’s role is based on journal requirements for publication. TRIAL REGISTRATION NUMBER: The study was registered with the Chinese Clinical Trial Registry (ChiCTR2200058780) prior to recruitment (May 2022). BMJ Publishing Group 2022-11-07 /pmc/articles/PMC9644343/ /pubmed/36344002 http://dx.doi.org/10.1136/bmjopen-2022-064328 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Rehabilitation Medicine
Li, Simin
Li, Yi
Liang, Qiu
Yang, Wen-Jie
Zi, Rui
Wu, Xuyi
Du, Chunping
Jiang, Yan
Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial
title Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial
title_full Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial
title_fullStr Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial
title_full_unstemmed Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial
title_short Effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial
title_sort effects of tele-exercise rehabilitation intervention on women at high risk of osteoporotic fractures: study protocol for a randomised controlled trial
topic Rehabilitation Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644343/
https://www.ncbi.nlm.nih.gov/pubmed/36344002
http://dx.doi.org/10.1136/bmjopen-2022-064328
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