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

Abstract

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. 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. 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. The study was registered with the Chinese Clinical Trial Registry (ChiCTR2200058780) prior to recruitment (May 2022).