Wang Wen-Xin, Qiu Ju, Kong Ling-Na, Yang Jun, Chen Lu, Zhao Yang, Wang Ting-Ting
School of Nursing, Chongqing Medical University, Chongqing, China.
Department of Breast and Thyroid Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
BMJ Open. 2025 Jun 30;15(6):e098945. doi: 10.1136/bmjopen-2025-098945.
Prefrailty is common among community-dwelling older adults with diabetes and can lead to adverse health outcomes. With effective exercise interventions, prefrailty is reversible. However, there is a paucity of evidence regarding the effects of exercise interventions for prefrail older adults with diabetes. This study presents a study protocol for evaluating the effectiveness of an exercise intervention based on the Capacity, Opportunity and Motivation Behaviour (COM-B) model among community-dwelling prefrail older adults with diabetes.
Using a randomised controlled trial design, a total of 100 community-dwelling prefrail older adults with diabetes will be allocated to either an intervention or a control group in a 1:1 ratio. Participants in the intervention group will receive a 16-week multicomponent exercise intervention based on the COM-B model, while those in the control group will receive usual diabetes care and general advice on physical activity. The primary outcome is frailty status, and the secondary outcomes include physical function, quality of life, depressive symptoms, self-efficacy for exercise and fasting blood glucose. Assessments will be conducted at baseline, week 8 and week 16.
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (approval number: K2023-320). The findings will be submitted to a peer-reviewed journal for publication.
ChiCTR2400082831.
糖尿病社区老年居民中衰弱前期很常见，且会导致不良健康后果。通过有效的运动干预，衰弱前期是可逆的。然而，关于运动干预对糖尿病衰弱前期老年患者影响的证据很少。本研究提出了一项研究方案，用于评估基于能力、机会和动机行为（COM-B）模型的运动干预对社区居住的糖尿病衰弱前期老年患者的有效性。
采用随机对照试验设计，总共100名社区居住的糖尿病衰弱前期老年患者将按1:1的比例分配到干预组或对照组。干预组的参与者将接受基于COM-B模型的为期16周的多组分运动干预，而对照组的参与者将接受常规糖尿病护理和关于体育活动的一般建议。主要结局是衰弱状态，次要结局包括身体功能、生活质量、抑郁症状、运动自我效能和空腹血糖。评估将在基线、第8周和第16周进行。
本研究已获得重庆医科大学附属第一医院伦理委员会批准（批准号：K2023-320）。研究结果将提交给同行评审期刊发表。
ChiCTR2400082831。
