Effects of a Behavior Change Wheel (BCW)-Based Resistance Exercise Program on Community-Dwelling Patients With Sarcopenia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Skeletal Muscle Mass Index
研究概览
简要总结
The purpose of this randomized controlled trial is to evaluate the effects of a Behavior Change Wheel (BCW)-based resistance exercise program on muscle health, physical performance, and exercise adherence in community-dwelling older adults with sarcopenia. Participants will be randomly assigned to either an experimental group or a waitlist control group. The experimental group will receive a 12-week BCW-based resistance exercise intervention (twice a week) immediately. The waitlist control group will maintain their usual routine for the first 3 months for comparison, and will then cross over to receive the identical 12-week intervention. The study aims to provide an effective and ethical exercise management strategy for sarcopenic patients.
详细描述
Sarcopenia is a progressive and generalized skeletal muscle disorder that significantly impairs physical function and quality of life in older adults. While resistance exercise is a well-established countermeasure, poor long-term exercise adherence remains a critical clinical barrier. To address this, the current study utilizes the Behavior Change Wheel (BCW) theory to construct a structured, theory-driven resistance exercise program aimed at enhancing both physiological health and behavioral compliance.
This study employs a randomized, waitlist-controlled trial design to ensure ethical equity, allowing all participants to eventually benefit from the intervention. Eligible community-dwelling older adults with sarcopenia will be randomly assigned to either an experimental group or a waitlist control group. The experimental group will immediately commence a 12-week BCW-based resistance exercise intervention (conducted twice weekly). The waitlist control group will undergo a 3-month observation period with their usual routine, after which they will cross over to receive the identical 12-week exercise program.
To comprehensively evaluate the efficacy of the intervention, primary and secondary outcomes-encompassing structural muscle health, physical performance, psychological indicators (e.g., self-efficacy, quality of life), and patient satisfaction-will be rigorously assessed at baseline, at 3 months, and post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors for physiological outcomes and questionnaires are blinded to group allocation.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for sarcopenia according to the Asian Working Group for Sarcopenia (AWGS) 2025:
- •Low muscle mass (SMI measured by BIA): For age ≥ 65, Male < 7.0 kg/m², Female < 5.7 kg/m²; For age 50-64, Male < 7.6 kg/m², Female < 5.7 kg/m².
- •Low muscle strength (Handgrip strength): For age ≥ 65, Male < 28 kg, Female < 18 kg; For age 50-64, Male < 34 kg, Female < 20 kg.
- •Ability to walk independently without assistive devices.
- •Clear consciousness and stable medical condition.
- •Willingness to participate, commit to the exercise protocol, and provide signed informed consent.
- •Proficiency in using a smartphone.
排除标准
- •Presence of metal implants, such as cardiac pacemakers, stents, steel plates, or artificial joints (due to BIA measurement constraints).
- •Cognitive impairment, epilepsy, other neurological disorders, or severe mental illness that prevents cooperation with the study.
- •Inability to complete the exercise intervention due to severe cardiovascular or musculoskeletal diseases.
- •Severe organ dysfunction (e.g., heart failure), organ failure, or active infection.
- •Inability to maintain adherence or significant missing data (participants who withdraw or are lost to follow-up).
研究组 & 干预措施
Waitlist Control Group
Participants will maintain their usual routine for the first 3 months. After the primary endpoint assessment at month 3, they will cross over to receive the identical 12-week resistance exercise program.
Resistance Training Group
Participants in this group will receive the BCW-based resistance exercise program immediately for 12 weeks (twice weekly).
干预措施: BCW-Based Resistance Exercise Program (Behavioral)
结局指标
主要结局
Skeletal Muscle Mass Index
时间窗: Baseline, 3 months, and 6 months
Skeletal muscle mass will be measured using Bioelectrical Impedance Analysis (BIA). SMI is calculated as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m²).
次要结局
- Handgrip Strength(Baseline, Month 3, and Month 6)
- 6-Meter Gait Speed(Baseline, Month 3, and Month 6)
- Self-Efficacy for Exercise Scale - Chinese Version (SEE-C) Score(Baseline, Month 3, and Month 6)
- Exercise Adherence Rate(Month 3 (Experimental Group) and Month 6 (Waitlist Group))
- Sarcopenia Quality of Life (SarQoL) Questionnaire Score(Baseline, Month 3, and Month 6)
- Participant satisfaction(Month 3 (Experimental Group) and Month 6 (Waitlist Group))
研究者
Bofeng Ye
Principal Investigator
Hangzhou Normal University