Construction and Application of a Home-based Multicomponent Exercise Intervention Program for Older Adults With Osteosarcopenia Complicated by Frailty Based on the Fogg Behavior Model（FBM）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in frailty phenotype score at 6 months
研究概览
简要总结
This study aims to construct and evaluate a home-based multicomponent exercise intervention program based on the Fogg Behavior Model for older adults with osteosarcopenia and frailty. Eligible participants will be randomly divided into two groups. The intervention group will receive the home multicomponent exercise guidance built on Fogg Behavior Model, while the control group will get routine health education. We will compare frailty status, muscle strength, physical function,bone mineral density and quality of life between the two groups at baseline, 3 months and 6 months, to explore whether this intervention can improve physical function and reduce frailty in elderly patients with osteosarcopenia.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
盲法说明
Only outcome assessors are blinded to group allocation. Participants and care providers are aware of the assigned group due to the nature of home exercise intervention
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- The disease is in stable condition.
- Aged 60-85 years or older.
- Meet the diagnostic criteria in the 2022 Expert Consensus on Sarcopenia-Osteoporosis.
- The score of frailty scale is ≥1, indicating patients are in pre-frailty or frailty status.
- Clear consciousness, normal communication, capable of cooperating with exercise intervention; not living alone and will not leave the residence within half a year.
- Own a smartphone and voluntarily participate in this study.
排除标准
- Severe cardiopulmonary, hepatic or renal dysfunction.
- Uncontrolled severe neurological or psychiatric diseases.
- Recent fracture or unable to perform exercise training.
- Malignant tumor, severe infectious disease.
- Participate in other exercise intervention studies simultaneously.
- Cognitive impairment and cannot cooperate with follow-up.
研究组 & 干预措施
Intervention group
Home-based multi-component exercise intervention guided by Fogg Behavior Model, including resistance training, balance training and aerobic exercise for 6 months. Regular follow-up and behavior reminder will be provided.
干预措施: Multi-component home-based exercise intervention based on the Fogg Behavior Model (Behavioral)
Control group
Routine health education about osteoporosis and sarcopenia. No systematic supervised exercise intervention.
干预措施: routine health education and standard nursing care for osteoporosis and regular outpatient follow-up, without extra exercise and nutritional intervention. (Behavioral)
结局指标
主要结局
Change in frailty phenotype score at 6 months
时间窗: Baseline, 3 months, 6 months
The change of Fried frailty phenotype score from baseline to 6-month follow-up. Fried frailty scale ranges from 0 to 5, higher score means worse frailty status.
次要结局
- Change in handgrip strength at 6 months(Baseline, 3 months,6 months)
- Change in Short Physical Performance Battery (SPPB) score at 6 months(Baseline,3 months, 6 months)
- Change in skeletal muscle mass index (SMI) at 6 months(Baseline,3 months, 6 months)
- Change in bone mineral density (BMD) at 6 months(Baseline,6 months)
- Change in quality of life at 6 months(Baseline,3 months, 6 months)
- Incidence of falls within 6 months(6 months)
研究者
Jiawei Jiang
Attending Physician
Affiliated 2 Hospital of Nantong University
研究点 (2)
标识符
- NCT 编号
- NCT07845656
- 其他研究编号
- 2025LY056
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (3个月后)
- 研究完成日期
- (9个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否