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A Home-based Multicomponent Exercise Intervention Program Based on the Fogg Behavior Model (FBM) for Older Adults With Osteosarcopenia and Frailty

2026年9月23日 更新者:Jiawei Jiang

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)

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.

研究概览

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Jiangsu
      • Nantong、Jiangsu、中国、226000
        • 招聘中
        • Nantong First People's Hospital
        • 接触:
      • Nantong、Jiangsu、中国、226001
        • 招聘中
        • Nantong First People's Hospital
        • 接触:
        • 副研究员:
          • Yan Hai Gu, Bachelor
        • 副研究员:
          • Qian Zhi Gong, Master
        • 副研究员:
          • Hua Guan Xu, Doctor
        • 首席研究员:
          • Yu Yu Sun, Doctor
        • 副研究员:
          • Qin Xuan, Bachelor
        • 副研究员:
          • Yan Dong Zhu, Master

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. The disease is in stable condition.
  2. Aged 60-85 years or older.
  3. Meet the diagnostic criteria in the 2022 Expert Consensus on Sarcopenia-Osteoporosis.
  4. The score of frailty scale is ≥1, indicating patients are in pre-frailty or frailty status.
  5. Clear consciousness, normal communication, capable of cooperating with exercise intervention; not living alone and will not leave the residence within half a year.
  6. Own a smartphone and voluntarily participate in this study.

Exclusion Criteria:

  1. Severe cardiopulmonary, hepatic or renal dysfunction.
  2. Uncontrolled severe neurological or psychiatric diseases.
  3. Recent fracture or unable to perform exercise training.
  4. Malignant tumor, severe infectious disease.
  5. Participate in other exercise intervention studies simultaneously.
  6. Cognitive impairment and cannot cooperate with follow-up.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

Participants receive a 6-month multi-component home-based exercise intervention based on the Fogg Behavior Model, divided into 3 stages. Stage 1 (Weeks 1-2): motivation cultivation, health assessment, risk screening and health education. Stage 2 (Weeks 3-12): personalized exercise prescription including warm-up, aerobic, resistance, balance and flexibility training, with progressive intensity and regular follow-up. Stage 3 (Months 4-6): habit formation, self-management reinforcement and incentive strategies. The intervention aims to improve muscle mass, physical function and frailty status in older adults with sarcopenia-osteoporosis.

有源比较器:Control group

Routine health education about osteoporosis and sarcopenia. No systematic supervised exercise intervention.

Participants receive routine osteoporosis health education and standard nursing care. General advice on diet, fall prevention and daily activity is provided, without the multi-component staged exercise intervention based on the Fogg Behavior Model. Regular outpatient follow-up is arranged.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in frailty phenotype score at 6 months
大体时间: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.

Baseline, 3 months, 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in handgrip strength at 6 months
大体时间:Baseline, 3 months,6 months

The change of handgrip strength (kg) from baseline to 6-month follow-up

Baseline, 3 months,6 months
Change in Short Physical Performance Battery (SPPB) score at 6 months
大体时间:Baseline,3 months, 6 months

The change of SPPB score from baseline to 6-month follow-up. SPPB ranges from 0 to 12, higher score indicates better physical performance.

Baseline,3 months, 6 months
Change in skeletal muscle mass index (SMI) at 6 months
大体时间:Baseline,3 months, 6 months

The change of skeletal muscle mass index (kg/m²) from baseline to 6-month follow-up, assessed by bioelectrical impedance analysis.

Baseline,3 months, 6 months
Change in bone mineral density (BMD) at 6 months
大体时间:Baseline,6 months

The change of lumbar spine bone mineral density (g/cm²) from baseline to 6-month follow-up, measured by dual-energy X-ray absorptiometry (DXA).

Baseline,6 months
Change in quality of life at 6 months
大体时间:Baseline,3 months, 6 months

The change of quality of life measured by the 12-item Short Form Health Survey (SF-12) from baseline to 6-month follow-up.

Baseline,3 months, 6 months
Incidence of falls within 6 months
大体时间:6 months

The number of participants who experienced fall events during the 6-month intervention period.

6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年9月23日

首先提交符合 QC 标准的

2026年9月23日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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