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Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty

2026年8月12日 更新者：Xie Yajie、Gansu University of Chinese Medicine

Development and Application of a Sedentary Behavior Intervention Program Based on the Integrated Theory of Health Behavior Change for Older Adults With Coronary Heart Disease and Frailty

This study aims to evaluate the feasibility and effectiveness of a sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC) in older adults with coronary heart disease and frailty. Participants will be randomly assigned to an intervention group or a control group. The intervention is designed around the three core components of ITHBC-knowledge and beliefs, self-regulation skills and abilities, and social facilitation-to help participants reduce sedentary behavior, improve physical activity, and enhance their ability to manage health-related behaviors. The study will include a 1-month intervention period followed by a 2-month follow-up period, with a total study duration of 3 months for each participant. Changes in sedentary behavior and other health-related outcomes will be assessed throughout the study period.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study is designed to develop and evaluate a sedentary behavior intervention for older adults with coronary heart disease and frailty based on the Integrated Theory of Health Behavior Change (ITHBC). The intervention framework incorporates the three major components of ITHBC: knowledge and beliefs, self-regulation skills and abilities, and social facilitation.

The intervention is intended to improve participants' knowledge and beliefs regarding sedentary behavior and its health consequences, strengthen their motivation and confidence for behavior change, enhance self-regulation skills such as goal setting, self-monitoring, action planning, feedback, and behavioral adjustment, and provide appropriate professional, family, and social support. These strategies are integrated to facilitate the initiation and maintenance of sedentary behavior change.

The study consists of a 1-month structured intervention period followed by a 2-month follow-up period, resulting in a total study duration of 3 months for each participant. Participants in the intervention group will receive the ITHBC-based sedentary behavior intervention according to the study protocol, while participants in the control group will receive the comparator specified in the protocol. The effectiveness of the intervention will be evaluated by comparing changes in sedentary behavior and other prespecified health-related outcomes between the groups during the intervention and follow-up periods.

研究类型

介入性

注册 (估计的)

64

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

  • 中国
    • Gansu
      • Lanzhou、Gansu、中国、730000
        • Affiliated Hospital of Gansu University of Chinese Medicine
        • 接触：
        • 接触：
        • 首席研究员：
          • Yajie Xie

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 60 years or older.
  • Diagnosis of stable coronary artery disease according to the Chinese Primary -Care Guideline for Stable Coronary Artery Disease (2020).
  • Canadian Cardiovascular Society (CCS) angina class I or II.
  • Fried Frailty Phenotype score of 1 or higher, including participants with pre-frailty (score 1-2) or frailty (score 3-5).
  • Total sedentary time of 6 hours or more per day.
  • The participant or the participant's primary caregiver is able to use the WeChat application.
  • Able and willing to provide informed consent and voluntarily participate in the study.

Exclusion Criteria:

  • Currently participating in another research study.
  • Presence of a malignant tumor.
  • Presence of a severe infectious disease.
  • Presence of a physical impairment that substantially limits limb mobility.
  • Presence of a language impairment that prevents effective communication or -completion of study assessments.
  • Presence of cognitive impairment that prevents understanding of study procedures or completion of study assessments.

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：支持治疗
  • 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：ITHBC-Based Sedentary Behavior Intervention
Participants in this arm will receive a 1-month sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC), in addition to usual care. The intervention incorporates strategies targeting knowledge and beliefs, self-regulation skills and abilities, and social facilitation. Participants will subsequently be followed for 2 months, resulting in a total study duration of 3 months.
行为的：ITHBC-Based Sedentary Behavior Intervention
The intervention is a 1-month nurse-delivered sedentary behavior intervention based on the Integrated Theory of Health Behavior Change (ITHBC). It addresses three core components of ITHBC: knowledge and beliefs, self-regulation skills and abilities, and social facilitation. Intervention strategies include health education related to sedentary behavior and coronary heart disease, individualized goal setting, self-monitoring, action planning, feedback, and professional and family/social support to facilitate reduction of sedentary behavior and promote physical activity. After the 1-month intervention period, participants will receive a 2-month follow-up to support maintenance of behavior change.
无干预：Usual Care
Participants in this arm will receive usual care provided by the clinical team and will not receive the ITHBC-based sedentary behavior intervention. Participants will be followed for the same 3-month study period as the intervention group.

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 Average Daily Sedentary Time
大体时间：Baseline, Day 8, Month 1, and Month 3
Average daily sedentary time will be assessed using the Older Adults Sedentary Behavior Questionnaire. The questionnaire assesses sedentary behavior during the previous 7 days across seven common sedentary domains, including watching television or videos, using a mobile phone or listening to music or radio, reading, socializing with family or friends, engaging in sedentary hobbies, resting or napping, and other sedentary activities. Time spent in each domain is reported in 15-minute increments from 0 minutes to 6 hours. Daily total sedentary time will be derived from the reported sedentary time across the seven domains and expressed as time spent sedentary per day. Lower values indicate less sedentary time.
Baseline, Day 8, Month 1, and Month 3

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Longest Continuous Sedentary Bout Duration
大体时间：Baseline, Day 8, Month 1, and Month 3
The longest continuous sedentary bout duration will be assessed using the Older Adults Sedentary Behavior Questionnaire. Participants will report the longest uninterrupted period of sitting, reclining, or lying during the day. Responses range from 0 minutes to 6 hours in 15-minute increments. A shorter duration indicates less prolonged sedentary behavior.
Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer
大体时间：Baseline, Day 8, Month 1, and Month 3
The frequency of prolonged sedentary bouts will be assessed using the Older Adults Sedentary Behavior Questionnaire. Participants will report the number of times per day that they remain sitting, reclining, or lying continuously for 30 minutes or longer. Response options range from 0 times to 10 or more times per day. A lower frequency indicates fewer prolonged sedentary bouts.
Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior
大体时间：Baseline, Day 8, Month 1, and Month 3
Self-efficacy for reducing sedentary behavior will be assessed using the Chinese version of the Self-Efficacy to Reduce Sedentary Behavior (SRSB) Scale. The scale contains 9 items, each rated on a 5-point scale from 1 ("not at all confident") to 5 ("very confident"). The total score ranges from 9 to 45, with higher scores indicating greater confidence in reducing sedentary behavior.
Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Fried Frailty Phenotype Score
大体时间：Baseline, Month 1，Month 3
Frailty will be assessed using the Fried Frailty Phenotype, which includes five criteria: unintentional weight loss, reduced grip strength, exhaustion, slow walking speed, and low physical activity. Each criterion contributes 1 point, resulting in a total score ranging from 0 to 5. A score of 0 indicates robust status, 1-2 indicates pre-frailty, and 3-5 indicates frailty. Higher scores indicate greater frailty.
Baseline, Month 1，Month 3
Change From Baseline in Health-Related Quality of Life Assessed by the SF-36
大体时间：Baseline, Month 1 and Month 3
Health-related quality of life will be assessed using the Chinese version of the 36-Item Short Form Health Survey (SF-36). The instrument contains 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Higher scores indicate better health-related quality of life.
Baseline, Month 1 and Month 3

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

Gansu University of Chinese Medicine

调查人员

  • 首席研究员：Yajie Xie、Gansu University of Chinese Medicine

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 (估计的)

2026年9月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年8月10日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月13日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ITHBC-SB-2026-061

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made publicly available because no formal data-sharing plan has been established for this study. Study data will be managed and stored in accordance with the approved study protocol and institutional requirements for participant confidentiality and data protection.

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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