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

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

Registry ID
NCT07762898
Source registry
NCT
Status
NOT_YET_RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
Gansu University of Chinese Medicine
Enrollment
64
Start date
2026-09-01
Completion date
2027-01-01
Last update
2026-08-13

Conditions

Summary

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.

Detailed description

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.

Interventions

Inclusion criteria

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

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.

Primary outcomes

[{"measure":"Change in Average Daily Sedentary Time","timeFrame":"Baseline, Day 8, Month 1, and Month 3"}]

Locations

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