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

NCT07762898 | Not Yet Recruiting

• 1 other identifier: ITHBC-SB-2026-061
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Sedentary Behavior; Prefrailty

Keywords

Integrated Theory of Health Behavior Change; Older Adults; Behavior Change; Sedentary Time; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Change in Average Daily Sedentary Time

  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

Secondary Outcomes (5)

• Change From Baseline in Longest Continuous Sedentary Bout Duration

  Baseline, Day 8, Month 1, and Month 3

• Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer

  Baseline, Day 8, Month 1, and Month 3

• Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior

  Baseline, Day 8, Month 1, and Month 3

• Change From Baseline in Fried Frailty Phenotype Score

  Baseline, Month 1，Month 3

• Change From Baseline in Health-Related Quality of Life Assessed by the SF-36

  Baseline, Month 1 and Month 3

Study Arms (2)

ITHBC-Based Sedentary Behavior Intervention

EXPERIMENTAL

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.

Behavioral: ITHBC-Based Sedentary Behavior Intervention

Usual Care

NO INTERVENTION

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.

Interventions

ITHBC-Based Sedentary Behavior Intervention BEHAVIORAL

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.

ITHBC-Based Sedentary Behavior Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gansu University of Chinese Medicine: lead

Study Sites (1)

Affiliated Hospital of Gansu University of Chinese Medicine

Lanzhou, Gansu, 730000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Officials

• Yajie Xie

  Gansu University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yajie Xie

CONTACT

+8616620323694; 16620323694@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will be blinded to group allocation. Participants, investigators, and intervention providers will not be blinded because of the nature of the behavioral intervention. Outcome assessors will not participate in participant recruitment, randomization, or intervention delivery. Participants will be instructed not to disclose their group allocation to the outcome assessors during assessments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student in Nursing

Model Details: This is a single-center, prospective, two-arm, parallel-group randomized controlled trial with a 1:1 allocation ratio. Participants will be stratified according to the Fried frailty phenotype into a pre-frail stratum (score 1-2) and a frail stratum (score 3-5). Within each stratum, participants will be randomized using variable block sizes of 4 and 6.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)