Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorGansu University of Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ITHBC-Based Sedentary Behavior Intervention
BehavioralThe 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: ITHBC-Based Sedentary Behavior InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline, Day 8, Month 1, and Month 3Secondary outcomes
1
Change From Baseline in Longest Continuous Sedentary Bout Duration
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.
Time frame
Baseline, Day 8, Month 1, and Month 32
Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer
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.
Time frame
Baseline, Day 8, Month 1, and Month 33
Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior
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.
Time frame
Baseline, Day 8, Month 1, and Month 34
Change From Baseline in Fried Frailty Phenotype Score
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.
Time frame
Baseline, Month 1，Month 3Sponsors and contacts
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Source ClinicalTrials.gov
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