Coronary Artery DiseaseNCT07762898
Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty
A study testing ITHBC-Based Sedentary Behavior Intervention in people with Coronary Artery Disease and Sedentary Behavior, run by Gansu University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Coronary Artery Disease, Sedentary Behavior, Prefrailty
- What is being tested?
- ITHBC-Based Sedentary Behavior Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hospital of Gansu University of Chinese Medicine
Lanzhou, Gansu, 730000
yajie xie, +8616620323694, 16620323694@163.com
16620323694@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Sedentary Behavior, Prefrailty
- Being tested
- ITHBC-Based Sedentary Behavior Intervention
- Keywords
- Integrated Theory of Health Behavior Change, Older Adults, Behavior Change, Sedentary Time, Physical Activity
- Medical subject headings
- Coronary Artery Disease, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITHBC-Based Sedentary Behavior InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 8, Month 1, and Month 3
Secondary outcomes (5)
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.
Measured: Baseline, Day 8, Month 1, and Month 3
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.
Measured: Baseline, Day 8, Month 1, and Month 3
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.
Measured: Baseline, Day 8, Month 1, and Month 3
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.
Measured: Baseline, Month 1，Month 3
Change From Baseline in Health-Related Quality of Life Assessed by the SF-36
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.
Measured: Baseline, Month 1 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gansu University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Yajie, Gansu University of Chinese Medicine
- Investigators
- Yajie Xie, Principal investigator, Gansu University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762898
- Sponsor's protocol ID
- ITHBC-SB-2026-061
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07762898
- Acronym / sponsor ID
- ITHBC-SB-2026-061
- Conditions
- Coronary Artery Disease, Sedentary Behavior, Prefrailty
- Keywords
- Integrated Theory of Health Behavior Change, Older Adults, Behavior Change, Sedentary Time, Physical Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Gansu University of Chinese MedicineUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ITHBC-Based Sedentary Behavior Intervention | Experimental | Behavioral: ITHBC-Based Sedentary Behavior InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITHBC-Based Sedentary Behavior InterventionThe 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. | Behavioural | ITHBC-Based Sedentary Behavior Intervention |
Primary outcome
Change in Average Daily Sedentary Time
Time frame: 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.
5 secondary outcomes
Change From Baseline in Longest Continuous Sedentary Bout Duration
Time frame: Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Frequency of Sedentary Bouts Lasting 30 Minutes or Longer
Time frame: Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Self-Efficacy to Reduce Sedentary Behavior
Time frame: Baseline, Day 8, Month 1, and Month 3
Change From Baseline in Fried Frailty Phenotype Score
Time frame: Baseline, Month 1，Month 3
Change From Baseline in Health-Related Quality of Life Assessed by the SF-36
Time frame: Baseline, Month 1 and Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yajie Xie principal investigator
Gansu University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITHBC-Based Sedentary Behavior Intervention in people with Coronary Artery Disease and Sedentary Behavior, run by Gansu University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yajie Xie (+8616620323694, 16620323694@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Daily Sedentary Time (time frame: Baseline, Day 8, Month 1, and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.