Coronary Artery DiseaseNCT07243444
Home-Based Versus Center-Based Cardiac Rehabilitation After CABG Surgery
A study testing Structured Exercise Program and Standard Health Education in people with Coronary Artery Disease, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This randomized controlled trial was designed to compare the efficacy of a 12-week home-based telerehabilitation (HBTCR) program against traditional center-based cardiac rehabilitation (CBCR) and usual care in patients who have undergone coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Structured Exercise Program and Standard Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 30 to 75 years.
- Had undergone Coronary Artery Bypass Grafting (CABG) 4 to 8 weeks prior.
- In a stable clinical condition.
- Able to provide written informed consent.
- No cognitive impairments.
Who cannot join
- Acute decompensated heart failure.
- Severe physical comorbidities (e.g., fractures, severe hearing impairment) that would preclude participation in an exercise program.
- Recent stroke or pulmonary embolism.
- Significant hepatic or renal dysfunction.
- Unstable angina.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Efficacy of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Cardiopulmonary Function and Exercise Capacity in Patients After Coronary Artery Bypass Grafting: A Randomized Controlled Trial
This randomized controlled trial was designed to compare the efficacy of a 12-week home-based telerehabilitation (HBTCR) program against traditional center-based cardiac rehabilitation (CBCR) and usual care in patients who have undergone coronary artery bypass grafting (CABG). The primary goal was to assess changes in cardiopulmonary function, measured by peak oxygen consumption (VO₂ peak), and exercise capacity, measured by the 6-minute walk test (6MWT), to determine if HBTCR is a viable alternative to CBCR.
Read the detailed description
While cardiac rehabilitation (CR) is a Class IA recommendation for patients after coronary artery bypass grafting (CABG) to improve long-term outcomes, participation in traditional center-based programs (CBCR) is low due to barriers like travel, cost, and scheduling. Home-based telerehabilitation (HBTCR) emerges as a potential solution. This study was a three-arm, prospective, single-center randomized controlled trial to rigorously evaluate if a structured HBTCR program is as effective as CBCR. A total of 110 patients, 4-8 weeks post-CABG, were randomized into three groups: HBTCR, CBCR, or a control group receiving usual care with educational pamphlets. The HBTCR group performed prescribed exercises at home, using wearable monitors and a mobile app, with weekly remote monitoring by a rehabilitation team. The CBCR group attended supervised sessions at the hospital three times a week. The control group received standard follow-up and educational materials. The interventions lasted 12 weeks, with assessments of cardiopulmonary function, exercise capacity, cardiac function, psychological status, and quality of life conducted at baseline and at 12 weeks. The study aimed to provide robust evidence for HBTCR as an effective alternative model of care for post-CABG rehabilitation.
- Conditions
- Coronary Artery Disease
- Being tested
- Structured Exercise Program, Standard Health Education
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise ProgramBehavioural
A 12-week comprehensive cardiac rehabilitation program. The exercise prescription (frequency, intensity, duration, type) was based on a baseline cardiopulmonary exercise test, typically starting at 40-60% of heart rate reserve and increasing progressively. The program included aerobic and resistance training components. This intervention was delivered either remotely (HBTCR group) or in-person (CBCR group), three times per week.
Standard Health EducationBehavioural
Participants received routine follow-up and standard health education pamphlets covering topics such as medication adherence, diet, and general advice on physical activity, without a structured or monitored exercise plan.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Telerehabilitation (HBTCR) Group | Experimental | Participants received a personalized 12-week cardiac rehabilitation program to perform at home. They were provided with a wearable heart rate monitor and used a mobile application to log their exercise sessions and vital signs. A rehabilitation team remotely monitored their progress and communicated weekly via phone or video call. Receives: Behavioral: Structured Exercise Program |
| Center-Based Cardiac Rehabilitation (CBCR) Group | Active comparator | Participants attended supervised cardiac rehabilitation sessions at the hospital's rehabilitation center three times per week for 12 weeks. Each session included warm-up, aerobic exercise, resistance training, and cool-down under the direct supervision of a healthcare team. Receives: Behavioral: Structured Exercise Program |
| Control Group | Sham comparator | Participants received usual care, which included routine follow-up appointments and standard health education delivered through verbal instructions and printed pamphlets. They did not participate in a structured or monitored exercise program. Receives: Behavioral: Standard Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Consumption (VO₂ peak)
Measured in mL/kg/min by cardiopulmonary exercise testing (CPET) on a treadmill using a symptom-limited protocol. The change from baseline to 12 weeks was assessed.
Measured: Baseline, 12 weeks
Change in 6-Minute Walk Distance (6MWD)
Measured in meters, assessing the maximum distance a patient can walk in 6 minutes on a flat, hard surface. The change from baseline to 12 weeks was assessed.
Measured: Baseline, 12 weeks
Secondary outcomes (10)
Change in Left Ventricular Ejection Fraction (LVEF)
Assessed as a percentage (%) by transthoracic echocardiography.
Measured: Baseline, 12 weeks
Change in Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio (FEV1/FVC)
Measured by spirometry to assess pulmonary function.
Measured: Baseline, 12 weeks
Change in Psychological Status (Anxiety)
Assessed using the Hamilton Anxiety Scale (HAMA). A lower score indicates less anxiety.
Measured: Baseline, 12 weeks
Change in Psychological Status (Depression)
Assessed using the Hamilton Depression Scale (HAMD). A lower score indicates less depression.
Measured: Baseline, 12 weeks
Change in Quality of Life
Measured using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), which assesses eight domains of health.
Measured: Baseline, 12 weeks
Change in Cardiac Index (CI)
Assessed non-invasively to measure cardiac output relative to body surface area.
Measured: Baseline, 12 weeks
Adherence to Rehabilitation Program
Calculated as the percentage of completed sessions out of the 36 total prescribed sessions for the HBTCR and CBCR groups.
Measured: Up to 12 weeks
Incidence of Major Adverse Events
Number of participants experiencing major adverse cardiovascular events (e.g., death, myocardial infarction, urgent revascularization).
Measured: Up to 12 weeks
Change in Stroke Volume Index (SVI)
Assessed non-invasively to measure the volume of blood pumped from the ventricle per beat relative to body surface area.
Measured: Baseline, 12 weeks
Change in Systemic Vascular Resistance Index (SVRI)
Assessed non-invasively to measure the resistance to blood flow offered by all systemic vasculature, indexed to body surface area.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Liu, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243444
- Sponsor's protocol ID
- S00775-1
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Cardiopulmonary Function and Exercise Capacity in Patients After Coronary Artery Bypass Grafting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07243444
- Acronym / sponsor ID
- S00775-1
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 21 Nov 2025 (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 randomized controlled trial was designed to compare the efficacy of a 12-week home-based telerehabilitation (HBTCR) program against traditional center-based cardiac rehabilitation (CBCR) and usual care in patients who have undergone coronary artery bypass grafting (CABG). The primary goal was to assess changes in cardiopulmonary function, measured by peak oxygen consumption (VO₂ peak), and exercise capacity, measured by the 6-minute walk test (6MWT), to determine if HBTCR is a viable alternative to CBCR.
Detailed description
While cardiac rehabilitation (CR) is a Class IA recommendation for patients after coronary artery bypass grafting (CABG) to improve long-term outcomes, participation in traditional center-based programs (CBCR) is low due to barriers like travel, cost, and scheduling. Home-based telerehabilitation (HBTCR) emerges as a potential solution. This study was a three-arm, prospective, single-center randomized controlled trial to rigorously evaluate if a structured HBTCR program is as effective as CBCR. A total of 110 patients, 4-8 weeks post-CABG, were randomized into three groups: HBTCR, CBCR, or a control group receiving usual care with educational pamphlets. The HBTCR group performed prescribed exercises at home, using wearable monitors and a mobile app, with weekly remote monitoring by a rehabilitation team. The CBCR group attended supervised sessions at the hospital three times a week. The control group received standard follow-up and educational materials. The interventions lasted 12 weeks, with assessments of cardiopulmonary function, exercise capacity, cardiac function, psychological status, and quality of life conducted at baseline and at 12 weeks. The study aimed to provide robust evidence for HBTCR as an effective alternative model of care for post-CABG rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-Based Telerehabilitation (HBTCR) Group | Experimental | Behavioral: Structured Exercise ProgramParticipants received a personalized 12-week cardiac rehabilitation program to perform at home. They were provided with a wearable heart rate monitor and used a mobile application to log their exercise sessions and vital signs. A rehabilitation team remotely monitored their progress and communicated weekly via phone or video call. |
| Center-Based Cardiac Rehabilitation (CBCR) Group | Active comparator | Behavioral: Structured Exercise ProgramParticipants attended supervised cardiac rehabilitation sessions at the hospital's rehabilitation center three times per week for 12 weeks. Each session included warm-up, aerobic exercise, resistance training, and cool-down under the direct supervision of a healthcare team. |
| Control Group | Sham comparator | Behavioral: Standard Health EducationParticipants received usual care, which included routine follow-up appointments and standard health education delivered through verbal instructions and printed pamphlets. They did not participate in a structured or monitored exercise program. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 30 to 75 years.
- Had undergone Coronary Artery Bypass Grafting (CABG) 4 to 8 weeks prior.
- In a stable clinical condition.
- Able to provide written informed consent.
- No cognitive impairments.
Key exclusion criteria (5 listed)
- Acute decompensated heart failure.
- Severe physical comorbidities (e.g., fractures, severe hearing impairment) that would preclude participation in an exercise program.
- Recent stroke or pulmonary embolism.
- Significant hepatic or renal dysfunction.
- Unstable angina.
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 |
|---|---|---|
| Structured Exercise ProgramA 12-week comprehensive cardiac rehabilitation program. The exercise prescription (frequency, intensity, duration, type) was based on a baseline cardiopulmonary exercise test, typically starting at 40-60% of heart rate reserve and increasing progressively. The program included aerobic and resistance training components. This intervention was delivered either remotely (HBTCR group) or in-person (CBCR group), three times per week. | Behavioural | Center-Based Cardiac Rehabilitation (CBCR) Group, Home-Based Telerehabilitation (HBTCR) Group |
| Standard Health EducationParticipants received routine follow-up and standard health education pamphlets covering topics such as medication adherence, diet, and general advice on physical activity, without a structured or monitored exercise plan. | Behavioural | Control Group |
Primary outcome
Change in Peak Oxygen Consumption (VO₂ peak)
Time frame: Baseline, 12 weeks
Measured in mL/kg/min by cardiopulmonary exercise testing (CPET) on a treadmill using a symptom-limited protocol. The change from baseline to 12 weeks was assessed.
Change in 6-Minute Walk Distance (6MWD)
Time frame: Baseline, 12 weeks
Measured in meters, assessing the maximum distance a patient can walk in 6 minutes on a flat, hard surface. The change from baseline to 12 weeks was assessed.
10 secondary outcomes
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline, 12 weeks
Change in Forced Expiratory Volume in 1 second to Forced Vital Capacity Ratio (FEV1/FVC)
Time frame: Baseline, 12 weeks
Change in Psychological Status (Anxiety)
Time frame: Baseline, 12 weeks
Change in Psychological Status (Depression)
Time frame: Baseline, 12 weeks
Change in Quality of Life
Time frame: Baseline, 12 weeks
Change in Cardiac Index (CI)
Time frame: Baseline, 12 weeks
Adherence to Rehabilitation Program
Time frame: Up to 12 weeks
Incidence of Major Adverse Events
Time frame: Up to 12 weeks
Change in Stroke Volume Index (SVI)
Time frame: Baseline, 12 weeks
Change in Systemic Vascular Resistance Index (SVRI)
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise Program and Standard Health Education in people with Coronary Artery Disease, run by The First Hospital of Hebei Medical University 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Nov 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Oxygen Consumption (VO₂ peak) (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. 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 21 Nov 2025.