Psychological Distress After Coronary Artery Bypass Grafting (CABG)NCT07232693
Telerehabilitation vs. Center-Based Rehab for Psychological Well-being After CABG
A study testing Home-Based Telerehabilitation Cardiac Rehabilitation in people with Psychological Distress After Coronary Artery Bypass Grafting (CABG), run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This randomized controlled trial aims to determine if a 12-week home-based telerehabilitation (HBTCR) program is as effective as traditional center-based cardiac rehabilitation (CBCR) in improving psychological well-being (anxiety and depression) and quality of life in patients who have undergone coronary artery… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Psychological Distress After Coronary Artery Bypass Grafting (CABG)
- What is being tested?
- Home-Based Telerehabilitation Cardiac Rehabilitation
- 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 Jun 2024to 1 Aug 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
- Aged 30-75 years.
- 4-8 weeks post-Coronary Artery Bypass Grafting (CABG).
- In clinically stable condition.
- Had access to a smartphone and were willing to use it for the program.
- Willing to participate in a 12-week rehabilitation program.
- Provided written informed consent.
Who cannot join
- Presence of severe and unstable comorbidities (e.g., uncontrolled heart failure, recent stroke).
- Severe orthopedic limitations that would prevent participation in exercise.
- Significant cognitive impairment or psychiatric disorders that would interfere with participation.
- Inability to provide informed consent.
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: The Impact of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Anxiety, Depression, and Quality of Life After Coronary Artery Bypass Grafting: A Randomized Controlled Trial
This randomized controlled trial aims to determine if a 12-week home-based telerehabilitation (HBTCR) program is as effective as traditional center-based cardiac rehabilitation (CBCR) in improving psychological well-being (anxiety and depression) and quality of life in patients who have undergone coronary artery bypass grafting (CABG). A third group receiving usual care served as a control.
Read the detailed description
Psychological distress, such as anxiety and depression, is common after coronary artery bypass grafting (CABG) and negatively affects recovery and quality of life. While center-based cardiac rehabilitation (CBCR) effectively addresses these issues, participation is often limited by barriers like travel, cost, and scheduling. Home-based telerehabilitation (HBTCR) offers a potential solution. This single-center, prospective, three-arm randomized controlled trial was designed to compare the effectiveness of HBTCR versus CBCR and usual care. A total of 110 clinically stable patients, 4-8 weeks post-CABG, were randomly assigned in a 1:1:1 ratio to an HBTCR group, a CBCR group, or a control group. The intervention period was 12 weeks. The study hypothesized that the HBTCR program, which includes a personalized exercise plan, remote monitoring via a wearable device and mobile app, and weekly psychosocial support from a nurse, would be as effective as the traditional supervised in-person CBCR program in reducing symptoms of anxiety and depression and improving health-related quality of life.
- Being tested
- Home-Based Telerehabilitation Cardiac Rehabilitation, Usual Care
- Keywords
- Coronary Artery Bypass Grafting, Telerehabilitation, Anxiety, Depression, Quality of Life, Cardiac Rehabilitation
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Telerehabilitation Cardiac RehabilitationBehavioural
A 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse.
Home-Based Telerehabilitation Cardiac RehabilitationBehavioural
A 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse.
Usual CareBehavioural
Standard postoperative care including prescribed medications and routine follow-up, supplemented with health education pamphlets on lifestyle modification. No structured or supervised rehabilitation was provided.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Telerehabilitation (HBTCR) Group | Experimental | Participants received a personalized 12-week exercise program to perform at home. They were provided with a wearable heart rate monitor and a mobile application to log their activities. A dedicated cardiac rehabilitation nurse contacted each patient weekly via phone or video call to review progress, adjust the exercise plan, and provide structured psychosocial support and counseling. Receives: Behavioral: Home-Based Telerehabilitation Cardiac Rehabilitation |
| Center-Based Cardiac Rehabilitation (CBCR) Group | Active comparator | Participants attended 36 supervised sessions at the hospital's cardiac rehabilitation center over 12 weeks (3 sessions/week). Each session included aerobic and resistance exercises. In addition, patients attended weekly group sessions for health education and psychosocial support, covering topics like stress management and coping strategies. Receives: Behavioral: Home-Based Telerehabilitation Cardiac Rehabilitation |
| Control Group | Sham comparator | Participants received usual care, which included standard postoperative medical advice and health education pamphlets detailing general recommendations for diet, medication, and physical activity. They did not receive any structured exercise prescription or formal psychological support from the study team. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Symptoms
The change from baseline in the Hamilton Anxiety Scale (HAMA) score. The HAMA scale is a clinician-rated scale where higher scores indicate greater symptom severity.
Measured: Baseline, 12 Weeks
Change in Depression Symptoms
The change from baseline in the 17-item Hamilton Depression Scale (HAMD) score. The HAMD is a clinician-rated scale where higher scores indicate greater symptom severity.
Measured: Baseline, 12 Weeks
Secondary outcomes (1)
Change in Health-Related Quality of Life
The change from baseline in scores on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The SF-36 assesses eight domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Scores for each domain range from 0 to 100, with higher scores indicating better quality of life.
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 posted18 Nov 2025
- Study start1 Jun 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological Distress After Coronary Artery Bypass Grafting (CABG)Studies 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
- NCT07232693
- Sponsor's protocol ID
- S00775-2
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Wang X, Li H, Wang C, Kong M, Zhang M, Ma J, Liu H. The impact of home-based telerehabilitation versus center-based cardiac rehabilitation on anxiety, depression, and quality of life after coronary artery bypass grafting: a randomized controlled trial. BMC Cardiovasc Disord. 2026 Apr 25;26(1):499. doi: 10.1186/s12872-026-05703-1.
PubMed 42035003
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Anxiety, Depression, and Quality of Life After Coronary Artery Bypass Grafting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07232693
- Acronym / sponsor ID
- S00775-2
- Keywords
- Coronary Artery Bypass Grafting, Telerehabilitation, Anxiety, Depression, Quality of Life, Cardiac Rehabilitation
- 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 Jun 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 18 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 aims to determine if a 12-week home-based telerehabilitation (HBTCR) program is as effective as traditional center-based cardiac rehabilitation (CBCR) in improving psychological well-being (anxiety and depression) and quality of life in patients who have undergone coronary artery bypass grafting (CABG). A third group receiving usual care served as a control.
Detailed description
Psychological distress, such as anxiety and depression, is common after coronary artery bypass grafting (CABG) and negatively affects recovery and quality of life. While center-based cardiac rehabilitation (CBCR) effectively addresses these issues, participation is often limited by barriers like travel, cost, and scheduling. Home-based telerehabilitation (HBTCR) offers a potential solution. This single-center, prospective, three-arm randomized controlled trial was designed to compare the effectiveness of HBTCR versus CBCR and usual care. A total of 110 clinically stable patients, 4-8 weeks post-CABG, were randomly assigned in a 1:1:1 ratio to an HBTCR group, a CBCR group, or a control group. The intervention period was 12 weeks. The study hypothesized that the HBTCR program, which includes a personalized exercise plan, remote monitoring via a wearable device and mobile app, and weekly psychosocial support from a nurse, would be as effective as the traditional supervised in-person CBCR program in reducing symptoms of anxiety and depression and improving health-related quality of life.
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: Home-Based Telerehabilitation Cardiac RehabilitationParticipants received a personalized 12-week exercise program to perform at home. They were provided with a wearable heart rate monitor and a mobile application to log their activities. A dedicated cardiac rehabilitation nurse contacted each patient weekly via phone or video call to review progress, adjust the exercise plan, and provide structured psychosocial support and counseling. |
| Center-Based Cardiac Rehabilitation (CBCR) Group | Active comparator | Behavioral: Home-Based Telerehabilitation Cardiac RehabilitationParticipants attended 36 supervised sessions at the hospital's cardiac rehabilitation center over 12 weeks (3 sessions/week). Each session included aerobic and resistance exercises. In addition, patients attended weekly group sessions for health education and psychosocial support, covering topics like stress management and coping strategies. |
| Control Group | Sham comparator | Behavioral: Usual CareParticipants received usual care, which included standard postoperative medical advice and health education pamphlets detailing general recommendations for diet, medication, and physical activity. They did not receive any structured exercise prescription or formal psychological support from the study team. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 30-75 years.
- 4-8 weeks post-Coronary Artery Bypass Grafting (CABG).
- In clinically stable condition.
- Had access to a smartphone and were willing to use it for the program.
- Willing to participate in a 12-week rehabilitation program.
Key exclusion criteria (4 listed)
- Presence of severe and unstable comorbidities (e.g., uncontrolled heart failure, recent stroke).
- Severe orthopedic limitations that would prevent participation in exercise.
- Significant cognitive impairment or psychiatric disorders that would interfere with participation.
- Inability to provide informed consent.
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 |
|---|---|---|
| Home-Based Telerehabilitation Cardiac RehabilitationA 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse. | Behavioural | Home-Based Telerehabilitation (HBTCR) Group |
| Home-Based Telerehabilitation Cardiac RehabilitationA 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse. | Behavioural | Center-Based Cardiac Rehabilitation (CBCR) Group |
| Usual CareStandard postoperative care including prescribed medications and routine follow-up, supplemented with health education pamphlets on lifestyle modification. No structured or supervised rehabilitation was provided. | Behavioural | Control Group |
Primary outcome
Change in Anxiety Symptoms
Time frame: Baseline, 12 Weeks
The change from baseline in the Hamilton Anxiety Scale (HAMA) score. The HAMA scale is a clinician-rated scale where higher scores indicate greater symptom severity.
Change in Depression Symptoms
Time frame: Baseline, 12 Weeks
The change from baseline in the 17-item Hamilton Depression Scale (HAMD) score. The HAMD is a clinician-rated scale where higher scores indicate greater symptom severity.
1 secondary outcome
Change in Health-Related Quality of Life
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 18 Nov 2025.
- Derived from this study: PubMed 42035003Liu Y, Wang X, Li H, Wang C, Kong M, Zhang M, Ma J, Liu H. The impact of home-based telerehabilitation versus center-based cardiac rehabilitation on anxiety, depression, and quality of life after coronary artery bypass grafting: a randomized controlled trial. BMC Cardiovasc Disord. 2026 Apr 25;26(1):499. doi: 10.1186/s12872-026-05703-1.
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 Home-Based Telerehabilitation Cardiac Rehabilitation in people with Psychological Distress After Coronary Artery Bypass Grafting (CABG), 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 6 inclusion and 4 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 18 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 Anxiety Symptoms (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?
On the ClinicalTrials.gov record for NCT07232693, which also lists 1 linked publication.
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 18 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.