Coronary Heart DiseaseNCT07544459
Mindfulness-based Stress Reduction Combined With Aerobic Training in Cardiac Rehabilitation After Percutaneous Coronary Intervention: A Dual Impact on Kinesiophobia and Heart Rate Variability
A study testing observation group in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by Linyi People's Hospital at 1 site in China.
Trial summary
To evaluate the effectiveness of mindfulness-based stress reduction (MBSR) combined with aerobic training on treatment adherence, kinesiophobia, heart rate variability (HRV), exercise tolerance, and psychological stress response in patients with coronary heart disease (CHD) post-percutaneous coronary intervention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Percutaneous Coronary Intervention, Mindfulness-based Stress Reduction
- What is being tested?
- observation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 25 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of coronary heart disease (CHD)
- Successful percutaneous coronary intervention (PCI) procedure
- No contraindications to rehabilitation exercise
- Provision of written informed consent by the patient and their legal guardian
Who cannot join
- Coexisting severe organic disease (e.g., severe valvular disease, advanced kidney or liver failure)
- Malignancy (active or history of cancer within recent years)
- Cognitive impairment (sufficient to preclude understanding or compliance with mindfulness-based stress reduction or exercise instructions)
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effectiveness of mindfulness-based stress reduction (MBSR) combined with aerobic training on treatment adherence, kinesiophobia, heart rate variability (HRV), exercise tolerance, and psychological stress response in patients with coronary heart disease (CHD) post-percutaneous coronary intervention (PCI).
Post-PCI patients (n = 150) were randomly assigned to an observation group (receiving combined MBSR and aerobic training) and a control group (receiving aerobic training only). Treatment adherence, the Tampa Scale for Kinesiophobia-Heart (TSK-SV Heart), HRV parameters, exercise tolerance, and psychological stress responses were assessed before and after the intervention. Psychological assessments included the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS).
- Conditions
- Coronary Heart Disease, Percutaneous Coronary Intervention, Mindfulness-based Stress Reduction, Aerobic Training, Kinesiophobia
- Being tested
- observation group
- Medical subject headings
- Coronary Disease, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation groupBehavioural
Patients participated in 2-hour daily MBSR sessions conducted in a designated hospital rehabilitation room. After discharge, patients were instructed to continue weekly home-based practice for two months. The MBSR components included: (a) Mindful breathing: Conducted in a quiet, comfortable, and distraction-free environment with the patient seated upright, shoulders and neck relaxed. Patients were guided to focus on their breath, feeling the sensation of air flowing in and out, for 10 to 15 minutes per session, 2 to 3 times daily. If thoughts or emotions arose during the session, attention was gently redirected to the breath. (b) Mindfulness meditation: Also performed in a quiet setting, patients were guided to adopt an accepting attitude toward negative emotions without resistance or avoidance. The goal was to allow emotions to arise and naturally dissipate. Each session lasted 20 to 30 minutes, once or twice daily. (c) Body scanning: Patients were guided to assume a comfortable postu
| Study group | Role | What they receive |
|---|---|---|
| observation group | Experimental | receiving combined MBSR and aerobic training Receives: Behavioral: observation group |
| control group | No intervention | receiving aerobic training only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Symptoms
The SDS is a 20-item self-rating scale used to assess the severity of depressive symptoms. Each item is scored on a 4-point Likert scale. Total scores range from 20 to 80. Scores below 53 are considered normal; higher scores indicate more severe depression. The sample size calculation (n=150) was based on an estimated effect size (Cohen's d) of 0.54 for this measure.
Measured: Baseline (pre-intervention) and immediately post-intervention (after 8 weeks).
Secondary outcomes (5)
Change in Anxiety Symptoms
The SAS is a 20-item self-rating scale assessing anxiety severity. Scores range from 20 to 80. Scores below 50 are considered normal; higher scores reflect more severe anxiety.
Measured: Baseline and post-intervention (8 weeks).
Change in Treatment Adherence Score
Assessed using a self-developed questionnaire tailored to the combined MBSR and aerobic training protocol. The questionnaire covers medication adherence (6 items), exercise participation (4 items), mindfulness practice (5 items), and routine follow-up (5 items). Each item uses a 5-point Likert scale. Total scores range from 0 to 100, with higher scores indicating better adherence.
Measured: Baseline and post-intervention (8 weeks).
Change in Kinesiophobia Level
Measured using the Tampa Scale for Kinesiophobia-Heart (TSK-SV Heart). This 15-item scale includes domains of fear of injury, perceived decline in physical function, avoidance of physical activity, and perceived cardiac risk. Items are scored on a 4-point Likert scale (1=strongly disagree to 4=strongly agree). Total score >37 indicates clinically significant kinesiophobia. Higher scores indicate greater fear of movement.
Measured: Baseline and post-intervention (8 weeks).
Change in Standard Deviation of Normal-to-Normal RR Intervals
SDNN (ms) is a time-domain measure of HRV reflecting overall autonomic function. Measured using an electrocardiographic analyzer (ECG1200G) after 5 minutes of seated rest.
Measured: Baseline and post-intervention (8 weeks).
Change in Standard Deviation of Average Normal-to-Normal RR Intervals in 5-minute Segments
SDANN (ms) reflects long-term components of HRV. Measured using an electrocardiographic analyzer.
Measured: Baseline and post-intervention (8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Oct 2023
- Primary completion17 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linyi People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haifeng Fan, Linyi People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544459
- Sponsor's protocol ID
- 202508-H-013
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Stress Reduction Combined With Aerobic Training in Cardiac Rehabilitation After Percutaneous Coronary Intervention: A Dual Impact on Kinesiophobia and Heart Rate Variability
- ClinicalTrials.gov ID
- NCT07544459
- Acronym / sponsor ID
- 202508-H-013
- Conditions
- Coronary Heart Disease, Percutaneous Coronary Intervention, Mindfulness-based Stress Reduction, Aerobic Training, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Linyi People's HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 22 Apr 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.
To evaluate the effectiveness of mindfulness-based stress reduction (MBSR) combined with aerobic training on treatment adherence, kinesiophobia, heart rate variability (HRV), exercise tolerance, and psychological stress response in patients with coronary heart disease (CHD) post-percutaneous coronary intervention (PCI).
Post-PCI patients (n = 150) were randomly assigned to an observation group (receiving combined MBSR and aerobic training) and a control group (receiving aerobic training only). Treatment adherence, the Tampa Scale for Kinesiophobia-Heart (TSK-SV Heart), HRV parameters, exercise tolerance, and psychological stress responses were assessed before and after the intervention. Psychological assessments included the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | Experimental | Behavioral: observation groupreceiving combined MBSR and aerobic training |
| control group | No intervention | –receiving aerobic training only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of coronary heart disease (CHD)
- Successful percutaneous coronary intervention (PCI) procedure
- No contraindications to rehabilitation exercise
- Provision of written informed consent by the patient and their legal guardian
Key exclusion criteria (3 listed)
- Coexisting severe organic disease (e.g., severe valvular disease, advanced kidney or liver failure)
- Malignancy (active or history of cancer within recent years)
- Cognitive impairment (sufficient to preclude understanding or compliance with mindfulness-based stress reduction or exercise instructions)
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 |
|---|---|---|
| observation groupPatients participated in 2-hour daily MBSR sessions conducted in a designated hospital rehabilitation room. After discharge, patients were instructed to continue weekly home-based practice for two months. The MBSR components included: (a) Mindful breathing: Conducted in a quiet, comfortable, and distraction-free environment with the patient seated upright, shoulders and neck relaxed. Patients were guided to focus on their breath, feeling the sensation of air flowing in and out, for 10 to 15 minutes per session, 2 to 3 times daily. If thoughts or emotions arose during the session, attention was gently redirected to the breath. (b) Mindfulness meditation: Also performed in a quiet setting, patients were guided to adopt an accepting attitude toward negative emotions without resistance or avoidance. The goal was to allow emotions to arise and naturally dissipate. Each session lasted 20 to 30 minutes, once or twice daily. (c) Body scanning: Patients were guided to assume a comfortable postu | Behavioural | observation group |
Primary outcome
Change in Depression Symptoms
Time frame: Baseline (pre-intervention) and immediately post-intervention (after 8 weeks).
The SDS is a 20-item self-rating scale used to assess the severity of depressive symptoms. Each item is scored on a 4-point Likert scale. Total scores range from 20 to 80. Scores below 53 are considered normal; higher scores indicate more severe depression. The sample size calculation (n=150) was based on an estimated effect size (Cohen's d) of 0.54 for this measure.
5 secondary outcomes
Change in Anxiety Symptoms
Time frame: Baseline and post-intervention (8 weeks).
Change in Treatment Adherence Score
Time frame: Baseline and post-intervention (8 weeks).
Change in Kinesiophobia Level
Time frame: Baseline and post-intervention (8 weeks).
Change in Standard Deviation of Normal-to-Normal RR Intervals
Time frame: Baseline and post-intervention (8 weeks).
Change in Standard Deviation of Average Normal-to-Normal RR Intervals in 5-minute Segments
Time frame: Baseline and post-intervention (8 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 22 Apr 2026.
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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 observation group in people with Coronary Heart Disease and Percutaneous Coronary Intervention, run by Linyi People's Hospital 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 4 inclusion and 3 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 22 Apr 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?
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 Depression Symptoms (time frame: Baseline (pre-intervention) and immediately post-intervention (after 8 weeks).). 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 22 Apr 2026.