Mindfulness-based Stress Reduction Combined With Aerobic Training in Cardiac Rehabilitation After Percutaneous Coronary Intervention: A Dual Impact on Kinesiophobia and Heart Rate Variability

April 15, 2026 updated by: Haifeng Fan, Linyi People's Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Linyi, Shandong, China, 276000
        • Linyi People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: observation group
receiving combined MBSR and aerobic training
Behavioral: observation group
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
No Intervention: control group
receiving aerobic training only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-intervention) and immediately post-intervention (after 8 weeks).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Anxiety Symptoms
Time Frame: Baseline and post-intervention (8 weeks).
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.
Baseline and post-intervention (8 weeks).
Change in Treatment Adherence Score
Time Frame: Baseline and post-intervention (8 weeks).
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.
Baseline and post-intervention (8 weeks).
Change in Kinesiophobia Level
Time Frame: Baseline and post-intervention (8 weeks).
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.
Baseline and post-intervention (8 weeks).
Change in Standard Deviation of Normal-to-Normal RR Intervals
Time Frame: Baseline and post-intervention (8 weeks).
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.
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).
SDANN (ms) reflects long-term components of HRV. Measured using an electrocardiographic analyzer.
Baseline and post-intervention (8 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linyi People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202508-H-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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