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Completed

NCT Number: NCT07544459

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

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).

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Key information

Conditions

Coronary Heart Disease Aerobic Training Anxiety Disorders Cardiovascular Diseases Coronary Disease Heart Diseases Kinesiophobia Mental Disorders Mindfulness-based Stress Reduction Myocardial Ischemia Percutaneous Coronary Intervention Phobic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linyi People's Hospital

Linyi, Shandong, 276000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Observation group

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Linyi People's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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