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).

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Percutaneous Coronary Intervention; Kinesiophobia; Mindfulness-based Stress Reduction; Aerobic Training
• Intervention / Treatment: Behavioral: observation group

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-intervention) and immediately post-intervention (after 8 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline and post-intervention (8 weeks).

Collaborators and Investigators

• Sponsor: Linyi People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): January 25, 2025

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Heart Diseases; Myocardial Ischemia; Phobic Disorders; Anxiety Disorders; Kinesiophobia; Coronary Disease
• Other Study ID 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