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

NCT07544459 | Completed

• 1 other identifier: 202508-H-013
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 (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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Anxiety Symptoms

  Baseline and post-intervention (8 weeks).

• Change in Treatment Adherence Score

  Baseline and post-intervention (8 weeks).

• Change in Kinesiophobia Level

  Baseline and post-intervention (8 weeks).

• Change in Standard Deviation of Normal-to-Normal RR Intervals

  Baseline and post-intervention (8 weeks).

• Change in Standard Deviation of Average Normal-to-Normal RR Intervals in 5-minute Segments

  Baseline and post-intervention (8 weeks).

Study Arms (2)

observation group

EXPERIMENTAL

receiving combined MBSR and aerobic training

Behavioral: observation group

control group

NO INTERVENTION

receiving aerobic training only

Interventions

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

observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Linyi People's Hospital: lead

Study Sites (1)

Linyi People's Hospital

Linyi, Shandong, 276000, China

Location

MeSH Terms

Conditions

Coronary Disease; Kinesiophobia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: October 15, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 25, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)