NCT07468955

Brief Summary

Objective: This study aimed to retrospectively evaluate the impact of cardiac rehabilitation (CR) on functional capacity, depressive symptoms, health-related quality of life, and sleep quality in patients with heart disease. Methods: A retrospective analysis was conducted on patients who participated in a structured CR program. Clinical records were reviewed to compare pre- and post-rehabilitation outcomes. Functional capacity was assessed using the 6-Minute Walk Test (6MWT), while depressive symptoms, health-related quality of life, and sleep quality were evaluated using the Beck Depression Inventory (BDI), the Short Form-36 (SF-36), and the Pittsburgh Sleep Quality Index (PSQI), respectively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

4.3 years

First QC Date

March 9, 2026

Last Update Submit

July 29, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Functional Capacity

    unctional capacity is assessed using the 6-Minute Walk Test (6MWT). The distance walked in 6 minutes is recorded in meters. An increase in distance indicates improved functional exercise capacity.

    Baseline and post-intervention (6 week later)

  • Change in Depressive Symptom

    Assessed using the Beck Depression Inventory (BDI). The BDI is a 21-item self-report scale. Scores range from 0 to 63, where higher scores indicate more severe depressive symptoms.

    Baseline and post-intervention (6 week later)

  • Change in Quality of Life

    Assessed using the Short Form-36 (SF-36) Health Survey. It consists of 36 items covering 8 dimensions of health. Scores range from 0 to 100 for each subscale, with higher scores representing better health status.

    Baseline and post-intervention (6 week later)

  • Change in Sleep Quality

    Assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 individual items generating 7 component scores. The global score ranges from 0 to 21; higher scores indicate poorer sleep quality (scores \>5 suggest significant sleep disturbance).

    Baseline and post-intervention (6 week later)

Study Arms (1)

Cardiac Rehabilitation Group

EXPERIMENTAL

Patients in this group participated in a structured, multidisciplinary cardiac rehabilitation program. The intervention included individualized aerobic exercise training, resistance exercises, patient education, and psychosocial counseling.

Other: Exercise Based Cardiac Rehabilitation

Interventions

The intervention consists of a structured, exercise-based cardiac rehabilitation (CR) program. The exercise protocol was tailored to each patient's clinical status and typically included aerobic endurance training complemented by resistance training for major muscle groups. Each session lasted approximately 40-60 minutes, consisting of a 10-minute warm-up, 20-40 minutes of moderate-intensity aerobic activity or high-intensity interval training (1:1 ratio), and a 10-minute cool-down period.

Cardiac Rehabilitation Group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with coronary artery disease (CAD), status post-myocardial infarction (MI), stable angina, or those who have undergone cardiac surgery
  • Availability of complete pre- and post-rehabilitation clinical records, including 6-Minute Walk Test (6MWT), BDI, SF-36, and PSQI scores.
  • Patients classified as stable by a cardiologist prior to the initiation of the exercise program.

You may not qualify if:

  • Presence of severe orthopedic, neurological, or musculoskeletal disorders that prevent the performance of the 6-Minute Walk Test or exercise training.
  • Patients with severe cognitive impairment
  • Unstable angina pectoris, uncontrolled arrhythmias, or advanced heart failure (NYHA Class IV) that contraindicates aerobic exercise.
  • Patients who dropped out of the rehabilitation program before completion or had more than a 20% absence rate in sessions.
  • Patients who underwent major non-cardiac surgery within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Şehir Hastanesi Yoncalı Yerleşkesi

Kütahya, Center, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assit. Prof.

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

July 14, 2019

Primary Completion

October 30, 2023

Study Completion

March 8, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policies regarding data privacy and the protection of sensitive patient information under national data protection laws.

Locations