NCT06970938

Brief Summary

This study aimed to evaluate the effects of cardiac rehabilitation program after CABG surgery on quality of life, sleep quality, anxiety, depression and cardiopulmonary functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 5, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Evaluation of quality of life of groups

    SF-36 quality of life scale: Contains 36 items. Measurement of 8 dimensions is provided. These dimensions are: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain and general health perception.

    ıt ranges from 3 months to 6 months

  • Evaluation of sleep quality of groups

    Pittsburgh Sleep Quality Index: Contains 24 questions in total. 19 of these are self-report questions. Five questions are answered by the spouse or a roommate and are used for clinical information only. They are not included in the scoring. It has seven components. These components are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. Each item is scored between 0-3. A total score of 5 or higher indicates poor sleep quality.

    ıt ranges 3 months to 6 months

  • Evaluation of depression and anxiety of groups

    Beck Depression Scale: Consists of 21 questions. Each question has 4 answer options scored between 0 and 3. A total score between 0-13 indicates no depression, 14-19 indicates mild depression, 20-18 indicates moderate depression, and 29-63 indicates severe depression. Beck Anxiety Scale: Consists of 21 questions. Questions are scored between 0-3. The minimum score on the scale is 0, the maximum score is 63. Increasing scores on the scale indicate an increase in the anxiety level.

    ıt ranges 3 months to 6 months

  • Evaluation of cardiopulmonary functions of groups

    6-minute walking test: It is applied in a 30-meter corridor in a closed environment. The distance the patient walks in six minutes, oxygen saturation, heart rate, and changes in dyspnea are recorded. FEV1, FVC and FEV1/FVC values with respiratory function test, echo test for ejection fraction, blood test for LDL values, height and weight values for body mass index

    ıt ranges 3 months to 6 months

Study Arms (2)

Comparison of the effects of cardiac rehabilitation programs on patient outcomes

EXPERIMENTAL

The experimental group patients were included in the cardiac rehabilitation program. The cardiac rehabilitation program was implemented in the cardiopulmonary rehabilitation unit with bicycle ergometry devices by a team consisting of a physical medicine and rehabilitation physician, physiotherapist and nurse. The target heart rate that could be achieved during exercise was determined according to the patient's age and the medications he/she used. The exercise intensity was planned as low and moderate according to the target heart rate percentage. The program was organized as 30 sessions, 5 days a week, for 6 weeks. The sessions were implemented for half an hour while the patients were monitored from the bicycle ergometry device.

Other: Cardiac rehabilitation program

Comparison of the effects of standard care on patient outcomes

NO INTERVENTION

The control group patients were not subjected to any program other than the training they received upon discharge, which was the routine operation of the clinics.

Interventions

The experimental group patients were included in the cardiac rehabilitation program. The cardiac rehabilitation program was implemented in the cardiopulmonary rehabilitation unit with bicycle ergometry devices by a team consisting of a physical medicine and rehabilitation physician, physiotherapist and nurse. The target heart rate that could be achieved during exercise was determined according to the patient's age and the medications he/she used. The exercise intensity was planned as low and moderate according to the target heart rate percentage. The program was organized as 30 sessions, 5 days a week, for 6 weeks. The sessions were implemented for half an hour while the patients were monitored from the bicycle ergometry device.

Also known as: rehabilitation program
Comparison of the effects of cardiac rehabilitation programs on patient outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients who had isolated CABG surgery 3 months ago, patients with EF 50% and above, patients who are eligible for the CR program, patients who agree to participate in the study, patients who are 18 years of age and above

You may not qualify if:

  • Patients who did not consent to participate in the study, patients who had emergency CABG surgery, patients who had minimally invasive CABG surgery, patients who had repeat cardiac surgery, patients with a disease that was not suitable for the CR program (e.g., stage IV heart failure, unstable angina), patients with EF \< 50%, patients with a psychiatric diagnosis and patients using medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

May 5, 2025

First Posted

May 14, 2025

Study Start

January 1, 2025

Primary Completion

April 29, 2025

Study Completion

April 29, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations