NCT07006441

Brief Summary

This randomized controlled trial investigates the comparative effects of a combined preoperative and postoperative cardiac rehabilitation program versus a postoperative-only program on functional capacity, pulmonary function, peripheral muscle strength, pain, kinesiophobia, and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery. The study aims to determine whether initiating rehabilitation prior to surgery improves short-term postoperative outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

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

August 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

May 28, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

Coronary Artery DiseaseCoronary Artery Bypass Graft SurgeryPreoperative Cardiac RehabilitationPostoperative Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (8)

  • Forced Vital Capacity (FVC)

    Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.

    2 weeks

  • Forced Expiratory Volume in 1 second (FEV1)

    Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.

    2 weeks

  • Peak Expiratory Flow (PEF)

    Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.

    2 weeks

  • Forced Expiratory Flow 25-75% (FEF25-75)

    Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.

    2 weeks

  • 6-minute Walk Test

    The 6-minute Walk Test will be performed according to ATS guidelines. Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.

    2 weeks

  • M. Quadriceps Muscle Strength

    The m. quadriceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA). The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.

    2 weeks

  • M. Biceps Muscle Strength

    The m. biceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA). The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.

    2 weeks

  • Cough Peak Flow

    Cough Peak Flow (CPF) will be measured using a peak expiratory flow meter. Participants will be instructed to take a maximal deep breath and then cough as forcefully as possible into the device; the highest value from three trials will be recorded in liters per minute (L/min). Measurements will be performed in a seated position, ensuring a tight mouth seal and consistent technique.

    2 weeks

Secondary Outcomes (3)

  • Level of Pain

    2 weeks

  • Level of Fear of Movement

    2 weeks

  • Level of Quality of Life

    2 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Preoperative cardiac rehabilitation + postoperative cardiac rehabilitation (structured exercise, respiratory physiotherapy, and patient education)

Other: Preoperative Cardiac RehabilitationOther: Postoperative Cardiac Rehabilitation

Control Group

ACTIVE COMPARATOR

Postoperative cardiac rehabilitation (structured exercise, respiratory physiotherapy, and patient education)

Other: Postoperative Cardiac Rehabilitation

Interventions

Structured exercise program, respiratory physiotherapy, and patient education

Experimental Group

Structured exercise program, respiratory physiotherapy, and patient education

Control GroupExperimental Group

Eligibility Criteria

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

You may qualify if:

  • Having undergone coronary artery bypass graft surgery
  • Ejection Fraction (EF) \> 40%
  • Being between the ages of 18-65
  • Being able to speak, read and understand in their own language
  • Volunteering to participate in the study

You may not qualify if:

  • Having an active or suspected infection
  • Presence of an active tumour
  • History of thrombophlebitis or pulmonary embolism within the last 3 months
  • Having an orthopaedic, neurological or cardiovascular disease that may affect the assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hikmet Ucgun, PT, PhD

    Atlas University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

August 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations