NCT07470034

Brief Summary

This study aims to investigate the effects of diaphragm relaxation technique on sleep quality and respiratory functions in patients who have undergone coronary artery bypass graft (CABG) surgery. Two groups will be formed in the study: one group will receive standard cardiac rehabilitation, while the other group will receive diaphragm relaxation technique in addition to this. Throughout the study, patients' respiratory functions, sleep quality, respiratory muscle strength, and pain levels will be measured. These measurements will be taken from the patients...

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 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

August 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 2, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Cardiac RehabilitationCoronary Artery Bypass

Outcome Measures

Primary Outcomes (4)

  • Pulmonary Function (Spirometry)

    FEV1/FVC ratio measured with a spirometer. Measurements are performed according to ATS/ERS guidelines.

    1 years

  • Sleep Quality (Pittsburgh Sleep Quality Index)

    sleep latency and daytime dysfunction evaluated using the Pittsburgh Sleep Quality Index.

    1 years

  • Respiratory Muscle Strength (MIP/MEP)

    Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured using an oral pressure device to evaluate respiratory muscle strength.

    1 years

  • Pain Level (Visual Analog Scale)

    Chest and incision site pain assessed using a 0-10 cm Visual Analog Scale (0 = no pain, 10 = worst pain imaginable). Measured during rest, activity, and night.

    1 years

Study Arms (2)

Diaphragm Release plus Standard Cardiac Rehabilitation

ACTIVE COMPARATOR

Standard in-hospital cardiac rehabilitation plus diaphragm release technique applied for a minimum of 5 days during hospitalization.

Other: Intervention Group

Standard In-Hospital Cardiac Rehabilitation

ACTIVE COMPARATOR

Standard in-hospital cardiac rehabilitation only.

Other: Control Group

Interventions

Participants receive standard in-hospital cardiac rehabilitation plus diaphragm release technique. The diaphragm release is performed daily during the hospital stay for a minimum o

Diaphragm Release plus Standard Cardiac Rehabilitation

Participants receive standard in-hospital cardiac rehabilitation only, including breathing exercises, mobilization, and post-operative physiotherapy, without diaphragm release.

Standard In-Hospital Cardiac Rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Age under 65 years
  • Undergoing minimally invasive coronary artery bypass graft (CABG) surgery
  • Hemodynamically stable
  • Ambulatory (able to walk)
  • Willing to participate in the study and provide written informed consent
  • Mini-Mental State Examination (MMSE) score ≥ 25

You may not qualify if:

  • History of cerebrovascular events (stroke, TIA)
  • Orthopedic problems preventing walking
  • Uncontrolled diabetes
  • Uncontrolled hypertension
  • Severe visual impairment
  • Other diseases limiting participation in exercise training (pulmonary, neurological, metabolic, etc.)
  • Verbal or auditory cooperation problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko Unıversıty

Gaziantep, şehitkamil, 27500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a two-arm interventional study designed to evaluate the effects of the diaphragm release technique on post-operative respiratory function and sleep quality in patients undergoing minimally invasive coronary artery bypass graft (CABG) surgery. Participants will be assigned to either: Intervention Group: Receives standard in-hospital cardiac rehabilitation plus diaphragm release technique during hospitalization (minimum 5 days). Control Group: Receives standard in-hospital cardiac rehabilitation only. The study follows a prospective, controlled design, with all interventions delivered according to a standardized protocol. Outcomes, including pulmonary function tests, respiratory muscle strength, sleep quality, and pain scores, will be measured at baseline and throughout the hospital stay. Data will be analyzed to compare the physiological and clinical effects between the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ass prof

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 13, 2026

Study Start

August 30, 2025

Primary Completion

January 15, 2026

Study Completion

February 15, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations