- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06640699
The Effects of Neurophysiological Facilitation Techniques After Coronary Artery Bypass Graft Surgery
October 11, 2024 updated by: Gamze Aydin, Istanbul University - Cerrahpasa (IUC)
The Effects of Neurophysiological Facilitation Techniques on Cardiopulmonary Parameters After Coronary Artery Bypass Graft Surgery
The aim of the study is to investigate the effects of neurophysiological facilitation techniques, applied in addition to Phase I cardiac rehabilitation in the early postoperative period after coronary artery bypass graft (CABG) surgery, on left ventricular function, respiratory functions, and functional capacity.
Study Overview
Detailed Description
In this prospective randomized controlled study, participants will be randomly divided into two groups: the control group, which will receive Phase I cardiac rehabilitation, and the treatment group, which will receive Phase I cardiac rehabilitation along with the application of neurophysiological facilitation techniques.
The participants' left ventricular function, respiratory functions, and functional capacity will be assessed before and after the interventions.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gamze Aydın, PhD
- Phone Number: 05377600256
- Email: gamze.tosun@okan.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- First-time undergoing open-heart surgery
- Aged between 50 and 85 years
- Full cooperation
Exclusion Criteria:
- Presence of facial, sternum, or rib fractures
- Chronic renal failure
- Development of cerebrovascular events
- Cognitive function impairment
- Development of deep vein thrombosis in the postoperative period
- Presence of neuromuscular disease
- Presence of orthopedic disabilities
- Intubation duration longer than 24 hours
- Staying in intensive care for more than 48 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NFT Group
NFT group will receive Phase I cardiac rehabilitation and neurophysiological facilitation techniques.
|
exercises with using neurophysiological facilitation techniques and cardiac rehabilitation.
|
|
Active Comparator: Control Group
Control group will receive Phase I cardiac rehabilitation alone.
|
exercises with using neurophysiological facilitation techniques and cardiac rehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ecocardiography device
Time Frame: 3 months
|
ejection fraction will assess with ecocardiography.
|
3 months
|
|
spirometer
Time Frame: 3 months
|
respiratory function test will assess with spirometer
|
3 months
|
|
6 Minutes walking test
Time Frame: 3 months
|
functional capacity will assess with 6 minutes walk test.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gamze Aydın, PhD, Okan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
October 9, 2024
First Submitted That Met QC Criteria
October 11, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 11, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulOkanUnive
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.