Cardiac DiseaseNCT06640699
The Effects of Neurophysiological Facilitation Techniques After Coronary Artery Bypass Graft Surgery
A study testing exercise in people with Cardiac Disease, run by Istanbul University - Cerrahpasa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time undergoing open-heart surgery
- Aged between 50 and 85 years
- Full cooperation
Who cannot join
- 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
Show all 9Show fewer
- Presence of orthopedic disabilities
- Intubation duration longer than 24 hours
- Staying in intensive care for more than 48 hours
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Disease
- Being tested
- exercise
- Keywords
- coronary artery bypass, respiratory function test, ventricular ejection fraction
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
exercises with using neurophysiological facilitation techniques and cardiac rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| NFT Group | Experimental | NFT group will receive Phase I cardiac rehabilitation and neurophysiological facilitation techniques. Receives: Other: exercise |
| Control Group | Active comparator | Control group will receive Phase I cardiac rehabilitation alone. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
ecocardiography device
ejection fraction will assess with ecocardiography.
Measured: 3 months
spirometer
respiratory function test will assess with spirometer
Measured: 3 months
6 Minutes walking test
functional capacity will assess with 6 minutes walk test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Principal investigator, Gamze Aydin, Istanbul University - Cerrahpasa
- Investigators
- Gamze Aydın, PhD, Principal investigator, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640699
- Sponsor's protocol ID
- IstanbulOkanUnive
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neurophysiological Facilitation Techniques on Cardiopulmonary Parameters After Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06640699
- Acronym / sponsor ID
- IstanbulOkanUnive
- Conditions
- Cardiac Disease
- Keywords
- coronary artery bypass, respiratory function test, ventricular ejection fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| NFT Group | Experimental | Other: exerciseNFT group will receive Phase I cardiac rehabilitation and neurophysiological facilitation techniques. |
| Control Group | Active comparator | Other: exerciseControl group will receive Phase I cardiac rehabilitation alone. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First-time undergoing open-heart surgery
- Aged between 50 and 85 years
- Full cooperation
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseexercises with using neurophysiological facilitation techniques and cardiac rehabilitation. | Other | Control Group, NFT Group |
Primary outcome
ecocardiography device
Time frame: 3 months
ejection fraction will assess with ecocardiography.
spirometer
Time frame: 3 months
respiratory function test will assess with spirometer
6 Minutes walking test
Time frame: 3 months
functional capacity will assess with 6 minutes walk test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiac Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze Aydın, PhD principal investigator
Okan University
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Cardiac Disease, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gamze Aydın, PhD (05377600256, gamze.tosun@okan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ecocardiography device (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.