- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06551714
The Effect of Neurophysiological Facilitation Techniques on Health Parameters in Early Stages After Open Heart Surgery
The Effect of Neurophysiological Facilitation Techniques on Pulmonary Function, Respiratory Muscle Strength and Functional Capacity in The Early Stage After Open Heart Surgery
In this study, researchers aimed to investigate effects of neurophysiological facilitation on functional capacity and respiratory parameters of patients who underwent open heart surgery.
Do neurophysiological facilitation techniques improve individuals' respiratory parameters more than phase 1 cardiac rehabilitation?
Do neurophysiological facilitation techniques improve individuals' functional capacity more than phase 1 cardiac rehabilitation?
Researchers will apply phase 1 cardiac rehabilitation to both groups to see the effectiveness of neurophysiological facilitation techniques.
Study Overview
Status
Intervention / Treatment
Detailed Description
In this study, researchers aimed to investigate effects of neurophysiological facilitation on functional capacity and respiratory parameters of patients who underwent open heart surgery.
The study was performed on 32 patients who underwent open heart surgery. Patients divided into two groups which study group (n=18) and control group (n=14).
Range of motion, breathing and mobilization exercises within the scope of phase 1 cardiac rehabilitation program were applied to the control group; in addition to the phase 1 cardiac rehabilitation program, neurophysiological facilitation techniques (perioral stimulation, intercostal tension, anterior basal lift, vertebral pressure, moderate manual pressure and abdominal co-contraction) were applied to the study group.
Sociodemographic features and disease-specific findings were recorded on the first postoperative day .
Vital signs, functional capacity, pulmonary function, fatigue and dyspnea of every patient were recorded before and after each treatment on the first four postoperative days.
Functional capacity was evaluated using Timed Up and Go (TUG) test and 2-Minutes Walking test (2MWT). Pulmonary function was examined using a peak flow meter and respiratory muscle strength was measured using an intraoral pressure measurement device. In addition, fatigue and dyspnea perception was measured using Modified Borg Scale.
Before the first day treatment and after the last day treatment of the four-day treatment, patients' fatigue severity were assessed with using Fatigue Severity Scale (FSS), anxiety and depression level with using Hospital Anxiety Depression Scale (HADS), fear of movement with using TAMPA Kinesiophobia Scale and life quality with using the Minnesota Heart Failure Questionnaire.
Before each treatment chest circumference measurements were taken, and the perceived pain severity was recorded using Visual Analog Scale (VAS).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Feyza merakli
- Phone Number: 0606 05427685223
- Email: feyzamrkl@gmail.com
Study Contact Backup
- Name: Gungor
Study Locations
-
-
-
Ankara, Turkey, 06000
- Recruiting
- Lokman Hekim Akay Hospital
-
Contact:
- Physiotherapist
- Phone Number: 05427685223
-
Principal Investigator:
- Feyza meraklı
-
Sub-Investigator:
- Yasemin Buran Çırak
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having open heart surgery for the first time,
- Being between the ages of 18-75,
- Being fully cooperative
Exclusion Criteria:
- Having facial, sternum and rib fractures,
- Having chronic renal failure,
- Development of cerebrovascular accident,
- Having cognitive dysfunction,
- Development of deep vein thrombosis in the post-operative period,
- Having neuromuscular disease,
- Having an orthopedic disability,
- Intubation time longer than 24 hours,
- Staying in intensive care for more than 48 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
Phase 1 cardiac rehabilitation
|
Day 1:Patients were informed about the surgery, positioning and mobilization.Range of motion (ROM), respiratory control, diaphragmatic breathing, pursed lip breathing, thoracal expansion exercises, assisted coughing,forced expiration techniques, which are the components of active breathing techniques cycle (ABTC), were taught.The use of incentive spirometry (IS) was demonstrated.Patients were performed 10 repetitions of IS exercises, and 5 repetitions ABTC and were asked to repeat them every hour.The patient was made to sit for 10 minutes and was walked 60 meters twice a day. 2:ROM, IS and diaphragmatic breathing exercises were applied 10 times each.ABTC was repeated in 5 sets. 120 meters was walked 5 times during the day. 3:Sitting time was increased to 30 minutes and walking distance was increased to 240 meters.5 steps were climbed. 4:Walking distance was increased to 360 meters.One flight of stairs was climbed.Discharge training was given. |
|
Active Comparator: Study Group
Neurophysiological facilitation techniques in addition to phase 1 cardiac rehabilitation techniques
|
Day 1:Patients were informed about the surgery, positioning and mobilization.Range of motion (ROM), respiratory control, diaphragmatic breathing, pursed lip breathing, thoracal expansion exercises, assisted coughing,forced expiration techniques, which are the components of active breathing techniques cycle (ABTC), were taught.The use of incentive spirometry (IS) was demonstrated.Patients were performed 10 repetitions of IS exercises, and 5 repetitions ABTC and were asked to repeat them every hour.The patient was made to sit for 10 minutes and was walked 60 meters twice a day. 2:ROM, IS and diaphragmatic breathing exercises were applied 10 times each.ABTC was repeated in 5 sets. 120 meters was walked 5 times during the day. 3:Sitting time was increased to 30 minutes and walking distance was increased to 240 meters.5 steps were climbed. 4:Walking distance was increased to 360 meters.One flight of stairs was climbed.Discharge training was given. In addition to the phase 1 cardiac rehabilitation program for the group receiving neurophysiological facilitation (NPF) techniques: NPF techniques such as perioral stimulation, intercostal tension, anterior basal lift, vertebral pressure, moderate manual pressure and abdominal co-contraction were applied for ten times for ten seconds. Diaphragm facilitation exercise was performed by inhaling against resistance and holding the breath against resistance for 5 seconds. Unilateral and bilateral upper extremity proprioceptive neuromuscular facilitation (PNF) movements combined with breathing were performed. NPF techniques were performed 10 times each day throughout the treatment, while other applications (diaphragm facilitation, combined breathing exercise with upper extremity PNF technique and respiratory facilitation) were performed 5 times on the first day and 10 times on the other three days. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
İnspiratory muscle strength
Time Frame: Before and after treatment on each day of treatment, up to 3 month
|
Maximum Inspiratory Pressure (MIP) - pressure
|
Before and after treatment on each day of treatment, up to 3 month
|
|
Expiratory muscle strength
Time Frame: After and before treatment on each day of treatment, up to 3 month
|
Maximum Expiratory Pressure (MEP) - pressure
|
After and before treatment on each day of treatment, up to 3 month
|
|
2 Minute Walk Test
Time Frame: Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month
|
It is walking as fast as the person can for 2 minutes without any assistance, at a safe distance of 30 meters.
- meter
|
Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month
|
|
Time Up and Go (TUG)
Time Frame: first day of treatment before treatment and last day of treatment after treatment, up to 3 month
|
The person gets up from the chair, walks 3 meters, comes back and sits on the chair.
- minute
|
first day of treatment before treatment and last day of treatment after treatment, up to 3 month
|
|
Vital sign
Time Frame: Before and after treatment on each day of treatment, up to 3 month
|
Oxygen saturation
|
Before and after treatment on each day of treatment, up to 3 month
|
|
Respiratory frequency
Time Frame: Before and after treatment on each day, up to 3 month
|
Number of times a person inhales and exhales in 1 minute.
- number
|
Before and after treatment on each day, up to 3 month
|
|
Blood pressure
Time Frame: Before and after treatment on day of treatment, up to 3 month
|
Blood pressure is the pressure of blood within the arteries of the circulatory system.
- pressure
|
Before and after treatment on day of treatment, up to 3 month
|
|
Heart rate
Time Frame: Before and after treatment on each day of treatment, up to 3 month
|
Number of times a person heart rate in 1 minute.
- number
|
Before and after treatment on each day of treatment, up to 3 month
|
|
Life quality
Time Frame: Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month
|
The Minnesota Living with Heart Failure Questionnaire
|
Before treatment on the first day of treatment and after treatment on the last day of treatment, up to 3 month
|
|
Depression
Time Frame: Before treatment on the first day of treatment and after treatment on last day of treatment, up to 3 month
|
Beck's depression inventory
|
Before treatment on the first day of treatment and after treatment on last day of treatment, up to 3 month
|
|
Symptom
Time Frame: Before and after treatment on each day of treatment, up to 3 month
|
Dyspnea
|
Before and after treatment on each day of treatment, up to 3 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yasemin Cirak, Prof. Dr., Istinye University
- Study Director: Feyza merakli, Istinye University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DogusU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingCardiovascular Disease (CVD) | Gender Incongruence | Cardiovascular (CV) Risk | Cardiovascular Health Status | Cardiovascular Disease Prevention | Cardiovascular Disease Acute | Cardiovascular Disease Risk FactorItaly
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
University College DublinBeacon Hospital, IrelandRecruitingCoronary Artery Disease (CAD) | Cardiovascular Diseases (CVD) | Cardiovascular Disease Prevention | Cardiovascular Disease Risk FactorIreland
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Istituti Clinici Scientifici Maugeri SpAA.R.C.A Associazioni Regionali Cardiologi AmbulatorialiRecruiting
-
AmgenRecruitingCardiovascular DiseaseItaly, Germany, United States, China, Japan, Spain, Denmark, Australia, France, Canada, Netherlands
-
University of ReadingBiotechnology and Biological Sciences Research Council; Royal Berkshire NHS...Not yet recruiting
-
Nanjing Medical UniversityRecruiting
-
Centre Hospitalier Universitaire de la RéunionRecruitingCardiovascular DiseaseFrance
Clinical Trials on Phase 1 cardiac rehabilitation
-
Riphah International UniversityCompletedCoronary Artery DiseasePakistan
-
Riphah International UniversityCompletedCardiovascular DiseasesPakistan
-
Ant ShepherdHampshire Hospitals NHS Foundation TrustUnknown
-
Hanoi Medical UniversityNot yet recruitingValvular DiseasesVietnam
-
Taipei Medical University WanFang HospitalCompletedAcute Myocardial InfarctionTaiwan
-
Dokuz Eylul UniversityCompleted
-
National Heart and Lung InstituteRoyal Brompton & Harefield NHS Foundation TrustCompletedMicrovascular AnginaUnited Kingdom
-
Riphah International UniversityRecruitingCoronary Artery StenosisPakistan
-
José Manuel Afonso MoreiraCompletedMyocardial Ischemia | Heart DiseasesPortugal
-
Universiti Putra MalaysiaCompletedDepression | Anxiety | Health Status | 90-day ReadmissionJordan