The Effect of Neurophysiological Facilitation Techniques on Health Parameters in Early Stages After Open Heart Surgery
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
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
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedAugust 13, 2024
August 1, 2024
9 months
February 19, 2024
August 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
İnspiratory muscle strength
Maximum Inspiratory Pressure (MIP) - pressure
Before and after treatment on each day of treatment, up to 3 month
Expiratory muscle strength
Maximum Expiratory Pressure (MEP) - pressure
After and before treatment on each day of treatment, up to 3 month
2 Minute Walk Test
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)
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
Oxygen saturation
Before and after treatment on each day of treatment, up to 3 month
Respiratory frequency
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
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
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
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
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
Dyspnea
Before and after treatment on each day of treatment, up to 3 month
Study Arms (2)
Control Group
EXPERIMENTALPhase 1 cardiac rehabilitation
Study Group
ACTIVE COMPARATORNeurophysiological facilitation techniques in addition to phase 1 cardiac rehabilitation techniques
Interventions
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.
Eligibility Criteria
You may qualify if:
- Having open heart surgery for the first time,
- Being between the ages of 18-75,
- Being fully cooperative
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lokman Hekim Akay Hospital
Ankara, 06000, Turkey (Türkiye)
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Yasemin Cirak, Prof. Dr.
Istinye University
- STUDY DIRECTOR
Feyza merakli
Istinye University
Central Study Contacts
Gungor
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
February 19, 2024
First Posted
August 13, 2024
Study Start
January 1, 2024
Primary Completion
October 1, 2024
Study Completion
November 1, 2024
Last Updated
August 13, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will remain open for 1 year.
- Access Criteria
- To be a journal in Science Citation Index (SCI), Emerging Sources Citation Index (ESCI) categories
The study protocol, Informed Consent Form, Statistical Analysis Plan and Clinical Study Report will be shared upon request.