Open Heart SurgeryNCT06551714
The Effect of Neurophysiological Facilitation Techniques on Health Parameters in Early Stages After Open Heart Surgery
A study testing Phase 1 cardiac rehabilitation and Neurophysiological facilitation techniques in people with Open Heart Surgery and Cardiovascular Disease, run by Dogus Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Open Heart Surgery, Cardiovascular Disease, Physiotherapy
- What is being tested?
- Phase 1 cardiac rehabilitation and Neurophysiological facilitation techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Nov 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having open heart surgery for the first time,
- Being between the ages of 18-75,
- Being fully cooperative
Who cannot join
- 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,
Show all 9Show fewer
- Having an orthopedic disability,
- Intubation time longer than 24 hours,
- Staying in intensive care for more than 48 hours
Trial locations and contacts
1 site in 1 country.
Gungor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Lokman Hekim Akay Hospital
Ankara, 06000
Physiotherapist, 05427685223
Feyza meraklı
About this study
Official title: 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.
Read the 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).
- Conditions
- Open Heart Surgery, Cardiovascular Disease, Physiotherapy
- Being tested
- Phase 1 cardiac rehabilitation, Neurophysiological facilitation techniques
- Keywords
- Neurophysiological facilitation technique, Cardiac rehabilitation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 cardiac rehabilitationProcedure or surgery
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.
Neurophysiological facilitation techniquesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Phase 1 cardiac rehabilitation Receives: Procedure: Phase 1 cardiac rehabilitation |
| Study Group | Active comparator | Neurophysiological facilitation techniques in addition to phase 1 cardiac rehabilitation techniques Receives: Procedure: Phase 1 cardiac rehabilitation; Procedure: Neurophysiological facilitation techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
İnspiratory muscle strength
Maximum Inspiratory Pressure (MIP) - pressure
Measured: Before and after treatment on each day of treatment, up to 3 month
Expiratory muscle strength
Maximum Expiratory Pressure (MEP) - pressure
Measured: 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
Measured: 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
Measured: first day of treatment before treatment and last day of treatment after treatment, up to 3 month
Vital sign
Oxygen saturation
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after treatment on each day of treatment, up to 3 month
Life quality
The Minnesota Living with Heart Failure Questionnaire
Measured: 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
Measured: Before treatment on the first day of treatment and after treatment on last day of treatment, up to 3 month
Symptom
Dyspnea
Measured: Before and after treatment on each day of treatment, up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jan 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dogus Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Merakli, Dogus Universitesi
- Investigators
- Yasemin Cirak, Prof. Dr., Principal investigator, Istinye UniversityFeyza merakli, Study director, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551714
- Sponsor's protocol ID
- DogusU
- Status last verified
- Aug 2024
- First submitted
- 19 Feb 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, Informed Consent Form, Statistical Analysis Plan and Clinical Study Report will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neurophysiological Facilitation Techniques on Pulmonary Function, Respiratory Muscle Strength and Functional Capacity in The Early Stage After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06551714
- Acronym / sponsor ID
- DogusU
- Conditions
- Open Heart Surgery, Cardiovascular Disease, Physiotherapy
- Keywords
- Neurophysiological facilitation technique, Cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Dogus UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 Aug 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Procedure: Phase 1 cardiac rehabilitationPhase 1 cardiac rehabilitation |
| Study Group | Active comparator | Procedure: Phase 1 cardiac rehabilitation, Procedure: Neurophysiological facilitation techniquesNeurophysiological facilitation techniques in addition to phase 1 cardiac rehabilitation techniques |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having open heart surgery for the first time,
- Being between the ages of 18-75,
- Being fully cooperative
Key exclusion criteria (9 listed)
- 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,
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 |
|---|---|---|
| Phase 1 cardiac rehabilitationDay 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. | Procedure or surgery | Control Group, Study Group |
| Neurophysiological facilitation techniquesIn 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. | Procedure or surgery | Study Group |
Primary outcome
İnspiratory muscle strength
Time frame: Before and after treatment on each day of treatment, up to 3 month
Maximum Inspiratory Pressure (MIP) - pressure
Expiratory muscle strength
Time frame: After and before treatment on each day of treatment, up to 3 month
Maximum Expiratory Pressure (MEP) - pressure
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
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
Vital sign
Time frame: Before and after treatment on each day of treatment, up to 3 month
Oxygen saturation
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
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
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
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
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
Symptom
Time frame: Before and after treatment on each day of treatment, up to 3 month
Dyspnea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. The study protocol, Informed Consent Form, Statistical Analysis Plan and Clinical Study Report will be shared upon request.
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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.
Gungor contact
Yasemin Cirak, Prof. Dr. principal investigator
Istinye University
Feyza merakli study director
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1 cardiac rehabilitation and Neurophysiological facilitation techniques in people with Open Heart Surgery and Cardiovascular Disease, run by Dogus Universitesi at 1 site in Turkey (Türkiye).
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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Feyza merakli (05427685223 ext. 0606, feyzamrkl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
İnspiratory muscle strength (time frame: Before and after treatment on each day of treatment, up to 3 month). The study lists 11 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 13 Aug 2024.