The Effect of Neurophysiological Facilitation Techniques on Health Parameters in Early Stages After Open Heart Surgery

August 9, 2024 updated by: Feyza Merakli, Dogus Universitesi

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

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

Interventional

Enrollment (Estimated)

32

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

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

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:

  • 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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yasemin Cirak, Prof. Dr., Istinye University
  • Study Director: Feyza merakli, Istinye 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 (Actual)

January 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

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)?

YES

IPD Plan Description

The study protocol, Informed Consent Form, Statistical Analysis Plan and Clinical Study Report will be shared upon request.

IPD Sharing Time Frame

Data will remain open for 1 year.

IPD Sharing Access Criteria

To be a journal in Science Citation Index (SCI), Emerging Sources Citation Index (ESCI) categories

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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.

Clinical Trials on Cardiovascular Disease

Clinical Trials on Phase 1 cardiac rehabilitation

Subscribe