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The Effect of Proprioceptive Neuromuscular Facilitation (PNF) Technique for Children With Chronic Pulmonary Diseases.

Primary Purpose

Chronic Respiratory Disease, Cystic Fibrosis, Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group applying PNF technique
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Respiratory Disease focused on measuring proprioceptive neuromuscular facilitation, respiratory functions, elastic band, posture

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients between the ages of 10-18 years
  2. Walking alone
  3. The children with chronic pulmonary diseases who can cooperate
  4. Children who can accommodate to the programme
  5. The family who gave informed consent
  6. The children who are didn't at the acute exacerbation attack.

Exclusion Criteria:

  1. The children can't walk alone
  2. The children with chronic pulmonary diseases who can't cooperate
  3. The family who didn't gave informed consent
  4. The children who are at the acute exacerbation attack.

Sites / Locations

  • Gamze Baskent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group applying PNF technique

Home Programme

Arm Description

The experimental goup who are applying PNF technique with elastic bands for the upper extremities. Before the group will perform stretching and resisted exercises at the warming up period, after they will do PNF exercises with elastic bands on two PNF pattern for the upper extremities and finally they will do some stretching exercises for the cool down period. The programme will continue for 30-45 minutes, three times a week, for 12 weeks. They will work one by one with a physical therapist.

This group will perform only breathing exercises daily at home during 12 weeks.

Outcomes

Primary Outcome Measures

Pulmonary function test
This test evaluates respiratory functions. Dynamic pulmonary volumes will evaluate.

Secondary Outcome Measures

Posture Analysis
Plonk image measurement system is a posture analysis method evaluated on the computer software programme. We place the markers on the anatomic points of the body. We take a Picture with the camera. There is a 3 meter distance with the camera and the child. We take a Picture three times on the sagittal, frontal and lateral side.
6 Minutes Walk Test
This test was used to evaluate functional capacity. They are walking during six minutes on the corridor of 30 m. İf there is a fatigue they can have a rest. And they can continue to walk. We have to measure the distance of walking during six minutes. Before and after the test we have to measure the dyspnea and level of fatigue with perceived exertion scale.
6 Minutes Pegboard and Ring Test
İt measures functional capacity on the upper extremities of the body. Briefly, subjects were asked to move as many rings (each ring weighed 50 g; Zhan et al had used rings weighing half an ounce) as possible in 6 minutes, and the score was the number of rings moved during the 6-minute period. Pulse oxygen saturation was measured during the test. Scores for dyspnea were evaluated using a modified perceived exertion scale (0-10)13 immediately after the test.
The Pediatric Quality of Life Inventory (PedsQ-L)test
This was used to measure quality of life for children. There are subgroups measuring physically, social, sensory and the problems living at school.
Muscle testing
Muscle testing with the hand held dynamometer. Upper extremity muscle force will evaluate with the dynamometer.
Maximal inspiratory pressure and Maximal expiratory pressure measurement
Maximal inspiratory pressure and Maximal expiratory pressure will measure the respiratory muscle force with the Micro respiratory pressure measure.
Glitter-Activity of Daily Living test, Activity of Daily living measurement
In this test the patient reports the activities that promote discomfort during daily living activities. During its execution, functional capacity is evaluated by the time spent to perform a circuit that consists of global activities as walking, climbing up-and-down stairs, and trunk and upper limbs movements. The lower time spent the better is the functional condition. This test will measure functional capacity and easy to use.

Full Information

First Posted
January 27, 2018
Last Updated
February 28, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT03420209
Brief Title
The Effect of Proprioceptive Neuromuscular Facilitation (PNF) Technique for Children With Chronic Pulmonary Diseases.
Official Title
The Effect of Proprioceptive Neuromuscular Facilitation Technique on Respiratory Functions, Functional Capacity, Muscle Force, Posture, Activity of Daily Living, Quality of Life for Children With Chronic Pulmonary Diseases.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cystic fibrosis and bronchiectasis are the most seen problems in children with chronic pulmonary diseases. İt is a genetic, chronic system disease that reduces life expectancy, and life quality as well. Chronic lung disease , malnutrition, and reduced activity, caused by disease lead to postural disorders. Muscle force, endurance, activity of Daily living are adversely affected. İn the treatment pulmonary rehabilitation are using. Airway clearance technique, pulmonary exercises, upper extremity ergometer, dumbbells, elastic bands, proprioceptive neuromuscular facilitation technique are applying. Resistance training using elastic bands has become an increasingly common intervention aiming to improve function by increasing muscular strength. İn one study indicated that muscle strength can be improved through three dimensional spiral large scale resistive exercises using proprioceptive neuromuscular facilitation. İn the literature there isn't any research , uses elastic bands with proprioceptive neuromuscular facilitation for the upper extremity and evaluating pulmonary functions, posture, quality of life, muscle force. The aim of this study is giving exercises programme with proprioceptive neuromuscular facilitation and elastic bands and to evaluate pulmonary muscle force, pulmonary functions, posture, activity of daily living, quality of life, functional capacity. And to evaluate the effect of treatment programme on these parameters. The subjects were divided in two groups. An experimental group three times a week for 12 weeks will perform proprioceptive neuromuscular facilitation exercises with elastic bands, and pulmonary exercises. The control group will apply only pulmonary exercises at home programme.
Detailed Description
Participants: All participants with chronic respiratory disease were recruited from a Istanbul University Medical Faculty, Allergy Department. All treatments were performed in the same hospital. Sample Size: Sample size was calculated with power analysis. Pass 11 Home programme was used. α=0,05, β=0,6, 1- β=0,94 was determined. İf Sample size was defined 20 experimental and 20 control group the power obtained %95. Using two-sided two sample t-test with alpha 0,05 standard deviations were 5,0 and 4,0. Procedure: Forty chronic respiratory disease patient were assessed between the age of 10-18 years old. The patients were found to be suitable for inclusion criteria of the study.Randomisation was performed by using randomisation function of Microsoft Office Excel programme by another researcher (ARO). Random number generator of Microsoft Office Excel Software gave a random number between 0 and 1 to the each treatment columns which were created by ARO. Sorting the random number row from the largest to the smallest number was performed by the sort and filter menu.After the randomisation,assessments at baseline and the patients were divided two groups. The experimental group was treated one by one with one physical therapist three times a week during a session for 30-45 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Disease, Cystic Fibrosis, Bronchiectasis
Keywords
proprioceptive neuromuscular facilitation, respiratory functions, elastic band, posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group applying PNF technique
Arm Type
Experimental
Arm Description
The experimental goup who are applying PNF technique with elastic bands for the upper extremities. Before the group will perform stretching and resisted exercises at the warming up period, after they will do PNF exercises with elastic bands on two PNF pattern for the upper extremities and finally they will do some stretching exercises for the cool down period. The programme will continue for 30-45 minutes, three times a week, for 12 weeks. They will work one by one with a physical therapist.
Arm Title
Home Programme
Arm Type
No Intervention
Arm Description
This group will perform only breathing exercises daily at home during 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group applying PNF technique
Primary Outcome Measure Information:
Title
Pulmonary function test
Description
This test evaluates respiratory functions. Dynamic pulmonary volumes will evaluate.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Posture Analysis
Description
Plonk image measurement system is a posture analysis method evaluated on the computer software programme. We place the markers on the anatomic points of the body. We take a Picture with the camera. There is a 3 meter distance with the camera and the child. We take a Picture three times on the sagittal, frontal and lateral side.
Time Frame
12 weeks
Title
6 Minutes Walk Test
Description
This test was used to evaluate functional capacity. They are walking during six minutes on the corridor of 30 m. İf there is a fatigue they can have a rest. And they can continue to walk. We have to measure the distance of walking during six minutes. Before and after the test we have to measure the dyspnea and level of fatigue with perceived exertion scale.
Time Frame
12 weeks
Title
6 Minutes Pegboard and Ring Test
Description
İt measures functional capacity on the upper extremities of the body. Briefly, subjects were asked to move as many rings (each ring weighed 50 g; Zhan et al had used rings weighing half an ounce) as possible in 6 minutes, and the score was the number of rings moved during the 6-minute period. Pulse oxygen saturation was measured during the test. Scores for dyspnea were evaluated using a modified perceived exertion scale (0-10)13 immediately after the test.
Time Frame
12 weeks
Title
The Pediatric Quality of Life Inventory (PedsQ-L)test
Description
This was used to measure quality of life for children. There are subgroups measuring physically, social, sensory and the problems living at school.
Time Frame
12 weeks
Title
Muscle testing
Description
Muscle testing with the hand held dynamometer. Upper extremity muscle force will evaluate with the dynamometer.
Time Frame
12 weeks
Title
Maximal inspiratory pressure and Maximal expiratory pressure measurement
Description
Maximal inspiratory pressure and Maximal expiratory pressure will measure the respiratory muscle force with the Micro respiratory pressure measure.
Time Frame
12 weeks
Title
Glitter-Activity of Daily Living test, Activity of Daily living measurement
Description
In this test the patient reports the activities that promote discomfort during daily living activities. During its execution, functional capacity is evaluated by the time spent to perform a circuit that consists of global activities as walking, climbing up-and-down stairs, and trunk and upper limbs movements. The lower time spent the better is the functional condition. This test will measure functional capacity and easy to use.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the ages of 10-18 years Walking alone The children with chronic pulmonary diseases who can cooperate Children who can accommodate to the programme The family who gave informed consent The children who are didn't at the acute exacerbation attack. Exclusion Criteria: The children can't walk alone The children with chronic pulmonary diseases who can't cooperate The family who didn't gave informed consent The children who are at the acute exacerbation attack.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zerrin Dr Yigit, Prof
Organizational Affiliation
Istanbul University, Cardiology Institute, Cardiology Department
Official's Role
Study Director
Facility Information:
Facility Name
Gamze Baskent
City
Istanbul
ZIP/Postal Code
34272
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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The Effect of Proprioceptive Neuromuscular Facilitation (PNF) Technique for Children With Chronic Pulmonary Diseases.

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