Clinical trial NCT03420209: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Disease
Cystic Fibrosis
Bronchiectasis
Keywords: proprioceptive neuromuscular facilitation
respiratory functions
elastic band
posture
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary function test
timeFrame: 12 weeks
Secondary outcomes:
measure: Posture Analysis
timeFrame: 12 weeks
measure: 6 Minutes Walk Test
timeFrame: 12 weeks
measure: 6 Minutes Pegboard and Ring Test
timeFrame: 12 weeks
measure: The Pediatric Quality of Life Inventory (PedsQ-L)test
timeFrame: 12 weeks
measure: Muscle testing
timeFrame: 12 weeks
measure: Maximal inspiratory pressure and Maximal expiratory pressure measurement
timeFrame: 12 weeks
measure: Glitter-Activity of Daily Living test, Activity of Daily living measurement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gamze Baskent
Study officials:
affiliation: Istanbul University, Cardiology Institute, Cardiology Department
name: Zerrin Dr Yigit, Prof
role: STUDY_DIRECTOR
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