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Chronic Respiratory DiseaseNCT03420209

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

A study testing Group applying PNF technique in people with Chronic Respiratory Disease and Cystic Fibrosis, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 18 years
What is being tested?
Group applying PNF technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2016to 1 Aug 2022
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 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gamze Baskent

    Istanbul, 34272

Other trials in Turkey (Türkiye)

About this study

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.

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.

Read the 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.

Being tested
Group applying PNF technique
Keywords
proprioceptive neuromuscular facilitation, respiratory functions, elastic band, posture
Medical subject headings
Cystic Fibrosis, Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group applying PNF techniqueBehavioural

Study groups in NCT03420209
Study groupRoleWhat they receive
Group applying PNF techniqueExperimentalThe 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.
Receives: Behavioral: Group applying PNF technique
Home ProgrammeNo interventionThis group will perform only breathing exercises daily at home during 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary function test

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

    Measured: 12 weeks

Secondary outcomes (7)
  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. Muscle testing

    Muscle testing with the hand held dynamometer. Upper extremity muscle force will evaluate with the dynamometer.

    Measured: 12 weeks

  6. 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.

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start1 Dec 2016
  3. Primary completion1 Aug 2022
  4. Study completion1 Aug 2022

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03420209
Sponsor's protocol ID
1493
Status last verified
Feb 2023
First submitted
27 Jan 2018
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mays RJ, Goss FL, Nagle EF, Gallagher M Jr, Haile L, Schafer MA, Kim KH, Robertson RJ. Cross-validation of Peak Oxygen Consumption Prediction Models From OMNI Perceived Exertion. Int J Sports Med. 2016 Sep;37(10):831-7. doi: 10.1055/s-0042-103029. Epub 2016 Jul 13.

    PubMed 27410768
  • Bass JL, Corwin M, Gozal D, Moore C, Nishida H, Parker S, Schonwald A, Wilker RE, Stehle S, Kinane TB. The effect of chronic or intermittent hypoxia on cognition in childhood: a review of the evidence. Pediatrics. 2004 Sep;114(3):805-16. doi: 10.1542/peds.2004-0227.

    PubMed 15342857
  • Kamel TB, Abd Elmonaem MT, Khalil LH, Goda MH, Sanyelbhaa H, Ramzy MA. Children with chronic lung diseases have cognitive dysfunction as assessed by event-related potential (auditory P300) and Stanford-Binet IQ (SB-IV) test. Eur Arch Otorhinolaryngol. 2016 Oct;273(10):3413-20. doi: 10.1007/s00405-016-4044-z. Epub 2016 Apr 13.

    PubMed 27075686
  • Rossi UG, Owens CM. The radiology of chronic lung disease in children. Arch Dis Child. 2005 Jun;90(6):601-7. doi: 10.1136/adc.2004.051383.

    PubMed 15908625
  • Arikan H, Yatar I, Calik-Kutukcu E, Aribas Z, Saglam M, Vardar-Yagli N, Savci S, Inal-Ince D, Ozcelik U, Kiper N. A comparison of respiratory and peripheral muscle strength, functional exercise capacity, activities of daily living and physical fitness in patients with cystic fibrosis and healthy subjects. Res Dev Disabil. 2015 Oct-Nov;45-46:147-56. doi: 10.1016/j.ridd.2015.07.020. Epub 2015 Aug 1.

    PubMed 26241869
  • Santana-Sosa E, Gonzalez-Saiz L, Groeneveld IF, Villa-Asensi JR, Barrio Gomez de Aguero MI, Fleck SJ, Lopez-Mojares LM, Perez M, Lucia A. Benefits of combining inspiratory muscle with 'whole muscle' training in children with cystic fibrosis: a randomised controlled trial. Br J Sports Med. 2014 Oct;48(20):1513-7. doi: 10.1136/bjsports-2012-091892. Epub 2013 May 16.

    PubMed 23681502
  • Alison JA, Regnis JA, Donnelly PM, Adams RD, Sutton JR, Bye PT. Evaluation of supported upper limb exercise capacity in patients with cystic fibrosis. Am J Respir Crit Care Med. 1997 Nov;156(5):1541-8. doi: 10.1164/ajrccm.156.5.97-02034.

    PubMed 9372673
  • Wells GD, Wilkes DL, Schneiderman JE, Thompson S, Coates AL, Ratjen F. Physiological correlates of pulmonary function in children with cystic fibrosis. Pediatr Pulmonol. 2014 Sep;49(9):878-84. doi: 10.1002/ppul.22928. Epub 2013 Oct 25.

    PubMed 24166871
  • Sharman MJ, Cresswell AG, Riek S. Proprioceptive neuromuscular facilitation stretching : mechanisms and clinical implications. Sports Med. 2006;36(11):929-39. doi: 10.2165/00007256-200636110-00002.

    PubMed 17052131
  • Williams JG, Odley JL, Callaghan M. Motor Imagery Boosts Proprioceptive Neuromuscular Facilitation in the Attainment and Retention of Range-of -Motion at the Hip Joint. J Sports Sci Med. 2004 Sep 1;3(3):160-6. eCollection 2004 Sep.

    PubMed 24482593
  • Porto EF, Castro AA, Nascimento O, Oliveira RC, Cardoso F, Jardim JR. Modulation of operational lung volumes with the use of salbutamol in COPD patients accomplishing upper limbs exercise tests. Respir Med. 2009 Feb;103(2):251-7. doi: 10.1016/j.rmed.2008.08.018. Epub 2008 Oct 19.

    PubMed 18930646
  • Seo K, Cho M. The effects on the pulmonary function of normal adults proprioceptive neuromuscular facilitation respiration pattern exercise. J Phys Ther Sci. 2014 Oct;26(10):1579-82. doi: 10.1589/jpts.26.1579. Epub 2014 Oct 28.

    PubMed 25364117
  • Areas GP, Borghi-Silva A, Lobato AN, Silva AA, Freire RC Jr, Areas FZ. Effect of upper extremity proprioceptive neuromuscular facilitation combined with elastic resistance bands on respiratory muscle strength: a randomized controlled trial. Braz J Phys Ther. 2013 Nov-Dec;17(6):541-6. doi: 10.1590/S1413-35552012005000131. Epub 2013 Nov 1.

    PubMed 24346292
  • Colado JC, Pedrosa FM, Juesas A, Gargallo P, Carrasco JJ, Flandez J, Chupel MU, Teixeira AM, Naclerio F. Concurrent validation of the OMNI-Resistance Exercise Scale of perceived exertion with elastic bands in the elderly. Exp Gerontol. 2018 Mar;103:11-16. doi: 10.1016/j.exger.2017.12.009. Epub 2017 Dec 17.

    PubMed 29262307

Questions about this trial

What is this clinical trial studying?

A study testing Group applying PNF technique in people with Chronic Respiratory Disease and Cystic Fibrosis, run by Istanbul University 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 1 Mar 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary function test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03420209, which also lists 14 linked publications.

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 1 Mar 2023.

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