Cystic Fibrosis Clinical Trial
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.
NCT number | NCT03420209 |
Other study ID # | 1493 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2016 |
Est. completion date | August 1, 2022 |
Verified date | February 2023 |
Source | Istanbul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Gamze Baskent | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University |
Turkey,
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. — View Citation
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 Th — View Citation
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 — View Citation
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 — View Citation
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. — View Citation
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. 201 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary function test | This test evaluates respiratory functions. Dynamic pulmonary volumes will evaluate. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 6 Minutes Walk Test | This test was used to evaluate functional capacity. They are walking during six minutes on the corridor of 30 m. If 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. | 12 weeks | |
Secondary | 6 Minutes Pegboard and Ring Test | It 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. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | Muscle testing | Muscle testing with the hand held dynamometer. Upper extremity muscle force will evaluate with the dynamometer. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |