Clinical trial NCT03295201: Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
Official title: Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Postural exercise
Pulmonary rehabilitation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with Cystic Fibrosis.

Detailed description: Cystic fibrosis (CF) is an autosomal recessive, multisystem involvement disease. The most important cause of mortality in CF is pulmonary complications. Prevention of pulmonary complications is only possible with pulmonary rehabilitation. Pulmonary rehabilitation methods used in CF are called airway cleaning techniques that include postural drainage, breathing techniques and use of devices. These techniques have not been proven to be superior to each other. Active cycle of breathing techniques (ACBT) is one of the breathing techniques used to remove secretions from the lungs.

Pulmonary disease progression in CF causes postural impairment and decrease of exercise tolerance, which can reduce effectiveness of pulmonary rehabilitation. The aim of this study is to investigate the effects of postural exercise program added to pulmonary rehabilitation program on quality of life, exercise tolerance and postural stability in children with CF.

Eligibility criteria: Inclusion Criteria:

1. Be diagnosed with KF
2. Be able to understand commands

Exclusion Criteria:

1. FEV1 below than %30
2. Cor pulmonale
3. Advanced gastroesophageal reflux
4. Current hospital admission due to lung infection
5. Be diagnosed with neuromuscular disease

Primary outcomes:
measure: Exercise Tolerance
timeFrame: Before treatment
measure: Exercise Tolerance
timeFrame: 6 weeks
measure: Exercise Tolerance
timeFrame: 3 months
measure: Exercise Tolerance
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life
timeFrame: Before treatment
measure: Quality of Life
timeFrame: 6 weeks
measure: Quality of Life
timeFrame: 3 months
measure: Quality of Life
timeFrame: 6 months
measure: Postural Stability
timeFrame: Before treatment
measure: Postural Stability
timeFrame: 6 weeks
measure: Postural Stability
timeFrame: 3 months
measure: Postural Stability
timeFrame: 6 months
measure: Pulmonary Function
timeFrame: Before treatment
measure: Pulmonary Function
timeFrame: 6 weeks
measure: Pulmonary Function
timeFrame: 3 months
measure: Pulmonary Function
timeFrame: 6 months
measure: Spinal Deformity- The Cobb Angle (Researcher 1)
timeFrame: Before treatment
measure: Spinal Deformity- The Cobb Angle (Researcher 2)
timeFrame: Before treatment
measure: Spinal Deformity- The Cobb Angle (Researcher 1)
timeFrame: 6 months
measure: Spinal Deformity- The Cobb Angle (Researcher 2)
timeFrame: 6 months
measure: Spinal Deformity- The Modified Cobb Angle (Researcher 1)
timeFrame: Before treatment
measure: Spinal Deformity- The Modified Cobb Angle (Researcher 2)
timeFrame: Before treatment
measure: Spinal Deformity- The Modified Cobb Angle (Researcher 1)
timeFrame: 6 months
measure: Spinal Deformity- The Modified Cobb Angle (Researcher 2)
timeFrame: 6 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
name: Evrim Karadag Saygi, MD, Prof
role: STUDY_DIRECTOR
References:
citation: Edwards J, Clarke A, Greenop D. Adults with cystic fibrosis - responding to a new ageing population. Chronic Illn. 2013 Dec;9(4):312-9. doi: 10.1177/1742395313479982. Epub 2013 May 23.
citation: Barker N, Raghavan A, Buttling P, Douros K, Everard ML. Thoracic Kyphosis is Now Uncommon Amongst Children and Adolescents with Cystic Fibrosis. Front Pediatr. 2014 Feb 17;2:11. doi: 10.3389/fped.2014.00011. eCollection 2014.
citation: Tattersall R, Walshaw MJ. Posture and cystic fibrosis. J R Soc Med. 2003;96 Suppl 43(Suppl 43):18-22. No abstract available.
citation: Daniels T. Physiotherapeutic management strategies for the treatment of cystic fibrosis in adults. J Multidiscip Healthc. 2010 Nov 19;3:201-12. doi: 10.2147/JMDH.S8878.
citation: Massery M. Musculoskeletal and neuromuscular interventions: a physical approach to cystic fibrosis. J R Soc Med. 2005;98 Suppl 45(Suppl 45):55-66.