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Trial record 8 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Cystic Fibrosis"

Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT03295201
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Marmara University

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Active cycle of breathing techniques (ACBT) Other: Postural Exercise Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
Actual Study Start Date : March 5, 2017
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: Pulmonary rehabilitation+exercise group
Active cycle of breathing techniques (ACBT) and postural exercise program
Other: Active cycle of breathing techniques (ACBT)
ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.

Other: Postural Exercise
Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks.

Active Comparator: Pulmonary rehabilitation group
Active cycle of breathing techniques (ACBT)
Other: Active cycle of breathing techniques (ACBT)
ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.




Primary Outcome Measures :
  1. Exercise Tolerance Change [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
    Modified Shuttle Test (MST)


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
    Cystic Fibrosis Questionnaire (CFQR)

  2. Postural Stability [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
    The Balance Master Device- Limits of Stability Test (LOS)

  3. Spinal Deformity [ Time Frame: Before treatment, 6 weeks ]
    Cobb and Modified Cobb

  4. Pulmonary Function [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
    Forced expiratory volume in 1 second (FEV1)



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295201


Contacts
Contact: Evrim Karadag Saygi, MD, Prof 00905323612307 evrimkaradag4@hotmail.com
Contact: Kardelen Gencer Atalay, MD 00905324404887 kardelengencer@gmail.com

Locations
Turkey
Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation Recruiting
İstanbul, Turkey, 34899
Contact: Kardelen Gencer Atalay, MD    00905324404887    kardelengencer@gmail.com   
Sponsors and Collaborators
Marmara University
Investigators
Study Director: Evrim Karadag Saygi, MD, Prof Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Publications:
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03295201     History of Changes
Other Study ID Numbers: 09.2015.287
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marmara University:
Cystic Fibrosis
Postural exercise
Pulmonary rehabilitation

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases