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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Active cycle of breathing techniques (ACBT); Other: Postural Exercise

• Registration Number: NCT03295201
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-03-05
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Primary Completion: 2017-10-23
• Results First Submitted: 2017-10-24
• Study Completion: 2017-11-24
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Results First Posted: 2018-10-26
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary rehabilitation+exercise group	Postural Exercise	Active cycle of breathing techniques (ACBT) and postural exercise program
Pulmonary rehabilitation group	Active cycle of breathing techniques (ACBT)	Active cycle of breathing techniques (ACBT)
Pulmonary rehabilitation+exercise group	Active cycle of breathing techniques (ACBT)	Active cycle of breathing techniques (ACBT) and postural exercise program

Primary Outcome Measures

Name	Time	Method
Exercise Tolerance	6 months	Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.

Secondary Outcome Measures

Name	Time	Method
Postural Stability	6 months	The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time (seconds) parameter is preferred to use for this study.
Pulmonary Function	6 months	Forced expiratory volume in 1 second (FEV1)
Spinal Deformity- The Cobb Angle (Researcher 1)	6 months	The Cobb angle was measured on anteroposterior scoliosis graphs by the angle between the superior end plate of the vertebra corpus where the curve begins and the end plate of the vertebra corpus which the curve ends.
Spinal Deformity- The Modified Cobb Angle (Researcher 1)	6 months	The Modified Cobb angle was found on lateral scoliosis graphs by the angle between the superior end plate of the T4 vertebra corpus and the inferior end plate of the T12 vertebra corpus.
Spinal Deformity- The Modified Cobb Angle (Researcher 2)	6 months	The Modified Cobb angle was found on lateral scoliosis graphs by the angle between the superior end plate of the T4 vertebra corpus and the inferior end plate of the T12 vertebra corpus.
Quality of Life	6 months	The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.
Spinal Deformity- The Cobb Angle (Researcher 2)	6 months	The Cobb angle was measured on anteroposterior scoliosis graphs by the angle between the superior end plate of the vertebra corpus where the curve begins and the end plate of the vertebra corpus which the curve ends.

Trial Locations

Locations (1)

Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation; 🇹🇷 İstanbul, Turkey