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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: Active cycle of breathing techniques (ACBT)
* Other: Postural Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be diagnosed with KF Be able to understand commands Exclusion Criteria: FEV1 below than %30 Cor pulmonale Advanced gastroesophageal reflux Current hospital admission due to lung infection Be diagnosed with neuromuscular disease

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary rehabilitation+exercise group<br>Active cycle of breathing techniques (ACBT) and postural exercise program | Other: Active cycle of breathing techniques (ACBT)<br>* 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.<br>Other: Postural Exercise<br>* 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.<br>|
| Active Comparator: Pulmonary rehabilitation group<br>Active cycle of breathing techniques (ACBT) | Other: Active cycle of breathing techniques (ACBT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Tolerance | 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. | Before treatment | 
| Exercise Tolerance | 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. | 6 weeks | 
| Exercise Tolerance | 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. | 3 months | 
| Exercise Tolerance | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | 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. | Before treatment | 
| Quality of Life | 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. | 6 weeks | 
| Quality of Life | 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. | 3 months | 
| Quality of Life | 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. | 6 months | 
| Postural Stability | 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. | Before treatment | 
| Postural Stability | 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. | 6 weeks | 
| Postural Stability | 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. | 3 months | 
| Postural Stability | 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. | 6 months | 
| Pulmonary Function | Forced expiratory volume in 1 second (FEV1) | Before treatment | 
| Pulmonary Function | Forced expiratory volume in 1 second (FEV1) | 6 weeks | 
| Pulmonary Function | Forced expiratory volume in 1 second (FEV1) | 3 months | 
| Pulmonary Function | Forced expiratory volume in 1 second (FEV1) | 6 months | 
| Spinal Deformity- The Cobb Angle (Researcher 1) | 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. | Before treatment | 
| Spinal Deformity- The Cobb Angle (Researcher 2) | 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. | Before treatment | 
| Spinal Deformity- The Cobb Angle (Researcher 1) | 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. | 6 months | 
| Spinal Deformity- The Cobb Angle (Researcher 2) | 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. | 6 months | 
| Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 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. | Before treatment | 
| Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 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. | Before treatment | 
| Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 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. | 6 months | 
| Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Postural exercise, Pulmonary rehabilitation