Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Postural exercise, Pulmonary rehabilitation
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.
Interventions
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.
OTHERPostural 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.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Tolerance | Before treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Postural Stability | Before treatment | 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 | Before treatment | Forced expiratory volume in 1 second (FEV1) |
| Spinal Deformity- The Cobb Angle (Researcher 1) | Before treatment | 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. |
| Quality of Life | Before treatment | 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 Modified Cobb Angle (Researcher 1) | Before treatment | 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) | Before treatment | 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 Cobb Angle (Researcher 2) | Before treatment | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Recruitment period was March 2017-October 2017 Setting: A university hospital outpatient clinics
Pre-assignment details
Number of patients assessed for eligibility was 30. Among them,8 participants were excluded due to being inappropiate for the inclusion criteria (6 were out of age limits, 2 did not agree to participate in the study)
Participants by arm
| Arm | Count |
|---|---|
| Pulmonary Rehabilitation+Exercise Group Active cycle of breathing techniques (ACBT) and postural exercise program
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.
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. | 10 |
| Pulmonary Rehabilitation Group Active cycle of breathing techniques (ACBT)
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. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Hospital admission | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group | Total |
|---|---|---|---|
| Age, Continuous | 9 years STANDARD_DEVIATION 2 | 10 years STANDARD_DEVIATION 3 | 9 years STANDARD_DEVIATION 2 |
| Body Mass Index | 16 kg/m^2 STANDARD_DEVIATION 2 | 16 kg/m^2 STANDARD_DEVIATION 2 | 16 kg/m^2 STANDARD_DEVIATION 2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 10 participants | 9 participants | 19 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
Primary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Exercise Tolerance | 1251 meters | Standard Error 324.15 |
| Pulmonary Rehabilitation Group | Exercise Tolerance | 1161.11 meters | Standard Error 594.06 |
Primary
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.
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Exercise Tolerance | 817 meters | Standard Error 234.62 |
| Pulmonary Rehabilitation Group | Exercise Tolerance | 792.22 meters | Standard Error 327.21 |
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Exercise Tolerance | 980 meters | Standard Error 277.24 |
| Pulmonary Rehabilitation Group | Exercise Tolerance | 1058.77 meters | Standard Error 594.67 |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Exercise Tolerance | 1104 meters | Standard Error 306.73 |
| Pulmonary Rehabilitation Group | Exercise Tolerance | 1036.66 meters | Standard Error 457.16 |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Postural Stability | 0.91 seconds | Standard Error 0.66 |
| Pulmonary Rehabilitation Group | Postural Stability | 0.83 seconds | Standard Error 0.65 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Postural Stability | 1.15 seconds | Standard Error 0.69 |
| Pulmonary Rehabilitation Group | Postural Stability | 0.92 seconds | Standard Error 0.46 |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Postural Stability | 0.88 seconds | Standard Error 0.72 |
| Pulmonary Rehabilitation Group | Postural Stability | 0.65 seconds | Standard Error 0.52 |
Secondary
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.
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Postural Stability | 1.29 seconds | Standard Error 0.85 |
| Pulmonary Rehabilitation Group | Postural Stability | 1.03 seconds | Standard Error 0.53 |
Secondary
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Pulmonary Function | 87.7 millilitres | Standard Deviation 16.95 |
| Pulmonary Rehabilitation Group | Pulmonary Function | 90 millilitres | Standard Deviation 23.52 |
Secondary
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Pulmonary Function | 82.8 millilitres | Standard Deviation 14.57 |
| Pulmonary Rehabilitation Group | Pulmonary Function | 83.78 millilitres | Standard Deviation 21.06 |
Secondary
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Pulmonary Function | 93.3 millilitres | Standard Deviation 21.71 |
| Pulmonary Rehabilitation Group | Pulmonary Function | 82.11 millilitres | Standard Deviation 17.14 |
Secondary
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Pulmonary Function | 86.6 millilitres | Standard Deviation 12.19 |
| Pulmonary Rehabilitation Group | Pulmonary Function | 82.77 millilitres | Standard Deviation 17.85 |
Secondary
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.
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Quality of Life | 86.4 units on a scale | Standard Error 5.75 |
| Pulmonary Rehabilitation Group | Quality of Life | 92.77 units on a scale | Standard Error 9.94 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Quality of Life | 89.7 units on a scale | Standard Error 7.84 |
| Pulmonary Rehabilitation Group | Quality of Life | 95.55 units on a scale | Standard Error 12.64 |
Secondary
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Quality of Life | 87.2 units on a scale | Standard Error 5.57 |
| Pulmonary Rehabilitation Group | Quality of Life | 93.33 units on a scale | Standard Error 11.35 |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Quality of Life | 88.9 units on a scale | Standard Error 7.04 |
| Pulmonary Rehabilitation Group | Quality of Life | 90.88 units on a scale | Standard Error 13.37 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Cobb Angle (Researcher 1) | 3.5 degrees | Standard Deviation 2.56 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Cobb Angle (Researcher 1) | 5.25 degrees | Standard Deviation 3.41 |
Secondary
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.
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Cobb Angle (Researcher 1) | 2.37 degrees | Standard Deviation 1.4 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Cobb Angle (Researcher 1) | 7.75 degrees | Standard Deviation 5.95 |
Secondary
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.
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Cobb Angle (Researcher 2) | 2.12 degrees | Standard Deviation 2.1 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Cobb Angle (Researcher 2) | 7.75 degrees | Standard Deviation 5.12 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Cobb Angle (Researcher 2) | 3.88 degrees | Standard Deviation 2.42 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Cobb Angle (Researcher 2) | 5.5 degrees | Standard Deviation 2.83 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 35.5 degrees | Standard Deviation 8.09 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 32.33 degrees | Standard Deviation 3.08 |
Secondary
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.
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 35.33 degrees | Standard Deviation 12.62 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 34.33 degrees | Standard Deviation 6.84 |
Secondary
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.
Time frame: Before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 34.67 degrees | Standard Deviation 11.76 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 33.11 degrees | Standard Deviation 7.4 |
Secondary
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 35 degrees | Standard Deviation 7.87 |
| Pulmonary Rehabilitation Group | Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 32.4 degrees | Standard Deviation 3.33 |