An interventional study of Active cycle of breathing techniques (ACBT) and Postural Exercise in Cystic Fibrosis, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Active cycle of breathing techniques (ACBT) and postural exercise program
Other: Active cycle of breathing techniques (ACBT) · Other: Postural Exercise
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: Before treatment
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: 6 weeks
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: 3 months
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Recruitment period was March 2017-October 2017 Setting: A university hospital outpatient clinics
| Milestone | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Started | 11 | 11 |
| Completed | 10 | 9 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Hospital admission | 0 | 1 |
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.
| meters | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Exercise Tolerance | 817 ± 234.62 | 792.22 ± 327.21 |
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.
| meters | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Exercise Tolerance | 980 ± 277.24 | 1058.77 ± 594.67 |
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.
| meters | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Exercise Tolerance | 1104 ± 306.73 | 1036.66 ± 457.16 |
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.
| meters | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Exercise Tolerance | 1251 ± 324.15 | 1161.11 ± 594.06 |
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.
| units on a scale | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Quality of Life | 86.4 ± 5.75 | 92.77 ± 9.94 |
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.
| units on a scale | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Quality of Life | 88.9 ± 7.04 | 90.88 ± 13.37 |
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.
| units on a scale | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Quality of Life | 87.2 ± 5.57 | 93.33 ± 11.35 |
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.
| units on a scale | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Quality of Life | 89.7 ± 7.84 | 95.55 ± 12.64 |
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.
| seconds | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Postural Stability | 1.29 ± 0.85 | 1.03 ± 0.53 |
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.
| seconds | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Postural Stability | 0.91 ± 0.66 | 0.83 ± 0.65 |
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.
| seconds | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Postural Stability | 0.88 ± 0.72 | 0.65 ± 0.52 |
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.
| seconds | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Postural Stability | 1.15 ± 0.69 | 0.92 ± 0.46 |
Forced expiratory volume in 1 second (FEV1)
| millilitres | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Pulmonary Function | 82.8 ± 14.57 | 83.78 ± 21.06 |
Forced expiratory volume in 1 second (FEV1)
| millilitres | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Pulmonary Function | 93.3 ± 21.71 | 82.11 ± 17.14 |
Forced expiratory volume in 1 second (FEV1)
| millilitres | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Pulmonary Function | 86.6 ± 12.19 | 82.77 ± 17.85 |
Forced expiratory volume in 1 second (FEV1)
| millilitres | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Pulmonary Function | 87.7 ± 16.95 | 90 ± 23.52 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Cobb Angle (Researcher 1) | 2.37 ± 1.40 | 7.75 ± 5.95 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Cobb Angle (Researcher 2) | 2.12 ± 2.1 | 7.75 ± 5.12 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Cobb Angle (Researcher 1) | 3.5 ± 2.56 | 5.25 ± 3.41 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Cobb Angle (Researcher 2) | 3.88 ± 2.42 | 5.5 ± 2.83 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 35.33 ± 12.62 | 34.33 ± 6.84 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 34.67 ± 11.76 | 33.11 ± 7.4 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Modified Cobb Angle (Researcher 1) | 35.5 ± 8.09 | 32.33 ± 3.08 |
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.
| degrees | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group |
|---|---|---|
| Spinal Deformity- The Modified Cobb Angle (Researcher 2) | 35 ± 7.87 | 32.4 ± 3.33 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pulmonary Rehabilitation+Exercise Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Pulmonary Rehabilitation Group | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group | Total |
|---|---|---|---|
| Mean | 9 ± 2 | 10 ± 3 | 9 ± 2 |
| Sex: Female, Male(Participants) | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 7 | 5 | 12 |
| Race and Ethnicity Not Collected(Participants) | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group | Total |
|---|---|---|---|
| Turkey | 10 | 9 | 19 |
| Body Mass Index(kg/m^2) | Pulmonary Rehabilitation+Exercise Group | Pulmonary Rehabilitation Group | Total |
|---|---|---|---|
| Mean | 16 ± 2 | 16 ± 2 | 16 ± 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Marmara University