Cystic FibrosisNCT03295201
Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
A study testing Active cycle of breathing techniques (ACBT) and Postural Exercise in people with Cystic Fibrosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Active cycle of breathing techniques (ACBT) and Postural Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2017to 24 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be diagnosed with KF
- Be able to understand commands
Who cannot join
- FEV1 below than %30
- Cor pulmonale
- Advanced gastroesophageal reflux
- Current hospital admission due to lung infection
- Be diagnosed with neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, 34899
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Active cycle of breathing techniques (ACBT), Postural Exercise
- Keywords
- Cystic Fibrosis, Postural exercise, Pulmonary rehabilitation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cycle of breathing techniques (ACBT)Other
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 ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation+exercise group | Experimental | Active cycle of breathing techniques (ACBT) and postural exercise program Receives: Other: Active cycle of breathing techniques (ACBT); Other: Postural Exercise |
| Pulmonary rehabilitation group | Active comparator | Active cycle of breathing techniques (ACBT) Receives: Other: Active cycle of breathing techniques (ACBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Measured: Before treatment
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Measured: 6 weeks
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Measured: 3 months
Pulmonary Function
Forced expiratory volume in 1 second (FEV1)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start5 Mar 2017
- Primary completion23 Oct 2017
- Study completion24 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag Saygi, MD, Prof, Study director, Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295201
- Sponsor's protocol ID
- 09.2015.287
- Status last verified
- Jan 2018
- First submitted
- 23 Aug 2017
- Last updated
- 26 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edwards J, Clarke A, Greenop D. Adults with cystic fibrosis - responding to a new ageing population. Chronic Illn. 2013 Dec;9(4):312-9. doi: 10.1177/1742395313479982. Epub 2013 May 23.
PubMed 23702786Barker N, Raghavan A, Buttling P, Douros K, Everard ML. Thoracic Kyphosis is Now Uncommon Amongst Children and Adolescents with Cystic Fibrosis. Front Pediatr. 2014 Feb 17;2:11. doi: 10.3389/fped.2014.00011. eCollection 2014.
PubMed 24596827Tattersall R, Walshaw MJ. Posture and cystic fibrosis. J R Soc Med. 2003;96 Suppl 43(Suppl 43):18-22. No abstract available.
PubMed 12906321Daniels T. Physiotherapeutic management strategies for the treatment of cystic fibrosis in adults. J Multidiscip Healthc. 2010 Nov 19;3:201-12. doi: 10.2147/JMDH.S8878.
PubMed 21289861Massery M. Musculoskeletal and neuromuscular interventions: a physical approach to cystic fibrosis. J R Soc Med. 2005;98 Suppl 45(Suppl 45):55-66.
PubMed 16025768
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03295201
- Acronym / sponsor ID
- 09.2015.287
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Postural exercise, Pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 24 Nov 2017 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 26 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation+exercise group | Experimental | Other: Active cycle of breathing techniques (ACBT), Other: Postural ExerciseActive cycle of breathing techniques (ACBT) and postural exercise program |
| Pulmonary rehabilitation group | Active comparator | Other: Active cycle of breathing techniques (ACBT)Active cycle of breathing techniques (ACBT) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Be diagnosed with KF
- Be able to understand commands
Key exclusion criteria (5 listed)
- FEV1 below than %30
- Cor pulmonale
- Advanced gastroesophageal reflux
- Current hospital admission due to lung infection
- Be diagnosed with neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Pulmonary rehabilitation group, Pulmonary rehabilitation+exercise group |
| Postural ExercisePostural 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. | Other | Pulmonary rehabilitation+exercise group |
Primary outcome
Exercise Tolerance
Time frame: 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.
Exercise Tolerance
Time frame: 6 weeks
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.
Exercise Tolerance
Time frame: 3 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.
Exercise Tolerance
Time frame: 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.
20 secondary outcomes
Quality of Life
Time frame: Before treatment
Quality of Life
Time frame: 6 weeks
Quality of Life
Time frame: 3 months
Quality of Life
Time frame: 6 months
Postural Stability
Time frame: Before treatment
Postural Stability
Time frame: 6 weeks
Postural Stability
Time frame: 3 months
Postural Stability
Time frame: 6 months
Pulmonary Function
Time frame: Before treatment
Pulmonary Function
Time frame: 6 weeks
Pulmonary Function
Time frame: 3 months
Pulmonary Function
Time frame: 6 months
Spinal Deformity- The Cobb Angle (Researcher 1)
Time frame: Before treatment
Spinal Deformity- The Cobb Angle (Researcher 2)
Time frame: Before treatment
Spinal Deformity- The Cobb Angle (Researcher 1)
Time frame: 6 months
Spinal Deformity- The Cobb Angle (Researcher 2)
Time frame: 6 months
Spinal Deformity- The Modified Cobb Angle (Researcher 1)
Time frame: Before treatment
Spinal Deformity- The Modified Cobb Angle (Researcher 2)
Time frame: Before treatment
Spinal Deformity- The Modified Cobb Angle (Researcher 1)
Time frame: 6 months
Spinal Deformity- The Modified Cobb Angle (Researcher 2)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23702786Edwards J, Clarke A, Greenop D. Adults with cystic fibrosis - responding to a new ageing population. Chronic Illn. 2013 Dec;9(4):312-9. doi: 10.1177/1742395313479982. Epub 2013 May 23.
- Background: PubMed 24596827Barker N, Raghavan A, Buttling P, Douros K, Everard ML. Thoracic Kyphosis is Now Uncommon Amongst Children and Adolescents with Cystic Fibrosis. Front Pediatr. 2014 Feb 17;2:11. doi: 10.3389/fped.2014.00011. eCollection 2014.
- Background: PubMed 12906321Tattersall R, Walshaw MJ. Posture and cystic fibrosis. J R Soc Med. 2003;96 Suppl 43(Suppl 43):18-22. No abstract available.
- Background: PubMed 21289861Daniels T. Physiotherapeutic management strategies for the treatment of cystic fibrosis in adults. J Multidiscip Healthc. 2010 Nov 19;3:201-12. doi: 10.2147/JMDH.S8878.
- Background: PubMed 16025768Massery M. Musculoskeletal and neuromuscular interventions: a physical approach to cystic fibrosis. J R Soc Med. 2005;98 Suppl 45(Suppl 45):55-66.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Karadag Saygi, MD, Prof study director
Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycle of breathing techniques (ACBT) and Postural Exercise in people with Cystic Fibrosis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Tolerance (time frame: Before treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03295201, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.