ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03295201
Recruitment Status : Completed
First Posted : September 27, 2017
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Active cycle of breathing techniques (ACBT) Other: Postural Exercise Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
Actual Study Start Date : March 5, 2017
Actual Primary Completion Date : October 23, 2017
Actual Study Completion Date : November 24, 2017


Arm Intervention/treatment
Experimental: Pulmonary rehabilitation+exercise group
Active cycle of breathing techniques (ACBT) and postural exercise program
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.

Other: 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.

Active Comparator: Pulmonary rehabilitation group
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 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.

  2. Quality of Life [ Time Frame: 6 weeks ]
    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. Quality of Life [ Time Frame: 3 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.

  4. Quality of Life [ Time Frame: 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.

  5. Postural Stability [ Time Frame: 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.

  6. Postural Stability [ Time Frame: 6 weeks ]
    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.

  7. Postural Stability [ Time Frame: 3 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.

  8. Postural Stability [ Time Frame: 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.

  9. Pulmonary Function [ Time Frame: Before treatment ]
    Forced expiratory volume in 1 second (FEV1)

  10. Pulmonary Function [ Time Frame: 6 weeks ]
    Forced expiratory volume in 1 second (FEV1)

  11. Pulmonary Function [ Time Frame: 3 months ]
    Forced expiratory volume in 1 second (FEV1)

  12. Pulmonary Function [ Time Frame: 6 months ]
    Forced expiratory volume in 1 second (FEV1)

  13. Spinal Deformity- The Cobb Angle (Researcher 1) [ Time Frame: 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.

  14. Spinal Deformity- The Cobb Angle (Researcher 2) [ Time Frame: 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.

  15. Spinal Deformity- The Cobb Angle (Researcher 1) [ Time Frame: 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.

  16. Spinal Deformity- The Cobb Angle (Researcher 2) [ Time Frame: 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.

  17. Spinal Deformity- The Modified Cobb Angle (Researcher 1) [ Time Frame: 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.

  18. Spinal Deformity- The Modified Cobb Angle (Researcher 2) [ Time Frame: 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.

  19. Spinal Deformity- The Modified Cobb Angle (Researcher 1) [ Time Frame: 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.

  20. Spinal Deformity- The Modified Cobb Angle (Researcher 2) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295201


Locations
Turkey
Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
İstanbul, Turkey, 34899
Sponsors and Collaborators
Marmara University
Investigators
Study Director: Evrim Karadag Saygi, MD, Prof Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
  Study Documents (Full-Text)

Documents provided by Marmara University:

Publications:
Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03295201     History of Changes
Other Study ID Numbers: 09.2015.287
First Posted: September 27, 2017    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marmara University:
Cystic Fibrosis
Postural exercise
Pulmonary rehabilitation

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases