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

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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

Tracking Information
First Submitted Date  ICMJE August 23, 2017
First Posted Date  ICMJE September 27, 2017
Results First Submitted Date  ICMJE October 24, 2017
Results First Posted Date  ICMJE October 26, 2018
Last Update Posted Date October 26, 2018
Actual Study Start Date  ICMJE March 5, 2017
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
Exercise Tolerance Change [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
Modified Shuttle Test (MST)
Change History Complete list of historical versions of study NCT03295201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Pulmonary Function [ Time Frame: Before treatment ]
    Forced expiratory volume in 1 second (FEV1)
  • Pulmonary Function [ Time Frame: 6 weeks ]
    Forced expiratory volume in 1 second (FEV1)
  • Pulmonary Function [ Time Frame: 3 months ]
    Forced expiratory volume in 1 second (FEV1)
  • Pulmonary Function [ Time Frame: 6 months ]
    Forced expiratory volume in 1 second (FEV1)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
  • Quality of Life [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
    Cystic Fibrosis Questionnaire (CFQR)
  • Postural Stability [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
    The Balance Master Device- Limits of Stability Test (LOS)
  • Spinal Deformity [ Time Frame: Before treatment, 6 weeks ]
    Cobb and Modified Cobb
  • Pulmonary Function [ Time Frame: Before treatment, 6 weeks, 3 months, 6 months ]
    Forced expiratory volume in 1 second (FEV1)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
Official Title  ICMJE Clinical Effects of Exercise Program Added to Pulmonary Rehabilitation in Patients With Cystic Fibrosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Pulmonary rehabilitation+exercise group
    Active cycle of breathing techniques (ACBT) and postural exercise program
    Interventions:
    • Other: Active cycle of breathing techniques (ACBT)
    • Other: Postural Exercise
  • Active Comparator: Pulmonary rehabilitation group
    Active cycle of breathing techniques (ACBT)
    Intervention: Other: Active cycle of breathing techniques (ACBT)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2017)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 24, 2017
Actual Primary Completion Date October 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03295201
Other Study ID Numbers  ICMJE 09.2015.287
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marmara University
Study Sponsor  ICMJE Marmara University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Evrim Karadag Saygi, MD, Prof Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
PRS Account Marmara University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP