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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295201
• Other study ID #: 09.2015.287
• Status: Completed
• Phase: N/A
• Start date: March 5, 2017
• Est. completion date: November 24, 2017

Study information

• Verified date: January 2018
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 24, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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
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.

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Barker 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. — View Citation

Daniels 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. — View Citation

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. — View Citation

Massery M. Musculoskeletal and neuromuscular interventions: a physical approach to cystic fibrosis. J R Soc Med. 2005;98 Suppl 45:55-66. Review. — View Citation

Tattersall R, Walshaw MJ. Posture and cystic fibrosis. J R Soc Med. 2003;96 Suppl 43:18-22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Before treatment
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.	6 weeks
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.	3 months
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.	6 months
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.	Before treatment
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.	6 weeks
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.	3 months
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.	6 months
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.	Before treatment
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.	6 weeks
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.	3 months
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.	6 months
Secondary	Pulmonary Function	Forced expiratory volume in 1 second (FEV1)	Before treatment
Secondary	Pulmonary Function	Forced expiratory volume in 1 second (FEV1)	6 weeks
Secondary	Pulmonary Function	Forced expiratory volume in 1 second (FEV1)	3 months
Secondary	Pulmonary Function	Forced expiratory volume in 1 second (FEV1)	6 months
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.	Before treatment
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.	Before treatment
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.	6 months
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.	6 months
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.	Before treatment
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.	Before treatment
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.	6 months
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.	6 months