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

NCT ID: NCT03295201

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-05
• Study Completion Date: 2017-11-24

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pulmonary rehabilitation+exercise group

Active cycle of breathing techniques (ACBT) and postural exercise program

Group Type: EXPERIMENTAL

Active cycle of breathing techniques (ACBT)

Intervention Type: 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 Exercise

Intervention Type: OTHER

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.

Pulmonary rehabilitation group

Active cycle of breathing techniques (ACBT)

Group Type: ACTIVE_COMPARATOR

Active cycle of breathing techniques (ACBT)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evrim Karadag Saygi, MD, Prof

Role: STUDY_DIRECTOR

Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Locations

Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 23702786 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24596827 (View on PubMed)

Tattersall R, Walshaw MJ. Posture and cystic fibrosis. J R Soc Med. 2003;96 Suppl 43(Suppl 43):18-22. No abstract available.

Reference Type: BACKGROUND

PMID: 12906321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21289861 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 16025768 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

09.2015.287

Identifier Type: -

Identifier Source: org_study_id