Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis

• ClinicalTrials.gov Identifier: NCT00885521
• Recruitment Status: Completed
• First Posted: April 22, 2009
• Last Update Posted: March 11, 2014
• Sponsor: Bayside Health
• Collaborators: Austin Health; Sir Charles Gairdner Hospital; Curtin University
• Information provided by (Responsible Party): Bayside Health

Study Description

Brief Summary:

The aim of this project is to examine the short and long term effects of an 8 week, twice weekly, outpatient exercise training program for people with bronchiectasis. Participants will be randomly allocated to undergo a supervised exercise training program at The Alfred, Austin Hospital or Sir Charles Gairdner Hospital.

The hypotheses of this study are:

1. Patients with bronchiectasis who complete an exercise program will have a higher exercise capacity and better quality of life and these improvements will be sustained for up to 12 months after completion
2. Exercise training will significantly reduce the incidence of pulmonary exacerbations, use of antibiotics and rate of hospitalisation

Condition or disease	Intervention/treatment	Phase
Bronchiectasis	Other: Exercise	Phase 1

Detailed Description:

Bronchiectasis not related to cystic fibrosis (non-CF bronchiectasis) is a chronic respiratory condition characterised by permanent dilatation of the airways arising from bronchial inflammation and infection. Predominant symptoms include daily productive cough, dyspnoea and generalised fatigue. This profile is associated with diminished health-related quality of life (HRQOL) and reduced exercise tolerance.

Available medical treatments for bronchiectasis include antibiotic and inhalation therapy. To date, there is no evidence that these treatments can reduce the exacerbation rate or modify the rate of disease progression. While international guidelines for pulmonary rehabilitation recommend the inclusion of patients with bronchiectasis, there is a deficiency in evidence supporting exercise training in this population. It is proposed that a standard exercise training program conducted according to Australian guidelines for pulmonary rehabilitation will improve both exercise capacity, quality of life and reduce the number of acute infections in both the short and long term in people with bronchiectasis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial
• Study Start Date: February 2009
• Actual Primary Completion Date: February 2013
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise; 8 week, twice weekly exercise program with both endurance and upper and lower limb strength training	Other: Exercise; 8 week, twice weekly exercise program with endurance and upper and lower limb strength training
No Intervention: 2; No exercise, twice weekly phone calls

Outcome Measures

Primary Outcome Measures :

1. Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire [ Time Frame: July 2011 ]

Secondary Outcome Measures :

1. 6-Minute Walk Test [ Time Frame: July 2011 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Diagnosis of bronchiectasis (HRCT)
• Stable medical status for last 4 weeks
• History of 2 exacerbations in the last 2 years
• Dysnpoea on exertion (Modified Medical Research Council score >1)

Exclusion Criteria:

• Concurrent diagnosis of COPD (physician diagnosis and history of 10 pack year smoking)
• Concurrent diagnosis of asthma (history of atopic disease and evidence of bronchodilator reversibility of 12% or 200ml in FEV1 or FVC)
• Concurrent diagnosis of Interstitial lung disease
• Concurrent diagnosis of Cystic Fibrosis
• Medical condition which could place patient at risk during exercise training (angina, neurological or orthopaedic condition)
• Prior completion of pulmonary rehabilitation within the last 12 months

Contacts and Locations

Locations

Australia, Victoria

The Alfred

Melbourne, Victoria, Australia, 3004

Austin Health

Melbourne, Victoria, Australia

Australia, Western Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Sponsors and Collaborators

Bayside Health

Austin Health

Sir Charles Gairdner Hospital

Curtin University

Investigators

• Principal Investigator: Annemarie L Lee, PhD; Bayside Health

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lee AL, Cecins N, Holland AE, Hill CJ, McDonald CF, Burge AT, Rautela L, Thompson PJ, Stirling RG, Jenkins S. Field Walking Tests Are Reliable and Responsive to Exercise Training in People With Non-Cystic Fibrosis Bronchiectasis. J Cardiopulm Rehabil Prev. 2015 Nov-Dec;35(6):439-45. doi: 10.1097/HCR.0000000000000130.

Lee AL, Hill CJ, Cecins N, Jenkins S, McDonald CF, Burge AT, Rautela L, Stirling RG, Thompson PJ, Holland AE. The short and long term effects of exercise training in non-cystic fibrosis bronchiectasis--a randomised controlled trial. Respir Res. 2014 Apr 15;15(1):44. doi: 10.1186/1465-9921-15-44.

Lee AL, Cecins N, Hill CJ, Holland AE, Rautela L, Stirling RG, Thompson PJ, McDonald CF, Jenkins S. The effects of pulmonary rehabilitation in patients with non-cystic fibrosis bronchiectasis: protocol for a randomised controlled trial. BMC Pulm Med. 2010 Feb 2;10:5. doi: 10.1186/1471-2466-10-5.

• Responsible Party: Bayside Health
• ClinicalTrials.gov Identifier: NCT00885521
• Other Study ID Numbers: 348/08
• First Posted: April 22, 2009
• Last Update Posted: March 11, 2014
• Last Verified: March 2014

Additional relevant MeSH terms:

Bronchiectasis; Bronchial Diseases; Respiratory Tract Diseases