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

Bronchiectasis Clinical Trial

Official title:

Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885521
• Other study ID #: 348/08
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2009
• Last updated: March 10, 2014
• Start date: February 2009
• Est. completion date: February 2013

Study information

• Verified date: March 2014
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• Exercise
8 week, twice weekly exercise program with endurance and upper and lower limb strength training

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria
Australia	The Alfred	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia

Sponsors (4)

Lead Sponsor	Collaborator
Bayside Health	Austin Health, Curtin University of Technology, Sir Charles Gairdner Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire		July 2011	Yes
Secondary	6-Minute Walk Test		July 2011	No