Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis
Eligibility 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
Sites / Locations
- The Alfred
- Austin Health
- Sir Charles Gairdner Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
2
Arm Description
8 week, twice weekly exercise program with both endurance and upper and lower limb strength training
No exercise, twice weekly phone calls
Outcomes
Primary Outcome Measures
Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire
Secondary Outcome Measures
6-Minute Walk Test
Full Information
NCT ID
NCT00885521
First Posted
April 21, 2009
Last Updated
March 10, 2014
Sponsor
Bayside Health
Collaborators
Austin Health, Sir Charles Gairdner Hospital, Curtin University
1. Study Identification
Unique Protocol Identification Number
NCT00885521
Brief Title
Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis
Official Title
Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
Austin Health, Sir Charles Gairdner Hospital, Curtin University
4. Oversight
Data Monitoring Committee
Yes
5. 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:
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
Exercise training will significantly reduce the incidence of pulmonary exacerbations, use of antibiotics and rate of hospitalisation
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
8 week, twice weekly exercise program with both endurance and upper and lower limb strength training
Arm Title
2
Arm Type
No Intervention
Arm Description
No exercise, twice weekly phone calls
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
8 week, twice weekly exercise program with endurance and upper and lower limb strength training
Primary Outcome Measure Information:
Title
Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire
Time Frame
July 2011
Secondary Outcome Measure Information:
Title
6-Minute Walk Test
Time Frame
July 2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annemarie L Lee, PhD
Organizational Affiliation
Bayside Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
26252343
Citation
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.
Results Reference
derived
PubMed Identifier
24731015
Citation
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.
Results Reference
derived
PubMed Identifier
20122281
Citation
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.
Results Reference
derived
Learn more about this trial
Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis
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