NCT00885521

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. 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. 2.Exercise training will significantly reduce the incidence of pulmonary exacerbations, use of antibiotics and rate of hospitalisation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

4 years

First QC Date

April 21, 2009

Last Update Submit

March 10, 2014

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire

    July 2011

Secondary Outcomes (1)

  • 6-Minute Walk Test

    July 2011

Study Arms (2)

Exercise

EXPERIMENTAL

8 week, twice weekly exercise program with both endurance and upper and lower limb strength training

Other: Exercise

2

NO INTERVENTION

No exercise, twice weekly phone calls

Interventions

ExerciseOTHER

8 week, twice weekly exercise program with endurance and upper and lower limb strength training

Exercise

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Alfred

Melbourne, Victoria, 3004, Australia

Location

Austin Health

Melbourne, Victoria, Australia

Location

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Location

Related Publications (3)

  • 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.

    PMID: 26252343DERIVED

  • 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.

    PMID: 24731015DERIVED

  • 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.

    PMID: 20122281DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Annemarie L Lee, PhD

    Bayside Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 11, 2014

Record last verified: 2014-03

Locations

AU(3)