NCT01423227

Brief Summary

Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program. We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months. If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

August 11, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 25, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3.6 years

First QC Date

August 11, 2011

Last Update Submit

August 12, 2019

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDexerciserehabilitationdyspneaquality of lifeeconomic evaluation

Outcome Measures

Primary Outcomes (1)

  • Change in 6-minute walk test

    Testing equivalence between groups

    Baseline, 8 weeks and 12 months

Secondary Outcomes (5)

  • Change in Chronic Respiratory Disease Questionnaire

    Baseline, 8 weeks and 12 months

  • Change in Modified Medical Research Council Scale

    Baseline, 8 weeks and 12 months

  • Cost-effectiveness

    12 months

  • SF-36 v2

    Baseline, 8 weeks and 12 months

  • Program completion rate

    8 weeks

Study Arms (2)

Home-based pulmonary rehabilitation

EXPERIMENTAL

Home visit plus 8 weeks of once-weekly telephone calls

Behavioral: Home-based pulmonary rehabilitation

Hospital-based pulmonary rehabilitation

ACTIVE COMPARATOR

Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Behavioral: Hospital-based pulmonary rehabilitation

Interventions

Home-based pulmonary rehabilitationBEHAVIORAL

One home visit plus weekly telephone calls for 8 weeks

Home-based pulmonary rehabilitation
Hospital-based pulmonary rehabilitationBEHAVIORAL

Standard twice-weekly 8-week outpatient pulmonary rehabilitation program

Hospital-based pulmonary rehabilitation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current or former smokers of at least 10 packet years
  • aged 40 years or over
  • diagnosis of COPD confirmed on spirometry.

You may not qualify if:

  • previous diagnosis of asthma
  • have attended a pulmonary rehabilitation program in the last two years
  • exacerbation of COPD within the last four weeks
  • have comorbidities which prevent participation in an exercise training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Related Publications (8)

  • Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

    PMID: 33511633DERIVED

  • Grimwood CL, Holland AE, McDonald CF, Mahal A, Hill CJ, Lee AL, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, Burge AT. Comparison of self-report and administrative data sources to capture health care resource use in people with chronic obstructive pulmonary disease following pulmonary rehabilitation. BMC Health Serv Res. 2020 Nov 23;20(1):1061. doi: 10.1186/s12913-020-05920-0.

    PMID: 33228654DERIVED

  • Burge AT, Holland AE, McDonald CF, Abramson MJ, Hill CJ, Lee AL, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, Mahal A. Home-based pulmonary rehabilitation for COPD using minimal resources: An economic analysis. Respirology. 2020 Feb;25(2):183-190. doi: 10.1111/resp.13667. Epub 2019 Aug 16.

    PMID: 31418515DERIVED

  • Hoaas H, Zanaboni P, Hjalmarsen A, Morseth B, Dinesen B, Burge AT, Cox NS, Holland AE. Seasonal variations in objectively assessed physical activity among people with COPD in two Nordic countries and Australia: a cross-sectional study. Int J Chron Obstruct Pulmon Dis. 2019 Jun 5;14:1219-1228. doi: 10.2147/COPD.S194622. eCollection 2019.

    PMID: 31239657DERIVED

  • Lahham A, McDonald CF, Mahal A, Lee AL, Hill CJ, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Gillies R, Holland AE. Participation in Physical Activity During Center and Home-Based Pulmonary Rehabilitation for People With COPD: A SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2019 Mar;39(2):E1-E4. doi: 10.1097/HCR.0000000000000373.

    PMID: 30688793DERIVED

  • Liacos A, McDonald CF, Mahal A, Hill CJ, Lee AL, Burge AT, Moore R, Nicolson C, O'Halloran P, Cox NS, Lahham A, Gillies R, Holland AE. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool predicts reduction in sedentary time following pulmonary rehabilitation in people with chronic obstructive pulmonary disease (COPD). Physiotherapy. 2019 Mar;105(1):90-97. doi: 10.1016/j.physio.2018.07.009. Epub 2018 Aug 3.

    PMID: 30316548DERIVED

  • Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Cox NS, Moore R, Nicolson C, O'Halloran P, Lahham A, Gillies R, McDonald CF. Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax. 2017 Jan;72(1):57-65. doi: 10.1136/thoraxjnl-2016-208514. Epub 2016 Sep 26.

    PMID: 27672116DERIVED

  • Holland AE, Mahal A, Hill CJ, Lee AL, Burge AT, Moore R, Nicolson C, O'Halloran P, Cox NS, Lahham A, Ndongo R, Bell E, McDonald CF. Benefits and costs of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease - a multi-centre randomised controlled equivalence trial. BMC Pulm Med. 2013 Sep 8;13:57. doi: 10.1186/1471-2466-13-57.

    PMID: 24011178DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor ActivityDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Anne E Holland, PhD

    La Trobe University, Alfred Health, Institute for Breathing and Sleep

    PRINCIPAL INVESTIGATOR

  • Christine F McDonald, PhD

    Austin Health, Institute for Breathing and Sleep

    PRINCIPAL INVESTIGATOR

  • Ajay Mahal, PhD

    Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 25, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

AU(2)