NCT00168285

Brief Summary

Interstitial lung disease (ILD) is a highly disabling group of conditions including idiopathic pulmonary fibrosis (IPF), acute and chronic interstitial pneumonias, connective tissue diseases and sarcoidosis. People with ILD frequently experience breathlessness on exertion, which limits their ability to undertake daily activities. People with ILD report very poor quality of life due to low levels of physical functioning and vitality, and high levels of breathlessness and fatigue. There are few treatments for ILD and those that are available have limited impact on quality of life. The aim of this study is to assess the effects of Pulmonary Rehabilitation, which consists of specialised exercise training for people with lung disease, on exercise capacity and quality of life in people with ILD. We hypothesis that exercise training will result in reduced dyspnoea, improved exercise tolerance and enhanced quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

April 5, 2007

Status Verified

April 1, 2007

First QC Date

September 13, 2005

Last Update Submit

April 4, 2007

Conditions

Keywords

ExercisePulmonary rehabilitationIdiopathic pulmonary fibrosisConnective tissue disorders

Outcome Measures

Primary Outcomes (1)

  • Functional exercise capacity

Secondary Outcomes (3)

  • Maximal exercise capacity

  • Health-related quality of life

  • Dyspnoea

Interventions

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulant
  • Stable medical therapy
  • Dyspnoea on exertion following maximal treatment

You may not qualify if:

  • A history of syncope on exertion
  • Too unwell to attend the hospital for exercise training
  • Any other comorbidities which would prevent exercise training
  • Previous Pulmonary Rehabilitation in the last 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

Related Publications (1)

  • Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Thorax. 2008 Jun;63(6):549-54. doi: 10.1136/thx.2007.088070. Epub 2008 Feb 1.

MeSH Terms

Conditions

Lung Diseases, InterstitialMotor ActivityIdiopathic Pulmonary FibrosisConnective Tissue Diseases

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesBehaviorPulmonary FibrosisSkin and Connective Tissue Diseases

Study Officials

  • Anne E Holland, PhD

    Alfred Hospital and LaTrobe University

    PRINCIPAL INVESTIGATOR
  • Matthew Conron, MBBS

    The Alfred

    PRINCIPAL INVESTIGATOR
  • Prue Munro, BAppSc

    The Alfred

    PRINCIPAL INVESTIGATOR
  • Christine McDonald, MBBS PhD

    Austin Hospital, Melbourne Australia

    PRINCIPAL INVESTIGATOR
  • Catherine Hill, PhD

    Austin Hospital, Melbourne Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Study Completion

May 1, 2007

Last Updated

April 5, 2007

Record last verified: 2007-04

Locations