Interstitial Lung DiseaseNCT00168285
Pulmonary Rehabilitation in Interstitial Lung Disease
A study testing Pulmonary Rehabilitation in people with Interstitial Lung Disease, run by The Alfred at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 2 sitesAustralia
- Study dates
- Mar 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulant
- Stable medical therapy
- Dyspnoea on exertion following maximal treatment
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Alfred Hospital
Melbourne, Victoria, 3004
Austin Hospital
Melbourne, Victoria, 3084
About this study
Official title: Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial
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.
Read the detailed description
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 and reduces health-related quality of life.Available treatments for ILD have proved largely ineffective, offering no improvement in survival and demonstrating only limited impact on quality of life.
Aims of the Research
- Evaluate the effects of Pulmonary Rehabilitation on exercise capacity and quality of life in patients with ILD
- Determine the physiological response to Pulmonary Rehabilitation in patients with ILD
- Determine the relationship between the aetiology and severity of ILD and the effects of Pulmonary Rehabilitation.
Comparisons: 8 weeks exercise training compared to control group (maximal exercise capacity, functional exercise capacity, dyspnoea, quality of life).
- Conditions
- Interstitial Lung Disease
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Exercise, Pulmonary rehabilitation, Idiopathic pulmonary fibrosis, Connective tissue disorders
- Medical subject headings
- Lung Diseases, Interstitial, Motor Activity, Idiopathic Pulmonary Fibrosis, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Secondary outcomes (3)
Maximal exercise capacity
Health-related quality of life
Dyspnoea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Study completionMay 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 56 participants
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Collaborators
- La Trobe University, Austin Hospital, Melbourne Australia, Victorian Tuberculosis and Lung Association
- Investigators
- Anne E Holland, PhD, Principal investigator, Alfred Hospital and LaTrobe UniversityMatthew Conron, MBBS, Principal investigator, The AlfredPrue Munro, BAppSc, Principal investigator, The AlfredChristine McDonald, MBBS PhD, Principal investigator, Austin Hospital, Melbourne AustraliaCatherine Hill, PhD, Principal investigator, Austin Hospital, Melbourne Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168285
- Sponsor's protocol ID
- PRIDe
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 5 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18245143
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in Interstitial Lung Disease - a Multi-Centre, Single-Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00168285
- Acronym / sponsor ID
- PRIDe
- Conditions
- Interstitial Lung Disease
- Keywords
- Exercise, Pulmonary rehabilitation, Idiopathic pulmonary fibrosis, Connective tissue disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants
- Lead sponsor
- The AlfredUniversity, hospital or other
- Collaborators
- La Trobe University, Austin Hospital, Melbourne Australia, Victorian Tuberculosis and Lung Association
- Study start
- Mar 2005
- Study completion
- May 2007 (estimated)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 and reduces health-related quality of life.Available treatments for ILD have proved largely ineffective, offering no improvement in survival and demonstrating only limited impact on quality of life.
Aims of the Research
- Evaluate the effects of Pulmonary Rehabilitation on exercise capacity and quality of life in patients with ILD
- Determine the physiological response to Pulmonary Rehabilitation in patients with ILD
- Determine the relationship between the aetiology and severity of ILD and the effects of Pulmonary Rehabilitation.
Comparisons: 8 weeks exercise training compared to control group (maximal exercise capacity, functional exercise capacity, dyspnoea, quality of life).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulant
- Stable medical therapy
- Dyspnoea on exertion following maximal treatment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation | Behavioural | – |
Primary outcome
Functional exercise capacity
3 secondary outcomes
Maximal exercise capacity
Health-related quality of life
Dyspnoea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2007.
- Derived from this study: PubMed 18245143Holland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne E Holland, PhD principal investigator
Alfred Hospital and LaTrobe University
Matthew Conron, MBBS principal investigator
The Alfred
Prue Munro, BAppSc principal investigator
The Alfred
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Interstitial Lung Disease, run by The Alfred at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2007.