Pulmonary Rehabilitation in Interstitial Lung Disease | NCT00168285

Studies
Pulmonary Rehabilitation in Interstitial Lung Disease

NCT00168285

Sponsor

The Alfred

Status

Unknown status

Last Update Posted

Apr 5, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Interstitial Lung Disease

Interventions

Pulmonary Rehabilitation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

May 2007Estimated

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2007

Last Update Posted Date

Apr 5, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

The AlfredOTHER

Collaborators

Name	Class
La Trobe University	OTHER
Austin Hospital, Melbourne Australia	OTHER
Victorian Tuberculosis and Lung Association	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary Rehabilitation	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional exercise capacity

Secondary Outcomes

Measure	Description	Time Frame
Maximal exercise capacity
Health-related quality of life
Dyspnoea

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulant
Stable medical therapy
Dyspnoea on exertion following maximal treatment

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alfred Hospital		Melbourne	Victoria	3004	Australia
Austin Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18245143	Derived	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.

ID	Term
D017563	Lung Diseases, Interstitial
D009043	Motor Activity
D054990	Idiopathic Pulmonary Fibrosis
D003240	Connective Tissue Diseases

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D001519	Behavior
D011658	Pulmonary Fibrosis