Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000416998
Ethics application status
Approved
Date submitted
20/04/2011
Date registered
20/04/2011
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise in Interstitial Lung Disease
Scientific title
Defining the benefit of exercise training in interstitial lung disease. A multi-centre randomised controlled trial.
Secondary ID [1] 260024 0
Nil
Universal Trial Number (UTN)
U1111-1120-8387
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial Lung disease 265683 0
Condition category
Condition code
Respiratory 265821 265821 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Exercise training (ET) group will undergo a twice-weekly exercise training program a for a period of 8 weeks. The ET will be conducted in a group setting and will be individually prescribed, monitored and progressed by an experienced exercise physiologist or physiotherapist according to the protocol. The exercise training will consist of 30 minutes of aerobic exercise at each session, comprising of 15 minutes each of stationary cycling and walking, either on the treadmill or along a corridor depending of the capability of the individual. The initial walking intensity will be set a speed that is 80% of the peak walking speed (km/hr) achieved on the 6minute walk test. The stationary cycling will be set at an intensity that will elicit a 3-4 on the BORG modified scale (0-10). Upper and lower limb resistance training (RT) exercises using dumbbell hand weights will also be included. Heart rate, SpO2 and shortness of breath will be monitored during each session. All exercise modalities will be progressed each week with the goal of achieving dyspnoea score of 3-4 on each occasion. Supplemental oxygen will be provided during training to maintain SpO2>85%.

Once the subject is safely established on a supervised exercise regimen, an unsupervised home exercise program will be prescribed to achieve two additional home-based sessions per week. Home exercise will be monitored using an exercise diary and reviewed weekly by the supervising clinician. At the conclusion of the 8-week program, subjects will be encouraged to continue with an unsupervised home exercise program at least three times per week.
Intervention code [1] 264445 0
Treatment: Other
Comparator / control treatment
The control group will not undergo any exercise training but will be contacted weekly by telephone to provide general support for the duration of the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 266578 0
Change in functional exercise capacity measured with 6 minute walk test according to standardised criteria.
Timepoint [1] 266578 0
At baseline, post 8 weeks intervention and 6 months following intervention.
Secondary outcome [1] 276054 0
Change in peripheral Muscle strength measured using a hand held dynamometer.
Timepoint [1] 276054 0
At baseline, post 8weeks intervention and 6 months following intervention.
Secondary outcome [2] 276055 0
Health-related Quality of Life (HRQOL) measured using with the Chronic Respiratory Disease Questionnaire (CRQ), and St George Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I).
Timepoint [2] 276055 0
At baseline, post 8 weeks intervention and 6 months following intervention.
Secondary outcome [3] 276056 0
Dyspnoea measured using the University of California San Diego Shortness of breath questionnaire (UCSD SOBQ).disease.
Timepoint [3] 276056 0
At baseline, post 8 weeks intervention and 6 months following intervention.
Secondary outcome [4] 276057 0
Standard spirometry, lung volumes and transfer factor for carbon monoxide (TLCO) will be measured to quantify disease severity.
Timepoint [4] 276057 0
Spirometry and TLCO will be measured at baseline and 6 months following intervention. Lung volumes will be measured at baseline only.
Secondary outcome [5] 276058 0
Trans-thoracic echocardiogram will be performed to quantify the degree of pulmonary hypertension.
Timepoint [5] 276058 0
At baseline only

Eligibility
Key inclusion criteria
Patients with documented interstitial lung disease, who are ambulant and suffer from dyspnoea on exertion despite maximal medical treatment
Minimum age
30 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have a history of syncope on exertion, are too unwell to attend the hospital for exercise training or have any other comorbidities which would prevent Exercise training such as severe orthopaedic or neurological deficits or unstable cardiac disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes containing group allocation will be opened by an individual unrelated to the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a computer generated list of random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
11/11/2011
Date of last participant enrolment
Anticipated
30/04/2014
Actual
19/06/2014
Date of last data collection
Anticipated
Actual
26/02/2015
Sample size
Target
116
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 264914 0
Government body
Name [1] 264914 0
NHMRC
Country [1] 264914 0
Australia
Primary sponsor type
Individual
Name
Leona Dowman
Address
La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
PRAHRAN VICTORIA 3181
Country
Australia
Secondary sponsor category [1] 264015 0
University
Name [1] 264015 0
La Trobe University
Address [1] 264015 0
c/- La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran VICTORIA 3181
Country [1] 264015 0
Australia
Secondary sponsor category [2] 264035 0
None
Name [2] 264035 0
Address [2] 264035 0
Country [2] 264035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266875 0
Austin Health Human Research Ethics Commitee
Ethics committee address [1] 266875 0
Ethics committee country [1] 266875 0
Australia
Date submitted for ethics approval [1] 266875 0
20/04/2011
Approval date [1] 266875 0
18/07/2011
Ethics approval number [1] 266875 0
Ethics committee name [2] 266895 0
Alfred Hospital Human Research Ethics Commitee
Ethics committee address [2] 266895 0
Ethics committee country [2] 266895 0
Australia
Date submitted for ethics approval [2] 266895 0
23/05/2011
Approval date [2] 266895 0
23/07/2011
Ethics approval number [2] 266895 0
Ethics committee name [3] 266896 0
La Trobe University
Ethics committee address [3] 266896 0
Ethics committee country [3] 266896 0
Australia
Date submitted for ethics approval [3] 266896 0
02/05/2011
Approval date [3] 266896 0
07/11/2011
Ethics approval number [3] 266896 0
Ethics committee name [4] 290377 0
Western Health Low Risk Human Research Ethics Panel
Ethics committee address [4] 290377 0
Ethics committee country [4] 290377 0
Australia
Date submitted for ethics approval [4] 290377 0
21/07/2011
Approval date [4] 290377 0
08/08/2011
Ethics approval number [4] 290377 0
HREC/11/WH/58

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32509 0
A/Prof Anne Holland
Address 32509 0
La Trobe Uni/Alfred Health Clinic School
Level 4, Alfred Centre
99 Commercial Rd
Prahran
Vic 3181
Country 32509 0
Australia
Phone 32509 0
+613 9479 6744
Fax 32509 0
Email 32509 0
[email protected]
Contact person for public queries
Name 15756 0
Leona Dowman
Address 15756 0
La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran VICTORIA 3181
Country 15756 0
Australia
Phone 15756 0
+ 61 3 9749 6747
Fax 15756 0
+ 61 3 9749 2104
Email 15756 0
[email protected]
Contact person for scientific queries
Name 6684 0
Leona Dowman
Address 6684 0
La Trobe / Alfred Health Clinical School
Level 4, The Alfred Centre
99 Commercial Road
Prahran VICTORIA 3181
Country 6684 0
Australia
Phone 6684 0
+ 61 3 9749 6747
Fax 6684 0
+ 61 3 9749 2104
Email 6684 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe benefits of exercise training in interstitial lung disease: protocol for a multicentre randomised controlled trial2013https://doi.org/10.1186/1471-2466-13-8
EmbaseReliability of the hand held dynamometer in measuring muscle strength in people with interstitial lung disease.2016https://dx.doi.org/10.1016/j.physio.2015.10.002
N.B. These documents automatically identified may not have been verified by the study sponsor.