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Trial registered on ANZCTR
Registration number
ACTRN12611000644965
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
23/06/2011
Date last updated
23/06/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Longer versus shorter duration exercise rehabilitation following lung transplantation
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Scientific title
Effect of a 7 week versus 14 week exercise rehabilitation program on functional capacity in patients following lung transplantation
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Secondary ID [1]
262428
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
rehabilitaion duration following lung transplant
4618
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Condition category
Condition code
Physical Medicine / Rehabilitation
4918
4918
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
cardiovascular exercise on a treadmill and bike ergometer,muscle strength training exercises including squats,step ups, resisted weight training for legs, arms and core muscles for 1 hour ,3 times a week for a total of 7 weeks in a class setting run by a senior physiotherapist.
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Intervention code [1]
4379
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Rehabilitation
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Comparator / control treatment
The same cardiovascular and strength program with only difference that the control group attend for14 weeks.
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Control group
Active
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Outcomes
Primary outcome [1]
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functional exercise capacity with a 6 minute walk test,
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Assessment method [1]
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Timepoint [1]
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7 ,14 weeks & 6 mnths after the commencement of rehabilitation.
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Secondary outcome [1]
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strength of hamstrings and quadriceps muscles on an isokinetic dynamometer
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Assessment method [1]
241720
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Timepoint [1]
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7, 14 weeks & 6 months after the commencement of rehabilitation
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Secondary outcome [2]
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quality of life questionnaire - short form 36
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Assessment method [2]
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Timepoint [2]
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7, 14 weeks & 6 months after the commencement of rehabilitation
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Eligibility
Key inclusion criteria
lung transplant for conditions other than pulmonary hypertension & heart lung transplant
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
lung transplant for pulmonary hypertension, heart lung transplant admission to an inpatient facility & non victorian patients
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who have had a lung transplant in the Allergy, Immunology and Respiratory medicine(AIRMED)department of the Alfred hospital will be invited to join study towards the end of in patient(IP) stay.Allocation was by concealed, computer generated allocation in sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to a group by individual unrelated to trial who will open a sealed opaque envelope. Stratified for participants with cystic fibrosis to ensure an even spread of younger participants
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
18/05/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
66
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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The Alfred Hospital
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Address [1]
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Commercial Road
Melbourne 3181
Victoria
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
The Alfred Hospital
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Address
Commercial Road
Melbourne 3181
Victoria
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
4334
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Country [1]
4334
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Alfred Hospital Ethics Committee
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Ethics committee address [1]
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Commercial Road
Melbourne 3181
Victoria
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
6847
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Approval date [1]
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23/02/2009
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Ethics approval number [1]
6847
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Summary
Brief summary
The researchers wish to compare the outcomes of a longer duration(14weeks) to a shorter duration (7weeks) exercise rehabilitation following lung transplantation. Those who give informed consent will be randomised to longer or shorter programs and will be over 18years of age. All participants will undergo standard exercise program for 7 weeks, comprising thrice weekly supervised exercise in the physiotherapy department. The longer duration will receive a further 7 weeks of exercise training. Both groups will receive standard post transplant education sessions and maintain an exercise diary. Functional exercise capacity, lower limb strength training and quality of life measures will be obtained at baseline, 7 weeks, 14 weeks and 6 months. At present there is no data describibg the likely magnitude of differences in outcomes between longer and shorter rehabilitation programs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Louise Fuller
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Address
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Physiothrapy Department
The Alfred Hospital
Commercial Road
Melbourne 3181
Victoria
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Country
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Australia
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Phone
12748
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+ 61 3 9076 3450
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Fax
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+ 61 3 9076 2702
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Email
12748
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[email protected]
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Contact person for scientific queries
Name
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Louise Fuller
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Address
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Physiotherapy Department
The Alfred Hospital
Commercial Rd
Melbourne 3181
Victoria
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Country
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Australia
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Phone
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+ 61 3 9076 3450
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Fax
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+ 61 3 9076 2702
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Email
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[email protected]
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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
No additional documents have been identified.
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