Trial Review

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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
Scientific title
Effect of a 7 week versus 14 week exercise rehabilitation program on functional capacity in patients following lung transplantation
Secondary ID [1] 262428 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rehabilitaion duration following lung transplant 4618 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4918 4918 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 4379 0
Rehabilitation
Comparator / control treatment
The same cardiovascular and strength program with only difference that the control group attend for14 weeks.
Control group
Active

Outcomes
Primary outcome [1] 5765 0
functional exercise capacity with a 6 minute walk test,
Timepoint [1] 5765 0
7 ,14 weeks & 6 mnths after the commencement of rehabilitation.
Secondary outcome [1] 241720 0
strength of hamstrings and quadriceps muscles on an isokinetic dynamometer
Timepoint [1] 241720 0
7, 14 weeks & 6 months after the commencement of rehabilitation
Secondary outcome [2] 241721 0
quality of life questionnaire - short form 36
Timepoint [2] 241721 0
7, 14 weeks & 6 months after the commencement of rehabilitation

Eligibility
Key inclusion criteria
lung transplant for conditions other than pulmonary hypertension & heart lung transplant
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
lung transplant for pulmonary hypertension, heart lung transplant admission to an inpatient facility & non victorian patients

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)
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.
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4799 0
Hospital
Name [1] 4799 0
The Alfred Hospital
Country [1] 4799 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Commercial Road
Melbourne 3181
Victoria
Country
Australia
Secondary sponsor category [1] 4334 0
None
Name [1] 4334 0
Address [1] 4334 0
Country [1] 4334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6847 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 6847 0
Commercial Road
Melbourne 3181
Victoria
Ethics committee country [1] 6847 0
Australia
Date submitted for ethics approval [1] 6847 0
Approval date [1] 6847 0
23/02/2009
Ethics approval number [1] 6847 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29501 0
Address 29501 0
Country 29501 0
Phone 29501 0
Fax 29501 0
Email 29501 0
Contact person for public queries
Name 12748 0
Louise Fuller
Address 12748 0
Physiothrapy Department
The Alfred Hospital
Commercial Road
Melbourne 3181
Victoria
Country 12748 0
Australia
Phone 12748 0
+ 61 3 9076 3450
Fax 12748 0
+ 61 3 9076 2702
Email 12748 0
[email protected]
Contact person for scientific queries
Name 3676 0
Louise Fuller
Address 3676 0
Physiotherapy Department
The Alfred Hospital
Commercial Rd
Melbourne 3181
Victoria
Country 3676 0
Australia
Phone 3676 0
+ 61 3 9076 3450
Fax 3676 0
+ 61 3 9076 2702
Email 3676 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
No additional documents have been identified.