Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000742279
Ethics application status
Approved
Date submitted
2/06/2009
Date registered
26/08/2009
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can exercise training improve cardiovascular fitness and quality of life in patients with a left ventricular assist device (LVAD)?
Scientific title
Can exercise training improve cardiovascular fitness and quality of life in patients with a left ventricular assist device (LVAD)?
Secondary ID [1] 259731 0
Nil secondary ID
Universal Trial Number (UTN)
U1111-1119-7295
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with end stage heart failure, requiring a LVAD as a bridge to heart transplantation 236909 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237264 237264 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 weeks of gym-based exercise training, consisting of both cardiovascular and resistance training, 3 times a week for an hour each sessio. In addition, subjects will participate in a progressive walking program consisting of daily walking at a rate of perceived exertion of 13 on the Borg scale, increasing duration at this intensity. Initially patients may only be walking for 5 minutes, and this duration will be increased on an individul basis. subjects will complete the walking program for 8 weeks.
Intervention code [1] 236697 0
Rehabilitation
Comparator / control treatment
Progressive walking program consisting of daily walking at a rate of perceived exertion of 13 on the Borg scale, increasing duration at this intensity. Initially patients may only be walking for 5 minutes, and this duration will be increased on an individul basis. subjects will complete the walking program for 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 238079 0
Maximal oxygen consumption (VO2 peak)
Timepoint [1] 238079 0
At the start and end of 8 week intervention period
Secondary outcome [1] 242272 0
6 minute walk distance assessing submaximal exercise capacity
Timepoint [1] 242272 0
start and end of 8 week intervention period
Secondary outcome [2] 257304 0
Quality of life scores using the 36 item, medical outcomes study short form general health survey (SF 36)
Timepoint [2] 257304 0
start and end of the 8 week intervention period

Eligibility
Key inclusion criteria
patients with severe heart failure who have had an LVAD implanted as a bridge to heart transplantation
clinically stable/stable medical management
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. exercise-induced myocardial ischaemia or significant arrhythmias
2. significant neurological impairment which would preclude participation in the exercise program and necessitate specific neuro-rehabilitation
3. musculoskeletal or respiratory problems or other co-morbidities that precludes exercise

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)
The allocation sequence will be concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
subjects will be randomly assigned via a computerised algorithm to either the eight week mobilization program or the eight-week aerobic and strength training program in addition to the mobilization program.
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
1/07/2009
Actual
3/08/2009
Date of last participant enrolment
Anticipated
Actual
1/02/2011
Date of last data collection
Anticipated
Actual
29/03/2011
Sample size
Target
14
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237087 0
Hospital
Name [1] 237087 0
Alfred Hospital
Country [1] 237087 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 commercial Rd, Prahran, Victoria 3181
Country
Australia
Secondary sponsor category [1] 4592 0
None
Name [1] 4592 0
Address [1] 4592 0
Country [1] 4592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239190 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 239190 0
55 Commercial Road, Melbourne, Victoria
Ethics committee country [1] 239190 0
Australia
Date submitted for ethics approval [1] 239190 0
03/06/2009
Approval date [1] 239190 0
30/06/2009
Ethics approval number [1] 239190 0
185/09

Summary
Brief summary
The purpose of this study is to examine the effect of an eight week cardiovascular and strengthening exercise program on maximum exercise capacity (VO2 peak), quality of life scores and six minute walk distance in patients with a LVAD. The experimental hypothesis is that patients with a LVAD who participate in the eight week gym-based exercise program, in addition to a progressive walking program, will have significantly greater improvements in maximal and submaximal exercise capacity and quality of life compared to those that participate in a progressive walking program alone.
Trial website
Trial related presentations / publications
J Heart Lung Transplant 2012;31:729–34
Public notes

Contacts
Principal investigator
Name 29688 0
Address 29688 0
Country 29688 0
Phone 29688 0
Fax 29688 0
Email 29688 0
Contact person for public queries
Name 12935 0
Kathryn Hayes
Address 12935 0
Physiotherapy Department, The Alfred Hospital, 55 commercial Rd, Prahran, Victoria 3181
Country 12935 0
Australia
Phone 12935 0
+61 3 90763450
Fax 12935 0
Email 12935 0
[email protected]
Contact person for scientific queries
Name 3863 0
Kathryn Hayes
Address 3863 0
Physiotherapy Department, The Alfred Hospital, 55 commercial Rd, Prahran, Victoria 3181
Country 3863 0
Australia
Phone 3863 0
+61 3 90763450
Fax 3863 0
Email 3863 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
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Documents added automatically
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