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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00157170
Registration number
NCT00157170
Ethics application status
Date submitted
9/09/2005
Date registered
12/09/2005
Date last updated
21/10/2005
Titles & IDs
Public title
The Effects of a Supervised Exercise Program on Self Efficacy of People Living With HIV/AIDS.
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Scientific title
The Effects of a Supervised Exercise Program on Self Efficacy, Quality of Life Status, Cardiovascular Fitness and Hospital Readmission Rates of People Living With HIV/AIDS.
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Secondary ID [1]
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92/02
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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:
HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - supervised exercise
Behaviour: supervised exercise
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All outcomes measured at baseline, 2 and 6 months.Self-efficacy measured by the General Self-Efficacy(GSE) Scale.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Quality of life measured by MOS-HIV Scale. Cardiovascular fitness measured by the Kasch Pulse Recovery Test.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
HIV, aged at least 18 years
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- any contraindications to exercise testing and training , severe cognitive impairment
- inability to follow instructions,
- regular exercise ( participating in 2 or more structured exercise sessions weekly for
more than or equal to 6 months prior to enrolment).
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2002
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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
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the impact of a supervised exercise program (SEP) on self-efficacy,quality of
life status and cardiovascular fitness among people with HIV in a 24 week randomised
controlled trial.We hypothesised that a combined aerobic and resisted exercise (intervention)
would improve these parameters compared to an individual walking program with monthly group
forum (control).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00157170
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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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Soula Fillipas, BPhysio MPH
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Address
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Bayside Health
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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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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00157170
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