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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.
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.
Secondary ID [1] 0 0
92/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - supervised exercise

Behaviour: supervised exercise
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All outcomes measured at baseline, 2 and 6 months.Self-efficacy measured by the General Self-Efficacy(GSE) Scale.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Quality of life measured by MOS-HIV Scale. Cardiovascular fitness measured by the Kasch Pulse Recovery Test.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
HIV, aged at least 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
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).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00157170
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Soula Fillipas, BPhysio MPH
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries