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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
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/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

Summary results
Other publications