The Effects of a Supervised Exercise Program on Self Efficacy of People Living With HIV/AIDS.
|First Received Date ICMJE||September 9, 2005|
|Last Updated Date||October 19, 2005|
|Start Date ICMJE||September 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||All outcomes measured at baseline, 2 and 6 months.Self-efficacy measured by the General Self-Efficacy(GSE) Scale.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00157170 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Quality of life measured by MOS-HIV Scale. Cardiovascular fitness measured by the Kasch Pulse Recovery Test.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effects of a Supervised Exercise Program on Self Efficacy of People Living With HIV/AIDS.|
|Official Title ICMJE||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.|
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).
With combination antiretroviral therapy, HIV has become a chronic, manageable medical condition. Medication adherence is now a critical determinant of patient outcomes. Quality of life (QOL) rather than just survival has also become an important consideration in HIV management strategies. The role of non-pharmacological interventions such as exercise to enhance self efficacy (which correlates with adherence) and QOL among people with HIV requires formal investigation.
We evaluated the impact of a supervised exercise program (SEP) on self-efficacy among people with HIV in a 24 week, randomised controlled trial of participation in a SEP with combined aerobic and resisted exercise (intervention) versus an individual walking program with monthly group forum (control). QOL and cardiovascular fitness were also evaluated as secondary endpoints. Twenty subjects were enrolled in each arm, and assessments were performed at baseline, 2 month and 6 months, including a Generic Self Efficacy Scale, 1 minute heart rate response post 3 minute step test, and a validated HIV-specific QOL survey.
Self efficacy and cardiovascular fitness improved in the intervention but not the control subjects over the study period (p<0.0001 for both). QOL also improved (8 out of 10 dimensions) in the intervention group but not in controls (0 out of 10 dimensions).
These data support the use of SEP as an important therapeutic intervention for people with HIV, with significant benefits to self efficacy, cardiovascular fitness and QOL over six months. Importantly, these benefits were not achieved through unsupervised exercise over the same period.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Behavioral: supervised exercise|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||May 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
HIV, aged at least 18 years
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Australia|
|NCT Number ICMJE||NCT00157170|
|Other Study ID Numbers ICMJE||92/02|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Bayside Health|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Bayside Health|
|Verification Date||May 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP