The Effects of a Supervised Exercise Program on Self Efficacy of People Living With HIV/AIDS.

Sponsor
Bayside Health (Other)
Overall Status
Completed
CT.gov ID
NCT00157170
Collaborator
(none)
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: supervised exercise
N/A

Detailed Description

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Primary Purpose:
Treatment
Official 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.
Study Start Date :
Sep 1, 2002
Study Completion Date :
May 1, 2005

Outcome Measures

Primary Outcome Measures

  1. All outcomes measured at baseline, 2 and 6 months.Self-efficacy measured by the General Self-Efficacy(GSE) Scale. []

Secondary Outcome Measures

  1. Quality of life measured by MOS-HIV Scale. Cardiovascular fitness measured by the Kasch Pulse Recovery Test. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

HIV, aged at least 18 years

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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alfred Hospital Melbourne Victoria Australia 3004

Sponsors and Collaborators

  • Bayside Health

Investigators

  • Principal Investigator: Soula Fillipas, BPhysio MPH, Bayside Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00157170
Other Study ID Numbers:
  • 92/02
First Posted:
Sep 12, 2005
Last Update Posted:
Oct 21, 2005
Last Verified:
May 1, 2005
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2005