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

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157170
• Other study ID #: 92/02
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: October 19, 2005
• Start date: September 2002
• Est. completion date: May 2005

Study information

• Verified date: May 2005
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• supervised exercise

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All outcomes measured at baseline, 2 and 6 months.Self-efficacy measured by the General Self-Efficacy(GSE) Scale.
Secondary	Quality of life measured by MOS-HIV Scale. Cardiovascular fitness measured by the Kasch Pulse Recovery Test.