Clinical trial NCT00157170: The Effects of a Supervised Exercise Program on Self Efficacy of People Living With HIV/AIDS.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: exercise
self efficacy
quality of life
HIV
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-12
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: All outcomes measured at baseline, 2 and 6 months.Self-efficacy measured by the General Self-Efficacy(GSE) Scale.
Secondary outcomes:
measure: Quality of life measured by MOS-HIV Scale. Cardiovascular fitness measured by the Kasch Pulse Recovery Test.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Bayside Health
name: Soula Fillipas, BPhysio MPH
role: PRINCIPAL_INVESTIGATOR
References: