NCT00157170

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

October 21, 2005

Status Verified

May 1, 2005

First QC Date

September 9, 2005

Last Update Submit

October 19, 2005

Conditions

HIV Infections

Keywords

exerciseself efficacyquality of lifeHIV

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

supervised exerciseBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV, aged at least 18 years

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

HIV InfectionsMotor Activity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Officials

  • Soula Fillipas, BPhysio MPH

    Bayside Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

September 1, 2002

Study Completion

May 1, 2005

Last Updated

October 21, 2005

Record last verified: 2005-05

Locations

AU(1)