Exercise for Patients With HIV Infections

December 18, 2009 updated by: Charite University, Berlin, Germany

Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.

The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 65
  • HIV infection
  • Antiviral therapy
  • Understanding of written German

Exclusion Criteria:

  • Diabetes mellitus
  • All conditions which can be aggravated by exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Exercise
12 weeks endurance training, 3 times weekly for 35 minutes
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal oxygen uptake (VO2max)
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks
Indicators of fat metabolism
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks
Markers of inflammation
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

February 1, 2010

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Estimate)

December 21, 2009

Last Update Submitted That Met QC Criteria

December 18, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA04/050/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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