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Exercise for Patients With HIV Infections

Primary Purpose

HIV Infections, Lipodystrophy, Inflammation

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Exercise
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring HIV, Exercise, Inflammation, Quality of life, Lipodystrophia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Maximal oxygen uptake (VO2max)

Secondary Outcome Measures

Quality of life
Indicators of fat metabolism
Markers of inflammation

Full Information

First Posted
May 29, 2009
Last Updated
December 18, 2009
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00910936
Brief Title
Exercise for Patients With HIV Infections
Official Title
Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipodystrophy, Inflammation
Keywords
HIV, Exercise, Inflammation, Quality of life, Lipodystrophia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
12 weeks endurance training, 3 times weekly for 35 minutes
Primary Outcome Measure Information:
Title
Maximal oxygen uptake (VO2max)
Time Frame
At recruitment and after 12 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
At recruitment and after 12 weeks
Title
Indicators of fat metabolism
Time Frame
At recruitment and after 12 weeks
Title
Markers of inflammation
Time Frame
At recruitment and after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de

12. IPD Sharing Statement

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Exercise for Patients With HIV Infections

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