Exercise for Patients With HIV Infections
Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Unknown status
CT.gov ID
NCT00910936
Collaborator
(none)
60
1
2
9.1
6.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.
Study Start Date
:
May 1, 2009
Anticipated Primary Completion Date
:
Jan 1, 2010
Anticipated Study Completion Date
:
Feb 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention
|
Behavioral: Exercise
12 weeks endurance training, 3 times weekly for 35 minutes
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- Maximal oxygen uptake (VO2max) [At recruitment and after 12 weeks]
Secondary Outcome Measures
- Quality of life [At recruitment and after 12 weeks]
- Indicators of fat metabolism [At recruitment and after 12 weeks]
- Markers of inflammation [At recruitment and after 12 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 | Berlin | Germany | 12200 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
- Principal Investigator: Fernando Dimeo, MD, Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00910936
Other Study ID Numbers:
- EA04/050/07
First Posted:
Jun 1, 2009
Last Update Posted:
Dec 21, 2009
Last Verified:
Dec 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: