Exercise for Patients With HIV Infections
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Charite University, Berlin, Germany
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00910936
First received: May 29, 2009
Last updated: December 18, 2009
Last verified: December 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections Lipodystrophy Inflammation |
Behavioral: Exercise |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
| Official Title: | Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection. |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Maximal oxygen uptake (VO2max) [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]
- Indicators of fat metabolism [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]
- Markers of inflammation [ Time Frame: At recruitment and after 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intervention |
Behavioral: Exercise
12 weeks endurance training, 3 times weekly for 35 minutes
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910936
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910936
Contacts
| Contact: Fernando Dimeo, MD | +493084452098 | fernando.dimeo@charite.de |
Locations
| Germany | |
| Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30 | Recruiting |
| Berlin, Germany, 12200 | |
| Contact: Fernando Dimeo, MD +493084452098 fernando.dimeo@charite.de | |
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | Fernando Dimeo, MD | Charite University, Berlin, Germany |
More Information
| Responsible Party: | Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin |
| ClinicalTrials.gov Identifier: | NCT00910936 History of Changes |
| Other Study ID Numbers: | EA04/050/07 |
| Study First Received: | May 29, 2009 |
| Last Updated: | December 18, 2009 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Charite University, Berlin, Germany:
|
HIV Exercise Inflammation Quality of life Lipodystrophia |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Infection Communicable Diseases Inflammation Lipodystrophy Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Pathologic Processes Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on September 27, 2016