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Exercise for Patients With HIV Infections

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ClinicalTrials.gov Identifier: NCT00910936
Recruitment Status : Unknown
Verified December 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : June 1, 2009
Last Update Posted : December 21, 2009
Sponsor:
Information provided by:

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
HIV Infections Lipodystrophy Inflammation Behavioral: Exercise Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 2009
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 :
  1. Maximal oxygen uptake (VO2max) [ Time Frame: At recruitment and after 12 weeks ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: At recruitment and after 12 weeks ]
  2. Indicators of fat metabolism [ Time Frame: At recruitment and after 12 weeks ]
  3. Markers of inflammation [ Time Frame: At recruitment and after 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: December 21, 2009
Last Verified: December 2009

Keywords provided by Charite University, Berlin, Germany:
HIV
Exercise
Inflammation
Quality of life
Lipodystrophia

Additional relevant MeSH terms:
Infection
Communicable Diseases
Inflammation
HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
Pathologic Processes
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
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases