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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
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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
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
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

No publications provided

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
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 March 07, 2013