Exercise for Patients With HIV Infections

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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

Tracking Information

First Received Date ^ICMJE

May 29, 2009

Last Updated Date

December 18, 2009

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

January 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00910936 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of life [ Time Frame: At recruitment and after 12 weeks ]
Indicators of fat metabolism [ Time Frame: At recruitment and after 12 weeks ]
Markers of inflammation [ Time Frame: At recruitment and after 12 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Exercise for Patients With HIV Infections

Official Title ^ICMJE

Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

HIV Infections
Lipodystrophy
Inflammation

Intervention ^ICMJE

Behavioral: Exercise

12 weeks endurance training, 3 times weekly for 35 minutes

Study Arms

Experimental: Intervention
Intervention: Behavioral: Exercise
No Intervention: Control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2010

Estimated Primary Completion Date

January 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 65 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00910936

Other Study ID Numbers ^ICMJE

EA04/050/07

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Dr. Fernando Dimeo, Dept. of Sports Medicine, Charité Universitätsmedizin Berlin

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Fernando Dimeo, MD

Charite University, Berlin, Germany

PRS Account

Charite University, Berlin, Germany

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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