Exercise for Patients With HIV Infections

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00910936
• Other study ID #: EA04/050/07
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 29, 2009
• Last updated: December 18, 2009
• Start date: May 2009
• Est. completion date: February 2010

Study information

• Verified date: December 2009
• Source: Charite University, Berlin, Germany
• Contact: Fernando Dimeo, MD
• Phone: +493084452098
• Email: fernando.dimeo[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection
• Inflammation
• Lipodystrophy

Intervention

Behavioral:
• Exercise
12 weeks endurance training, 3 times weekly for 35 minutes

Locations

Country	Name	City	State
Germany	Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal oxygen uptake (VO2max)		At recruitment and after 12 weeks	No
Secondary	Quality of life		At recruitment and after 12 weeks	No
Secondary	Indicators of fat metabolism		At recruitment and after 12 weeks	No
Secondary	Markers of inflammation		At recruitment and after 12 weeks	No