NCT00910936

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started May 2009

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 21, 2009

Status Verified

December 1, 2009

Enrollment Period

8 months

First QC Date

May 29, 2009

Last Update Submit

December 18, 2009

Conditions

HIV InfectionsLipodystrophyInflammation

Keywords

HIVExerciseInflammationQuality of lifeLipodystrophia

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake (VO2max)

    At recruitment and after 12 weeks

Secondary Outcomes (3)

  • Quality of life

    At recruitment and after 12 weeks

  • Indicators of fat metabolism

    At recruitment and after 12 weeks

  • Markers of inflammation

    At recruitment and after 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Exercise

Control

NO INTERVENTION

Interventions

ExerciseBEHAVIORAL

12 weeks endurance training, 3 times weekly for 35 minutes

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 65
  • HIV infection
  • Antiviral therapy
  • Understanding of written German

You may not qualify if:

  • Diabetes mellitus
  • All conditions which can be aggravated by exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

HIV InfectionsLipodystrophyInflammationMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fernando Dimeo, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Dimeo, MD

CONTACT

+493084452098fernando.dimeo@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 1, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

December 21, 2009

Record last verified: 2009-12

Locations

DE(1)