Trial document





This trial has been registered retrospectively.
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  DRKS00011592

Trial Description

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Title

An epidemiologic study on the effects of HIV-infection on oxidative stress and of moderate endurance training (marathon) on immune function - The 42 KM Cologne Project

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Trial Acronym

HIV and Marathon

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Effects of moderate indurance Training over 1 year on immunologic and metabolic Parameters in HIV-infected patients were measured, as data on effects of sports in HIV-patients are scarce.

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Brief Summary in Scientific Language

The face of HIV infection has changed dramatically over the past decade. Due to continuous improvements in ART life expectancy approaches to that of the general population in most developed countries. Quality of life has also improved for most treated patients, who are able to participate in daily activities without restrictions. Amongst other activities, strenuous exercise is undertaken by an increasing proportion of patients. However, HIV research has focused mainly on ART and associated problems such as efficacy, safety and tolerability, long term toxicities and since recently prophylaxis. Little is known about effects of usual activities such as exercise on HIV-associated clinical parameters and health state.

Effects of physical exercise on health have been discussed for decades. Most studies performed have focussed on cardiovascular disease. Impact of physical activities has been studied in other chronic diseases such as chronic obstructive pulmonary disease, chronic kidney disease, asthma and osteoporosis, diabetes type 2, colon cancer and dementia. Studies in HIV-infected patients were conducted in the pre-ART era or addressed typical complications of HIV-infected patients such as wasting, lipodystrophy, anxiety, depression or HIV-associated neurocognitive disorder (HAND). However, studies on effects of physical exercise beyond the treatment of HIV-associated complications are scarce.

In the present study, we assessed the effects of moderate endurance training on HIV-infected persons. We analysed immunological and metabolic data of HIV-infected subjects performing regular moderate aerobic exercise over a period of one year their aim of running a marathon.

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Organizational Data

  •   DRKS00011592
  •   2017/02/09
  •   [---]*
  •   yes
  •   Approved
  •   138/09, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   B23.8 -  HIV disease resulting in other specified conditions
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Interventions/Observational Groups

  •   HIV-infected patients prepare for a marathon run over a period of 1 year. Participants train three to four times per week following individual training plans provided (3 to 4 hours per week at 60-70% of maximum heart rate at the beginning, increasing up to 70-80% for up to 10 hours per week).
    Main goal of this training - adpated throughout the training period - is to improve aerobic metabolism capacity, threshold performance and anaerobic glycolysis.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

CD4 cell count, viral load 12, 9, and 6 months and right before the marathon run. Number and severity of infections during the whole observation period and 4 weeks afterwards.

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Secondary Outcome

Metabolic Parameters (lipids, glucose), safety Parameters (liver transaminases, creatinkinase, Phosphate), immunologic Parameters (CD4T-cell apoptosis), oxidative stress and antioxidative capacity (with photometric analysis of capillary blood); quality of life with Medical Outcomes Study HIV Health Survey (MOS-HIV) 12, 9, and 6 months and right before the marathon run

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/08/28
  •   21
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- HIV-infection
- certificate of the treating HIV-specialist that participation in marathon and lactacte stress test is possible
- signed informed consent form before inclusion

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Exclusion Criteria

- younger than 18 years
- missing health certificate
- obvious reason not to participate in Marathon running
- new AIDS-defining event ≤ 1 months before inclusion
- malignant disease with current chemotherapy
- organ transplant
- Treatment with systemic corticosteroids ≤ 3 months before inclusion

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Addresses

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    • Universitätsklinikum BonnMedizinische Klinik I
    • PD Dr. med.  Jan-Christian  Wasmuth 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn
    • Mr.  PD Dr. med.  Jan-Christian  Wasmuth 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn
    • Mr.  Dr. med.  Martin  Vogel 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Abbott GmbH & Co. KG
    • Max-Planck-Ring 2
    • 65205  Wies­baden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2010/08/07
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.