Trial document




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  DRKS00005159

Trial Description

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Title

Improvement of endogenous regeneration in female healthy volunteers through physical exercise “REBIRTH aktiv women”

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Trial Acronym

Rebirth women

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URL of the Trial

http://Keine

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Brief Summary in Lay Language

In a pilot study, we have shown that physical training on a regular basis has a significant positive influence on the cardio vascular system in men between 45 and 65 years. Aim of the study is to show that a six month physical training intervention leads to an improvement on aging markers and elevates the peak oxygen consumption in a cohort of 313 female volunteers with a mainly sedentary way of working. Further the influence of chonical inflammation (paradontal status) and the hormonal balance (post menopause) on the training intervention will be examined. A control group will start with the intervention after a waiting period of 6 months.

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Brief Summary in Scientific Language

In a pilot study, we have shown that physical training on a regular basis has a significant positive influence on the cardio vascular system in men between 45 and 65 years. Aim of the study is to show that a six month physical training intervention leads to an improvement on telomere length and elevates the peak oxygen consumption in a cohort of 313 female volunteers with a mainly sedentary way of working. Further the influence of chonical inflammation (paradontal status) and the hormonal balance (post menopause) on the training intervention will be examined. A control group will start with the intervention after a waiting period of 6 months.

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Organizational Data

  •   DRKS00005159
  •   2013/09/25
  •   [---]*
  •   yes
  •   Approved
  •   6428, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Healthy female volunteers
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Interventions/Observational Groups

  •   Training intervention of 210 min per week over a period of 6 months. Training could be bicycling, ergometer training, swimming, walking, nordic-walking, jogging, running, rowing-ergometer, shoulder-arm-ergometer. Also daily activities will be relevant as physical activities.
  •   Waiting-control group of half of the study participants.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Differences in telomere length in mononuclear cells (cells will be drwan from venous blood) between baseline and after 6 months intervention. Peak oxygen consumption (VO2peak) at baseline and after 6 months.

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Secondary Outcome

Measurements from venous blood:
Oxidative stress (malondialdehyd, nitrate, nirtite), OxLDL, sodium, potassium, calcium, magnesium, phosphate, glucose, bilirubin, creatinine (eGFR), urea, urea acid, cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, creatinkinase, Gamma-GT, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, ferritin, hs CRP, cystatine C, transferrinrezeptor, TSH, NTproBNP, LH, FSH, estradiol, progesterone, ex vivo stimulationtest TFNalpha.
Additionally, for later analyses of new or newly relevant parameters/biomarkers aliquots will be stored in the unified biobank hannover.
Measurements from arterialized capillary blood: lactate, glucose.
Measurement from Saliva: ROS.
Questionnaires:
WorkAbilityIndex, SF36, nutrition analyses
Other Measurements: systolic and diastolic blood pressure
Each measurement will be done at baseline and after 6 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/11/20
  •   313
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   45   Years
  •   65   Years
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Additional Inclusion Criteria

Females (45 - 65 years old) with a mainly sedentary way of work and no physical activity during leisure time.

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Exclusion Criteria

- smoker -diabetes mellitus - operations during the last 8 weeks - artificial joint replacement less then 6 months before the start of the study - coronary/arterial disease - not medicamentous adequately treated hypertension - cancer - other diseases that interfere with physical activity.

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Addresses

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    • MHH - HTTG Chirurgie
    • Mr.  Prof.  Axel  Haverich 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr.  Uwe  Tegtbur 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Julian  Eigendorf 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Rebirth Exzellenzcluster, MHH
    • Calrl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    •   [---]*
    •   [---]*
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    • Deutsche Herzstiftung
    • Vogtstraß 50
    • 60322  Frankfurt
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/26
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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.