Trial document
DRKS00005159
Trial Description
Title
Improvement of endogenous regeneration in female healthy volunteers through physical exercise “REBIRTH aktiv women”
Trial Acronym
Rebirth women
URL of the Trial
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.
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.
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00005159
- 2013/09/25
- [---]*
- yes
- Approved
- 6428, Ethikkommission der Medizinischen Hochschule Hannover
Secondary IDs
- [---]*
Health Condition or Problem studied
- Healthy female volunteers
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.
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Open (masking not used)
- [---]*
- Control group receives no treatment
- Prevention
- Parallel
- N/A
- N/A
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.
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.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2013/11/20
- 313
- Monocenter trial
- National
Inclusion Criteria
- Female
- 45 Years
- 65 Years
Additional Inclusion Criteria
Females (45 - 65 years old) with a mainly sedentary way of work and no physical activity during leisure time.
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.
Addresses
-
start of 1:1-Block address primary-sponsor
- MHH - HTTG Chirurgie
- Mr. Prof. Axel Haverich
- Carl-Neuberg-Str. 1
- 30625 Hannover
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Medizinische Hochschule Hannover
- Mr. Prof. Dr. Uwe Tegtbur
- Carl-Neuberg-Str. 1
- 30625 Hannover
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0511 532 9216
- [---]*
- tegtbur.uwe at mh-hannover.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Medizinische Hochschule Hannover
- Mr. Julian Eigendorf
- Carl-Neuberg-Str. 1
- 30625 Hannover
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0511 532 9216
- [---]*
- eigendorf.julian at mh-hannover.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Rebirth Exzellenzcluster, MHH
- Calrl-Neuberg-Str. 1
- 30625 Hannover
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport -
start of 1:1-Block address otherSupport
- Deutsche Herzstiftung
- Vogtstraß 50
- 60322 Frankfurt
- Germany
end of 1:1-Block address otherSupportstart of 1:1-Block address contact otherSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact otherSupport
Status
- Recruiting complete, follow-up complete
- 2015/03/26
Trial Publications, Results and other Documents
- [---]*