Trial document




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  DRKS00017635

Trial Description

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Title

Football training program vs. Doctor-Based Recommendations for Healthy Lifestyle - Comparative Study to Improve the Risk Factors for Heart, Circulatory and Dementia - Fit and Fun with Football

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Trial Acronym

Fit and Fun with Football: The 3 F Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Thesis:
Age-adapted football training programs can lower blood pressure in hypertensive individuals.

Introduction:
Various studies suggest that playing football is very effective in improving classic risk factors such as arterial hypertension, diabetes and obesity, as well as improving the bone and muscle stability of older people. However, the data situation is problematic. Many of the publications are based on small, mostly uncontrolled trials without control groups. In addition, data from Germany are almost completely missing.

Study Procedure:
Hypertensive men between the ages of 45-70 years with hypertension are included.
The study will be conducted as a prospective intervention study.
The survey starts on 15.07.2019. It is planned to include a total of 200 people.
Participation in the study takes place on a voluntary basis after the consent of the participants in the data collection and storage as well as after a successful basic medical examination.
The participants are monitored for a period of one year, with half of the participants taking part in a structured football training program after learning about their personal risk prevention, the other half receiving a written recommendation for their individual risk prevention based on their medical examination results.
The primary study objective is to improve blood pressure in 24-hour blood pressure measurement (ABPM) and / or to reduce the number / dose of antihypertensive drugs.
Secondary study objective is the improvement of other vascular risk factors (diab. mell., smoking, overweight, lipid metabolism disorders, occupational stress).

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Brief Summary in Scientific Language

Thesis:
Age-adapted football training programs can lower blood pressure in hypertensive individuals.

Introduction:
Various studies suggest that playing football is very effective in improving classic risk factors such as arterial hypertension, diabetes and obesity, as well as improving the bone and muscle stability of older people. However, the data situation is problematic. Many of the publications are based on small, mostly uncontrolled trials without control groups. In addition, data from Germany are almost completely missing.

Study Procedure:
Hypertensive men between the ages of 45-70 years with hypertension are included.
The study will be conducted as a prospective intervention study.
The survey starts on 15.07.2019. It is planned to include a total of 200 people.
Participation in the study takes place on a voluntary basis after the consent of the participants in the data collection and storage as well as after a successful basic medical examination.
The participants are monitored for a period of one year, with half of the participants taking part in a structured football training program after learning about their personal risk prevention, the other half receiving a written recommendation for their individual risk prevention based on their medical examination results.
The primary study objective is to improve blood pressure in 24-hour blood pressure measurement (ABPM) and / or to reduce the number / dose of antihypertensive drugs.
Secondary study objective is the improvement of other vascular risk factors (diab. mell., smoking, overweight, lipid metabolism disorders, occupational stress).

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Organizational Data

  •   DRKS00017635
  •   2019/07/30
  •   [---]*
  •   yes
  •   Approved
  •   27/6/19, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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

  •   I10.0 -  [generalization I10: Essential (primary) hypertension]
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Interventions/Observational Groups

  •   Structured football training program
  •   Written recommendation for individual risk prevention
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Characteristics

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

Improvement of blood pressure in 24h blood pressure measurement (ABDM) and / or reduction of number / dosage of antihypertensives.

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Secondary Outcome

After 12 months
• Mean day and night blood pressure (ABPM)
• Office blood pressure
• Blood pressure during self-measurements
• heart rate (day, night, variability)
• blood pressure variability (ABPM)
• Central blood pressure
• lipid metabolism parameters
• Glucose, HbA1c
• Body Mass Index
• Nutrition
• Well-being Scale
• stress questionnaire
• Physical activity
• DemTect

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   Actual
  •   2019/07/15
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   45   Years
  •   70   Years
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Additional Inclusion Criteria

• ≥ 45 years <= 70 years who have not practiced sport regularly for 5 years
• Arterial hypertension (treated, untreated)
• The diagnosis must be confirmed by a standardized blood pressure measurement (3 measurements after 5 minutes of sitting quietly) or documented by findings of the general practitioner
• Initial medical examinations to play football passed
• Before signing the survey, the signed declaration of consent must be present

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Exclusion Criteria

• Age <45 years or> 70 years
• No assured arterial hypertension
• Lack of medical fitness
• Missing consent

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Addresses

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    • Deutscher Fußball-Bund (DFB), Deutscher Fußball-Bund e.V. (DFB)Hermann-Neuberger-Haus
    • Mr.  Eugen  Gehlenborg 
    • Otto-Fleck-Schneise 6
    • 60528   Frankfurt/Main
    • Germany
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    • St. Josefs-Hospital
    • Mr.  Prof. Dr.  Joachim  Schrader 
    • Krankenhausstr. 13
    • 49661  Cloppenburg
    • Germany
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    • St. Josefs-Hospital
    • Ms.  Sandra  Garstecki 
    • Krankenhausstr. 13
    • 49661  Cloppenburg
    • Germany
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Sources of Monetary or Material Support

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    • Landkreis Cloppenburg
    • 49661  Cloppenburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • St. Josefs-Hospital
    • Mr.  Prof. Dr.  Joachim  Schrader 
    • Krankenhausstr. 13
    • 49661  Cloppenburg
    • Germany
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    end of 1:1-Block address contact otherSupport
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Status

  •   Recruiting ongoing
  •   [---]*
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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.