Trial document





This trial has been registered retrospectively.
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  DRKS00015080

Trial Description

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Title

Blood flow restriction cycling enhances post exercise hypotension in hypertensive subjects – a randomized controlled trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

To enhance the medical sports therapy of high blood pressure, the acute circulatory effects of 15 minute cycle training with restriction of venous blood flow should be compared with a common 45 minute bicycle training at the same intensity. Medicated subjects with diagnosed hypertension will take one of the two protocols after an initial test. The previously measured resting blood pressure is compared with the pressure recorded after training, whereby the largest pressure drop in the first 30 minutes after exercise representing measurement for statistical evaluation. It is suspected that the muscles send a strong signal via the declining nerves to the circulatory regulating brain region during 15 minutes of training, so that the drop in blood pressure is greater compared to conventional training. This could provide the foundation for new training recommendations and further investigations.

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Brief Summary in Scientific Language

To enhance the medical sports therapy it is necessary to identify the type of training, which produces most post exercise hypotension (PEH) in hypertensive subjects. So research is aiming to compare an extensive (40%VO2Peak) 15 minute cycling blood flow restriction training (BFR) with a common 45 minute cycling training (END). Lowest blood pressure (BP) in the 30 minutes after exercise represents PEH and competed to resting blood pressure. BFR may lower BP more than END by enhancing the neuronal muscular feedback to the medullar part of the encephalon and depressing sympathetic output after exercise. Results may build strong foundation for further intervention trials and changes in sport recommendation for hypertensive subjects.

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Organizational Data

  •   DRKS00015080
  •   2018/07/12
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  •   yes
  •   Approved
  •   155/2017, Ethikkommission der Deutschen Sporthochschule in Köln
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Secondary IDs

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Health Condition or Problem studied

  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   15 min training on the bike ergometer at 40%VO2Peak with BFR-cuffs set at 70% of the occlusion pressure
  •   45 min training on the bike ergometer at 40%VO2Peak
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   I-II
  •   N/A
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Primary Outcome

VO2Peak is determined on the upright bike using the WHO protocol and a respiratory gas analysis.
Maximum heart rate is recorded during performance diagnistics via 12-channel-ECG.
Resting blood pressure and heart rate are measured with an automatic measuring device before training.
Occlusion pressure is determined via ultra sound.

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Secondary Outcome

Training heart rate, blood pressure, and resting heart rate measured up to 30 min after exercise

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/05/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   85   Years
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Additional Inclusion Criteria

diagnosed hypertension (essentiel), all medical settings, low to moderate fitness level

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Exclusion Criteria

Sportive restriction by treating physician, diabetes, abnomalities in resting- or stress-ECG according to Hollmann und Strüder

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Addresses

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    • Deutsche Sporthochschule Köln
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • DSHS, Institut für Kreislaufforschung und Sportmedizin
    • Mr.  Frederik  Eikens 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule in Köln
    • Mr.  Frederik  Eikens 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Kreislaufforschung und Sportmedzin, DSHS, Leiter Prof. Dr. HG Predel
    • 50933  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/06/13
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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.