Trial document




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  DRKS00017692

Trial Description

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Title

Pilot study: The acute influence of different intensities of strength training on the endocrine plasticity of the thyroid gland

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Trial Acronym

AIDISTEPT

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URL of the Trial

http:///

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Brief Summary in Lay Language

Due to the persisting symptoms of hypothyroidism despite hormone replacement, there is a great need to develop an alternative or complementary therapy. In order to develop a suitable sport therapeutic measure, the first step is to investigate the influence of different intensities of strength training on the concentrations of the thyroid hormones TSH, fT4 and fT3. In a pilot study healthy, premenopausal women will be recruited as suitable participants.

The participants take part in a total of two preliminary examinations and three measurements. In the measurements, the subjects complete four strength exercises (back squat, bench press, bent over row, shoulder press) with different load intensities (65%, 75% and 85% of the 1 Repetition Maximum). To determine the intensities, a maximum strength test for all exercises is carried out in the first pre-test. The remaining second preliminary examination serves to identify changes in thyroid hormones without training. In preparation for the examination, a two-week preparation phase takes place, during which the participants are instructed in the correct techniques of the exercises. In order to identify hormonal changes, the thyroid hormones TSH, fT4 and fT3 are recorded by blood samples taken before and after the training sessions on all measurements as well as during the second preliminary examination (no training).

The collected data will be used to determine the extent to which the different strength training intensities change the thyroid hormone concentrations.
It will also be tested whether higher intensities can be associated with lower hormone concentrations.

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Brief Summary in Scientific Language

Due to the persisting symptoms of hypothyroidism despite hormone replacement, there is a great need to develop an alternative or complementary therapy. In order to develop a suitable sport therapeutic measure, the first step is to investigate the influence of different intensities of strength training on the concentrations of the thyroid hormones TSH, fT4 and fT3. In a pilot study healthy, premenopausal women will be recruited as suitable participants.

The subjects take part in a total of two preliminary examinations and three measurements. In the measurements, the subjects complete four strength exercises (back squat, bench press, bent over row, shoulder press) with different load intensities (65%, 75% and 85% of the 1 RM). To determine the intensities, a maximum strength test for all exercises is carried out in the first pre-test. The remaining second preliminary examination serves to identify changes in thyroid hormones without training. In preparation for the examination, a two-week familiarization phase takes place, during which the participants are instructed in the correct techniques of the exercises. In order to identify hormonal changes, the thyroid hormones TSH, fT4 and fT3 are recorded by blood samples taken before and after the training sessions on all measurements as well as during the second preliminary examination (no training).

The collected data will be used to determine the extent to which the different strength training intensities change the thyroid hormone concentrations.
It will also be tested whether higher intensities can be associated with lower hormone concentrations.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017692
  •   2019/08/05
  •   [---]*
  •   yes
  •   Approved
  •   086/2019, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

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

  •   E03.8 -  Other specified hypothyroidism
  •   E03.9 -  Hypothyroidism, unspecified
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Interventions/Observational Groups

  •   The participants carry out a strength training with different intensities (65%, 75% and 85% of the 1 RM). Each subject completes a total of three trainings by performing the strength exercises back squat, bench press, bent over row and shoulder press. The intensities of the training sessions are performed in randomized order. In order to consider the circadian rhythm of the thyroid hormones, the measurements are always performed from 9 am to 10 am.

    In order to determine the training weights, the 1 RM of all exercises are determined in a pre-test.
  •   The subjects are their own control group. Prior to the measurements, the thyroid hormones TSH, fT4 and fT3 are recorded in a pre-test without training.

    9:00 a.m. blood collection - no training - 10:00 a.m. Blood collection
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Characteristics

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

The study ends if all subjects have completed the three measurements (training at 65%, 75% and 85% of the 1 repetition maximum) and the changes in thyroid hormones at the different intensities have been recorded.

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Secondary Outcome

not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/07/21
  •   6
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   30   Years
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Additional Inclusion Criteria

female, premenopausal (18-30 years), healthy, consistent menstrual cycle, at least 3 times physical activity per week

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Exclusion Criteria

BMI ≥ 30, hormone substitution (including. oral contraceptives), thyroid diseases, cardiac arrhythmias, metabolic diseases, cardiac insufficiency (EF <55), performance-limiting peripheral artery disease (Fontaine Stadium ≥ II), performance-limiting respiratory diseases, performance-limiting degenerative diseases, performance-limiting muscular diseases, performance-limiting kidney diseases, performance-limiting neurological diseases

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Addresses

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    • Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin
    • Mr.  Prof.  Patrick  Diel 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin
    • Mr.  Lars  Hanke 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin
    • Mr.  Lars  Hanke 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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