Strength training as a supplemental therapy for androgen deficiency of the aging male (ADAM): study protocol for a three-arm clinical trial.

Androgen deficiency of the ageing male is a clinical syndrome resulting from the low production of androgens (testosterone levels <6.9 nmol/L) with symptoms including decline in lean mass, muscle strength, increases in body mass and overall fat mass. The aim of the study is to examine the effect of a 12 week strength training intervention on body composition, physical function, muscle cellular and molecular and selected biochemical markers of metabolic health in hypogonadal patients.

The study is three-group controlled 12-week experiment to assess the effect of strength training on hypogonadal patients with testosterone replacement therapy and newly diagnosed males without testosterone replacement therapy. Age matched healthy eugonadal males are also engaged in strength training. Lean mass is used to determine sample size indicating, that 22 subjects per group will be sufficient to detect intervention related changes at the power of 0.90. All outcomes are collected before the intervention (pre-intervention assessments) and after the intervention (post-intervention assessments). Clinical outcomes are body composition (lean mass, fat mass and total body mass) measured by dual-energy X-ray absorptiometry, physical functioning assessed by physical tests and psychosocial functioning. The most important haematological and biochemical parameters included are glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, testosterone, luteinizing hormone, follicle-stimulating hormone, sexhormone-binding globulin, insulin and prostate-specific antigen. Muscle cellular and molecular outcomes are muscle fibre size and regulators of muscle fibre size. Muscle cellular outcomes are measured from muscle biopsies obtained from musculus vastus lateralis.

This trial is approved by Ethics Committee of the University Hospital in Bratislava, Slovakia, (ref. trial number: 127/2017) and all subjects will be fully informed on the rationale, risks and benefits of the study and sign the written informed consent prior to entering the study. Results will be published in peer-reviewed journals and presented in scientific conferences.

NCT03282682.

BMJ open. 2019 Sep 05*** epublish ***

Michal Kralik, Jan Cvecka, Gabriel Buzgo, Matus Putala, Barbara Ukropcova, Jozef Ukropec, Zdenko Killinger, Juraj Payer, Boris Kollarik, Peter Bujdak, Truls Raastad, Milan Sedliak

Deparment of Biological and Medical Sciences, Faculty of Physical Education and Sports, Comenius University in Bratislava, Bratislava, Slovakia., Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia., 5th Department of Internal Medicine, Faculty of Medicine, Comenius University in Bratislava, University Hospital, Bratislava, Slovakia., Department of Urology, University Hospital - Petrzalka, Bratislava, Slovakia., Department of Urology, Slovak Medical University Bratislava, Bratislava, Slovakia., Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway., Deparment of Biological and Medical Sciences, Faculty of Physical Education and Sports, Comenius University in Bratislava, Bratislava, Slovakia .

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