Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male
Condition: Hypogonadism, Male; Physical Activity; Testosterone Deficiency
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional

Summary: 
      This study examines the effect of 12-week strength training program with and without
      testosterone replacement therapy (TRT) on body composition, physical function, selected
      biochemical markers of metabolic health, molecular parameters of training adaptation and the
      quality of life patients with ADAM. The investigators believe, that strength training program
      performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and
      gain lean mass), muscle strength, muscle power and general quality of life in all training
      groups. In addition, combination TRT and strength training could help decrease fat mass,
      improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for
      hypogonadal ageing males.
    

Detailed description: 
      The study is 3 groups controlled 12-week study to assess the effect of testosterone
      replacement therapy (TRT) with strength training (ST) and strength training (ST) for
      hypogonadal participants without testosterone replacement therapy (NON-TRT) with control
      healthy eugonadal group, that is also engaged in strength training.

      Strength training protocol starts one week after all the pre-intervention testing. The
      intervention is performed at the Comenius University in Bratislava, Faculty of Physical
      Education and Sport (FSPORT CU) in Slovakia. The strength training protocol follows a
      modified resistance exercise program. The participants perform strength training sessions two
      times per week for 12 weeks. All training sessions are supervised and guided by professional
      coaches with university degree in sports training to ensure safety, technique and progression
      in training load, with a maximum of three participants per coach.

      Each training session include 5-minute general dynamic warm-up followed by progressive
      strength training with exercises for the entire body. The strength exercises are performed
      with free weights and on machines. The training program consist of 6 exercises for upper and
      lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in
      eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes.
      The participants are instructed to perform concentric action in 2 s and immediately after
      eccentric action in also 2 s. The exercises performed are: leg press, split squats, bench
      press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell
      bench press, incline dumbbell bench press. Training equipment is provided by KOHI Leopoldov,
      Slovakia and Technogym, Italia.

      Clinical and muscle cellular outcomes are collected before the intervention (pre-testing
      assessments) and after the intervention (post-testing assessments). Post intervention
      measurements start 7 days after intervention and go up to 3 weeks after intervention.

      Clinical outcomes Body composition analysis is measured by Dual-energy X-ray Absorptiometry
      using Hologic fan-beam bone densitometer Discovery QDR series. LBM(lean body mass) is
      measured in total body and separately for arms, legs and trunk. The changes in lower and
      upper body LBM are investigated separately because of differences in androgen sensitivity in
      leg muscles compared to neck, chest and shoulder muscles. Body weight is measured by
      bioimpedance scale, the height by stadiometer and waist circumference by tape. The body mass
      index is calculated.

      Biochemical outcomes Fasting morning venous blood is taken from 8:00 am to 10:00 am. The
      haematological and biochemical parameters analysed are Haemoglobin, hematocrits, leucocytes,
      thrombocytes, glucose, urea, sodium, potassium, calcium, ALAT, total cholesterol, LDL
      cholesterol, HDL cholesterol, triglyceride, testosterone, oestrogen, LH, FSH, SHBG, albumin,
      bilirubin, total protein, CRP, insulin, PSA.

      Physical functioning Muscle strength is measured by novel portable isometric knee dynamometer
      (maximal voluntary contraction of isometric knee extension, isometric knee flexion), hand
      grip strength dynamometry by Camry Digital Hand Dynamometer, predicted 1RM leg press from
      multiple repetition maximum testing. Cardio-respiratory fitness is measured by The Single
      Stage Treadmill Walking Test on Woodway Pro Treadmill, 10-m fast walk and 10-m usual walk
      measured by Photocells.

      Quality of life The general health status is measured by The Short Form (36) Health Survey
      patient-reported survey of patient health (SF-36). In addition to that clinically
      investigating the health-related quality of life (HRQoL) and symptoms of aging men are
      measured by Aging Males' Symptom Scale (AMS).

      Muscle cellular outcomes Muscle biopsies are obtain from approximately 80% of the subjects
      included in the study. Participants not willing to undergo biopsy are still eligible for
      trial participation.

      With the participant in a supine position, a 5 mm Muscle Biopsy Cannula (Bergstrom-stille,
      Sweden) with manual suction is used to obtain muscle samples (200 mg), under local
      anaesthesia (Lidocain 2%,). Before the intervention the biopsy is obtained from the
      mid-section of the right musculus vastus lateralis, and after the intervention the biopsy is
      obtained 3 cm proximal to the pre-intervention biopsy.
    

Intervention name(s): Strength training
Intervention type(s): Procedure
Intervention description(s): The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is 3 arms 12-week strength training program to assess the effect of testosterone replacement therapy (TRT) with strength training (ST) and strength training (ST) for hypogonadal patients without testosterone replacement therapy (NON-TRT) with control healthy eugonadal group, that is also engaged in strength training.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: hypogonadism; aging male; strength training; physical activity; testosterone