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Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male

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ClinicalTrials.gov Identifier: NCT03282682
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Norwegian School of Sport Sciences
Slovak Academy of Sciences
Information provided by (Responsible Party):
Milan Sedliak, Comenius University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypogonadism, Male Physical Activity Testosterone Deficiency Procedure: Strength training Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Official Title: Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male (ADAM)
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: hypogonadal males without TRT
Strength training
Procedure: Strength training
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.

Experimental: hypogonadal males with TRT
Strength training and regular prescribed testosterone therapy given by participant urologist.
Procedure: Strength training
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.

Active Comparator: healthy eugonadal males
Strength training
Procedure: Strength training
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.




Primary Outcome Measures :
  1. Body composition - Change in Lean Mass at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Separately in arms, legs, trunk and total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.Measured in g/m2.


Secondary Outcome Measures :
  1. Body composition - Change in Fat Mass at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Separately in arms, legs, trunk and total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.Measured in g/m2.

  2. Body composition - Change in Total Body Mass at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Separately in arms, legs, trunk and total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.Measured in g/m2.

  3. Change in 10-m Usual Walk Test at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Measured in seconds by Microgates Photocells

  4. Change in 10-m Fast Walk Test at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Measured in seconds by Microgates Photocells

  5. Change in Handgrip strength at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Measured in kg by Camry Digital Hand Dynamometer

  6. Change in maximal voluntary contraction (MVC) of isometric knee extension at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Measured in Nm by Novel Portable Isometric Knee Dynamometer.

  7. Change in maximal voluntary contraction (MVC) of isometric knee flexion at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Measured in Nm by Novel Portable Isometric Knee Dynamometer.

  8. Change in The Single Stage Treadmill Walking Test at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.

  9. Change in predicted one repetition maximum on Leg press at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    One repetition maximum(1RM) in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine.

  10. Change in maximal voluntary contraction (MVC) in benchpress at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Measured in N by FiTRO Force Plates.

  11. Change in The Short Form (36) Health Survey (SF36) at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL).

  12. Change in Aging Males' Symptom (AMS) Scale at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    Measuring symptoms of ageing men by numeric score scale.

  13. Change in biochemical parameters at 12 weeks [ Time Frame: 7-14 days before intervention, 7-10 days after intervention ]
    The haematological and biochemical parameters analysed are haemoglobin(g/l), hematocrits(ratio), leucocytes (10^9/l), thrombocytes (10^9/l), glucose (mmol/l), urea (mmol/l), sodium (mmol/l), potassium (mmol/l), calcium (mmol/l), ALAT, total cholesterol (mmol/l), LDL cholesterol (mmol/l), HDL cholesterol (mmol/l), triglyceride (mmol/l), testosterone (nmol/l), oestrogen (nmol/l), LH (nmol/l), FSH (nmol/l), SHBG (nmol/l), albumin (g/l), bilirubin (µmol/l), total protein (g/l), CRP(mg/l), insulin (mIU/l), PSA (ug/l).

  14. Muscle biopsy - Change in muscle fiber size at 12 weeks [ Time Frame: 7-14 days before intervention, 10-14 days after intervention ]
    Muscle fiber size measured in um2

  15. Muscle biopsy - Change in regulators of muscle fiber size at 12 weeks [ Time Frame: 7-14 days before intervention, 10-14 days after intervention ]
    Regulators of muscle fiber size - number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors, proteins involved in muscle hypertrophy



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of secondary hypogonadism on testosterone replacement therapy, newly diagnosed patients of secondary hypogonadism.

Exclusion Criteria:

  • Regular strength training, medical treating osteoporosis, abnormal digital rectal results, conditions which are medical contraindications (without adjusting state): diabetes mellitus, severe cardiac arrhythmia, uncontrolled hypertension, unstable angina pectoris, chronic obstructive pulmonary disease, epilepsy, unstable bone lesions with high risk of fracture, prostate cancer or abnormal serum PSA levels without adverse histological examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282682


Contacts
Contact: Michal Kralik, Magister +421 910272863 michal.kralik@uniba.sk

Locations
Slovakia
Comenius University in Bratislava, Faculty of physical education and sport Recruiting
Bratislava, Slovakia, 814 69
Contact: Michal Kralik    +421 910272863    michal.kralik@uniba.sk   
Sponsors and Collaborators
Comenius University
Norwegian School of Sport Sciences
Slovak Academy of Sciences
Investigators
Principal Investigator: Milan Sedliak, PhD. Comenius University of Bratislava, Faculty Physical Education and Sport

Publications of Results:
Responsible Party: Milan Sedliak, Independent researcher, Vice-dean for science, research and international cooperation, Comenius University
ClinicalTrials.gov Identifier: NCT03282682     History of Changes
Other Study ID Numbers: FSPORT-CU-ADAM
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Milan Sedliak, Comenius University:
hypogonadism
aging male
strength training
physical activity
testosterone

Additional relevant MeSH terms:
Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs