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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282682
Recruitment Status : Completed
First Posted : September 14, 2017
Results First Posted : May 5, 2020
Last Update Posted : May 5, 2020
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 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
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 2019

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. Change From Baseline in Lean Mass [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.


Secondary Outcome Measures :
  1. Change From Baseline in Fat Mass [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

  2. Change From Baseline in Total Body Mass [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

  3. Change From Baseline in 10-m Usual Walk Test [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Measured in seconds by Microgates Photocells and than calculated to meters per second.

  4. Change From Baseline in 10-m Fast Walk Test [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Measured in seconds by Microgates Photocells than calculated to meters per second

  5. Change From Baseline in Handgrip Strength [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Measured by Camry Digital Hand Dynamometer.

  6. Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Measured by Portable Isometric Knee Dynamometer.

  7. Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Measured by Portable Isometric Knee Dynamometer.

  8. Change From Baseline in The Single Stage Treadmill Walking Test [ Time Frame: 7 days before intervention, 7 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 From Baseline in Predicted One Repetition Maximum on Leg Press [ Time Frame: 7 days before intervention, 7 days after intervention ]
    One repetition maximum in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine.

  10. Change From Baseline in Maximal Voluntary Contraction in Benchpress [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Measured in N by FiTRO Force Plates.

  11. Change From Baseline in The Short Form Health Survey (SF-36) [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score.

  12. Change From Baseline in Aging Males' Symptom (AMS) Scale [ Time Frame: 7 days before intervention, 7 days after intervention ]

    Measuring symptoms of ageing men by numeric score scale.

    The questionnaire has for each of the 17 item an option to check one of 5 degrees of severity (severity 1...5 points at the questionnaire).

    The composite scores for each of the three dimensions (sub-scales) is based on adding up the scores of the items of the respective dimensions. The composite score (total score) is the sum of the three dimension scores. Higher score means higher severity of symptoms. The minimum total score is 17 and the maximum is 85.


  13. Change From Baseline in Metabolic Parameters [ Time Frame: 7 days before intervention, 7 days after intervention ]
    Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.

  14. Change From Baseline in Liver Function Blood Parameters [ Time Frame: 7 days before intervention, 14 days after intervention ]
    Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.

  15. Change From Baseline in Hormonal Parameters [ Time Frame: 7 days before intervention, 14 days after intervention ]
    Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.

  16. Change From Baseline in Ions [ Time Frame: 7 days before intervention, 14 days after intervention ]
    Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.

  17. Change From Baseline in CRP [ Time Frame: 7 days before intervention, 14 days after intervention ]
    Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.

  18. Change From Baseline in Muscle Fiber Size [ Time Frame: 7 days before intervention, 14 days after intervention ]
    Muscle fiber size measured in um2. Analysis of the date are in progress.

  19. Change From Baseline in Regulators of Muscle Fiber Size [ Time Frame: 7 days before intervention, 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. Analysis of the date are in progress.



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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


Locations
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Slovakia
Comenius University in Bratislava, Faculty of physical education and sport
Bratislava, Slovakia, 814 69
Sponsors and Collaborators
Comenius University
Norwegian School of Sport Sciences
Slovak Academy of Sciences
Investigators
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Principal Investigator: Milan Sedliak, PhD. Comenius University of Bratislava, Faculty Physical Education and Sport
  Study Documents (Full-Text)

Documents provided by Milan Sedliak, Comenius University:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Milan Sedliak, Independent researcher, Vice-dean for science, research and international cooperation, Comenius University
ClinicalTrials.gov Identifier: NCT03282682    
Other Study ID Numbers: FSPORT-CU-ADAM
First Posted: September 14, 2017    Key Record Dates
Results First Posted: May 5, 2020
Last Update Posted: May 5, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Hypogonadism
Eunuchism
Gonadal Disorders
Endocrine System Diseases