CClinicalTrials.gg
CompletedNCT03282682Updated Jul 30, 2021Results posted

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

An interventional study of Strength training in Hypogonadism, Male, Physical Activity and Testosterone Deficiency, sponsored by Comenius University. Completed at 1 site in Slovakia. Open to male participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-30.

Sponsored by Comenius University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
45 Years to 60 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypogonadism, Male
  • Physical Activity
  • Testosterone Deficiency

Keywords

  • hypogonadism
  • aging male
  • strength training
  • physical activity
  • testosterone
03

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    hypogonadal males without TRT

    Strength training

    Procedure: Strength training

  • Experimental
    hypogonadal males with TRT

    Strength training and regular prescribed testosterone therapy given by participant urologist.

    Procedure: Strength training

  • Active comparator
    healthy eugonadal males

    Strength training

    Procedure: Strength training

Interventions

  • ProcedureStrength 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.

05

What researchers measure

Primary outcomes

  1. Change From Baseline in Lean Mass

    Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

    Time frame: 7 days before intervention, 7 days after intervention

Secondary outcomes

  1. Change From Baseline in Fat Mass

    Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

    Time frame: 7 days before intervention, 7 days after intervention

  2. Change From Baseline in Total Body Mass

    Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

    Time frame: 7 days before intervention, 7 days after intervention

  3. Change From Baseline in 10-m Usual Walk Test

    Measured in seconds by Microgates Photocells and than calculated to meters per second.

    Time frame: 7 days before intervention, 7 days after intervention

  4. Change From Baseline in 10-m Fast Walk Test

    Measured in seconds by Microgates Photocells than calculated to meters per second

    Time frame: 7 days before intervention, 7 days after intervention

  5. Change From Baseline in Handgrip Strength

    Measured by Camry Digital Hand Dynamometer.

    Time frame: 7 days before intervention, 7 days after intervention

  6. Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension

    Measured by Portable Isometric Knee Dynamometer.

    Time frame: 7 days before intervention, 7 days after intervention

  7. Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion

    Measured by Portable Isometric Knee Dynamometer.

    Time frame: 7 days before intervention, 7 days after intervention

  8. Change From Baseline in The Single Stage Treadmill Walking Test

    This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.

    Time frame: 7 days before intervention, 7 days after intervention

  9. Change From Baseline in Predicted One Repetition Maximum on Leg Press

    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.

    Time frame: 7 days before intervention, 7 days after intervention

  10. Change From Baseline in Maximal Voluntary Contraction in Benchpress

    Measured in N by FiTRO Force Plates.

    Time frame: 7 days before intervention, 7 days after intervention

  11. Change From Baseline in The Short Form Health Survey (SF-36)

    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.

    Time frame: 7 days before intervention, 7 days after intervention

  12. Change From Baseline in Aging Males' Symptom (AMS) Scale

    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.

    Time frame: 7 days before intervention, 7 days after intervention

  13. Change From Baseline in Metabolic Parameters

    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.

    Time frame: 7 days before intervention, 7 days after intervention

  14. Change From Baseline in Liver Function Blood Parameters

    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.

    Time frame: 7 days before intervention, 14 days after intervention

  15. Change From Baseline in Hormonal Parameters

    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.

    Time frame: 7 days before intervention, 14 days after intervention

  16. Change From Baseline in Ions

    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.

    Time frame: 7 days before intervention, 14 days after intervention

  17. Change From Baseline in CRP

    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.

    Time frame: 7 days before intervention, 14 days after intervention

  18. Change From Baseline in Muscle Fiber Size

    Muscle fiber size measured in um2. Analysis of the date are in progress.

    Time frame: 7 days before intervention, 14 days after intervention

  19. Change From Baseline in Regulators of Muscle Fiber Size

    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.

    Time frame: 7 days before intervention, 14 days after intervention

06

Results

Posted May 5, 2020
Limitations and caveats
The major limit of the study was low number of the newly diagnosed patients.

Participant flow

Participant flow — Overall Study
MilestoneHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Started688
Completed688
Not completed000

Outcome measures

PrimaryChange From Baseline in Lean Mass

Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · grams
Change From Baseline in Lean Mass
gramsHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Lean Mass2734 ± 1967499 ± 15662268 ± 2609
SecondaryChange From Baseline in Fat Mass

Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · grams
Change From Baseline in Fat Mass
gramsHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Fat Mass-1969 ± 2526-1263 ± 1920-755 ± 1514
SecondaryChange From Baseline in Total Body Mass

Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · grams
Change From Baseline in Total Body Mass
gramsHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Total Body Mass621.53 ± 2922.45-821.73 ± 3279.291435.04 ± 3655.01
SecondaryChange From Baseline in 10-m Usual Walk Test

Measured in seconds by Microgates Photocells and than calculated to meters per second.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · m/s
Change From Baseline in 10-m Usual Walk Test
m/sHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in 10-m Usual Walk Test0 ± 0.089-0.06 ± 0.146-0.05 ± 0.136
SecondaryChange From Baseline in 10-m Fast Walk Test

Measured in seconds by Microgates Photocells than calculated to meters per second

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · m/s
Change From Baseline in 10-m Fast Walk Test
m/sHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in 10-m Fast Walk Test0.05 ± 0.255-0.1 ± 0.172-0.13 ± 0.253
SecondaryChange From Baseline in Handgrip Strength

Measured by Camry Digital Hand Dynamometer.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · kg
Change From Baseline in Handgrip Strength
kgHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Handgrip Strength-1.41 ± 4.000.84 ± 2.12-0.02 ± 3.28
SecondaryChange From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension

Measured by Portable Isometric Knee Dynamometer.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · Nm
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension
NmHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension-9.65 ± 93.448.15 ± 28.971.35 ± 69.50
SecondaryChange From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion

Measured by Portable Isometric Knee Dynamometer.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · Nm
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion
NmHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion2.32 ± 27.8924.64 ± 36.0914.36 ± 28.13
SecondaryChange From Baseline in The Single Stage Treadmill Walking Test

This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · ml.kg-1.min-1
Change From Baseline in The Single Stage Treadmill Walking Test
ml.kg-1.min-1Hypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in The Single Stage Treadmill Walking Test0.61 ± 0.640.25 ± 0.640.42 ± 0.54
SecondaryChange From Baseline in Predicted One Repetition Maximum on Leg Press

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.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · kg
Change From Baseline in Predicted One Repetition Maximum on Leg Press
kgHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Predicted One Repetition Maximum on Leg Press45.31 ± 28.3951.59 ± 34.4351.40 ± 27.16
SecondaryChange From Baseline in Maximal Voluntary Contraction in Benchpress

Measured in N by FiTRO Force Plates.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · N
Change From Baseline in Maximal Voluntary Contraction in Benchpress
NHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Maximal Voluntary Contraction in Benchpress-6.49 ± 147.1264.31 ± 143.2966.68 ± 103.38
SecondaryChange From Baseline in The Short Form Health Survey (SF-36)

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.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · score on a scale
Change From Baseline in The Short Form Health Survey (SF-36)
score on a scaleHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in The Short Form Health Survey (SF-36)2.50 ± 9.877.50 ± 18.523.75 ± 12.46
SecondaryChange From Baseline in Aging Males' Symptom (AMS) Scale

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.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · score on a scale
Change From Baseline in Aging Males' Symptom (AMS) Scale
score on a scaleHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in Aging Males' Symptom (AMS) Scale-4.83 ± 7.41-2.00 ± 5.98-6.25 ± 5.09
SecondaryChange From Baseline in Metabolic Parameters

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.

Time frame:
7 days before intervention, 7 days after intervention
Reported as:
Mean · mmol/l
Change From Baseline in Metabolic Parameters
mmol/lHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
S-Bilirubin0.0006 ± 0.00380.0008 ± 0.004-0.003 ± 0.006
S-Creatinine-0.006 ± 0.008-0.0002 ± 0.00520.0011 ± 0.0038
S-Glucose0.33 ± 0.440.29 ± 0.50-0.02 ± 0.65
S-Total Cholesterol0.10 ± 0.670.22 ± 0.710.29 ± 1.11
S-HDL Cholesterol0.06 ± 0.100.09 ± 0.170.08 ± 0.20
S-LDL Cholesterol-0.06 ± 0.52-0.30 ± 1.07-0.12 ± 0.84
S-Triglyceride-0.20 ± 0.460.38 ± 1.270.28 ± 0.86
S-Urea-0.16 ± 1.453.77 ± 8.580.84 ± 1.26
S-Uric Acid-0.016 ± 0.0710.004 ± 0.047-0.010 ± 0.053
SecondaryChange From Baseline in Liver Function Blood Parameters

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.

Time frame:
7 days before intervention, 14 days after intervention
Reported as:
Mean · µkat/l
Change From Baseline in Liver Function Blood Parameters
µkat/lHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
S-ALP0.06 ± 0.110.05 ± 0.110.10 ± 0.18
S-ALT0.19 ± 0.49-0.05 ± 0.28-0.07 ± 0.10
S-AMS0.06 ± 0.230.05 ± 0.080.07 ± 0.16
S-AST0.05 ± 0.190.00 ± 0.19-0.01 ± 0.04
S-GMT-0.13 ± 0.230.01 ± 0.16-0.05 ± 0.27
SecondaryChange From Baseline in Hormonal Parameters

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.

Time frame:
7 days before intervention, 14 days after intervention
Reported as:
Mean · nmol/l
Change From Baseline in Hormonal Parameters
nmol/lHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
S-Testosterone1.69 ± 1.20-0.50 ± 3.51-1.99 ± 2.59
S-SHBG2.42 ± 4.67-1.35 ± 6.10-2.93 ± 6.55
S-Cortisol-32.93 ± 103.28-44.60 ± 140.8334.34 ± 159.29
S-Insuline0.004 ± 0.0460.019 ± 0.0610.006 ± 0.023
SecondaryChange From Baseline in Ions

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.

Time frame:
7 days before intervention, 14 days after intervention
Reported as:
Mean · mmol/l
Change From Baseline in Ions
mmol/lHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
S-Chlorides-1.47 ± 2.50-0.77 ± 4.21-0.33 ± 3.78
S-Potassium0.17 ± 0.340.06 ± 0.130.14 ± 0.31
S-Sodium0.08 ± 1.26-0.15 ± 1.31-0.19 ± 1.13
SecondaryChange From Baseline in CRP

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.

Time frame:
7 days before intervention, 14 days after intervention
Reported as:
Mean · mg/l
Change From Baseline in CRP
mg/lHypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal Males
Change From Baseline in CRP0.02 ± 9.400.13 ± 2.26-1.67 ± 2.40
SecondaryChange From Baseline in Muscle Fiber Size

Muscle fiber size measured in um2. Analysis of the date are in progress.

Time frame:
7 days before intervention, 14 days after intervention

Results for this outcome have not been posted.

SecondaryChange From Baseline in Regulators of Muscle Fiber Size

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.

Time frame:
7 days before intervention, 14 days after intervention

Results for this outcome have not been posted.

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hypogonadal Males Without TRT0/6 (0%)0/6 (0%)0/6 (0%)
Hypogonadal Males With TRT0/8 (0%)0/8 (0%)0/8 (0%)
Healthy Eugonadal Males0/8 (0%)0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Hypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal MalesTotal
Mean48.41 ± 7.943.03 ± 2.950.11 ± 5.147.07 ± 7.15
Sex: Female, Male
Sex: Female, Male(Participants)Hypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal MalesTotal
Female0000
Male68822
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Hypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal MalesTotal
Slovak68822
Region of Enrollment
Region of Enrollment(participants)Hypogonadal Males Without TRTHypogonadal Males With TRTHealthy Eugonadal MalesTotal
Slovakia68822
07

Study locations

1 site
  • Comenius University in Bratislava, Faculty of physical education and sport
    Bratislava, 814 69, Slovakia
08

References and documents

Publications

  • Basaria S. Androgen deprivation therapy, insulin resistance, and cardiovascular mortality: an inconvenient truth. J Androl. 2008 Sep-Oct;29(5):534-9. doi: 10.2164/jandrol.108.005454. Epub 2008 Jun 20. PubMed 18567642 ↗
  • Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress ME, Ballard R, Schwartz RS. Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels. J Clin Endocrinol Metab. 2013 May;98(5):1891-900. doi: 10.1210/jc.2013-2227. Epub 2013 Mar 26. PubMed 23533227 ↗
  • Schwarz ER, Willix RD Jr. Impact of a physician-supervised exercise-nutrition program with testosterone substitution in partial androgen-deficient middle-aged obese men. J Geriatr Cardiol. 2011 Dec;8(4):201-6. doi: 10.3724/SP.J.1263.2011.00201. PubMed 22783306 ↗
  • Kadi F, Bonnerud P, Eriksson A, Thornell LE. The expression of androgen receptors in human neck and limb muscles: effects of training and self-administration of androgenic-anabolic steroids. Histochem Cell Biol. 2000 Jan;113(1):25-9. doi: 10.1007/s004180050003. PubMed 10664066 ↗
  • Gardner JR, Livingston PM, Fraser SF. Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. J Clin Oncol. 2014 Feb 1;32(4):335-46. doi: 10.1200/JCO.2013.49.5523. Epub 2013 Dec 16. PubMed 24344218 ↗
  • Kralik M, Cvecka J, Buzgo G, Putala M, Ukropcova B, Ukropec J, Killinger Z, Payer J, Kollarik B, Bujdak P, Raastad T, Sedliak M. Strength training as a supplemental therapy for androgen deficiency of the aging male (ADAM): study protocol for a three-arm clinical trial. BMJ Open. 2019 Sep 5;9(9):e025991. doi: 10.1136/bmjopen-2018-025991. PubMed 31492775 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 23, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Registry details

Key details

Study ID
NCT03282682
Lead sponsor
Comenius University
Collaborators
Norwegian School of Sport Sciences, Slovak Academy of Sciences
Responsible party
Milan Sedliak (Independent researcher, Vice-dean for science, research and international cooperation, Comenius University) — Principal investigator
First posted
Sep 14, 2017
Start date
Oct 1, 2017
Primary completion
May 30, 2019
Completion
May 30, 2019
Results posted
May 5, 2020
Last update
Jul 30, 2021

Study contacts

Milan Sedliak, assoc. prof.
principal investigator · Comenius University of Bratislava, Faculty Physical Education and Sport

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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