Hypogonadism, MaleNCT03282682
Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male
A study testing Strength training in people with Hypogonadism, Male and Physical Activity, run by Comenius University at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Male, Physical Activity, Testosterone Deficiency
- What is being tested?
- Strength training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Oct 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of secondary hypogonadism on testosterone replacement therapy, newly diagnosed patients of secondary hypogonadism.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
Comenius University in Bratislava, Faculty of physical education and sport
Bratislava, 814 69
About this study
Official title: Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male (ADAM)
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.
- Being tested
- Strength training
- Keywords
- hypogonadism, aging male, strength training, physical activity, testosterone
- Medical subject headings
- Eunuchism, Motor Activity, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| hypogonadal males without TRT | Experimental | Strength training Receives: Procedure: Strength training |
| hypogonadal males with TRT | Experimental | Strength training and regular prescribed testosterone therapy given by participant urologist. Receives: Procedure: Strength training |
| healthy eugonadal males | Active comparator | Strength training Receives: Procedure: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Lean Mass
Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
Measured: 7 days before intervention, 7 days after intervention
Secondary outcomes (19)
Change From Baseline in Fat Mass
Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
Measured: 7 days before intervention, 7 days after intervention
Change From Baseline in Total Body Mass
Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
Measured: 7 days before intervention, 7 days after intervention
Change From Baseline in 10-m Usual Walk Test
Measured in seconds by Microgates Photocells and than calculated to meters per second.
Measured: 7 days before intervention, 7 days after intervention
Change From Baseline in 10-m Fast Walk Test
Measured in seconds by Microgates Photocells than calculated to meters per second
Measured: 7 days before intervention, 7 days after intervention
Change From Baseline in Handgrip Strength
Measured by Camry Digital Hand Dynamometer.
Measured: 7 days before intervention, 7 days after intervention
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension
Measured by Portable Isometric Knee Dynamometer.
Measured: 7 days before intervention, 7 days after intervention
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion
Measured by Portable Isometric Knee Dynamometer.
Measured: 7 days before intervention, 7 days after intervention
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.
Measured: 7 days before intervention, 7 days after intervention
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.
Measured: 7 days before intervention, 7 days after intervention
Change From Baseline in Maximal Voluntary Contraction in Benchpress
Measured in N by FiTRO Force Plates.
Measured: 7 days before intervention, 7 days after intervention
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.
Measured: 7 days before intervention, 7 days after intervention
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.
Measured: 7 days before intervention, 7 days after intervention
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.
Measured: 7 days before intervention, 7 days after intervention
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.
Measured: 7 days before intervention, 14 days after intervention
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.
Measured: 7 days before intervention, 14 days after intervention
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.
Measured: 7 days before intervention, 14 days after intervention
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.
Measured: 7 days before intervention, 14 days after intervention
Change From Baseline in Muscle Fiber Size
Muscle fiber size measured in um2. Analysis of the date are in progress.
Measured: 7 days before intervention, 14 days after intervention
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.
Measured: 7 days before intervention, 14 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Oct 2017
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Slovak Academy of Sciences
- Responsible party
- Principal investigator, Milan Sedliak, Comenius University
- Investigators
- Milan Sedliak, assoc. prof., Principal investigator, Comenius University of Bratislava, Faculty Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282682
- Sponsor's protocol ID
- FSPORT-CU-ADAM
- Status last verified
- Jul 2021
- First submitted
- 20 Aug 2017
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 18567642Hildreth 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 23533227Schwarz 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 22783306Kadi 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 10664066Gardner 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 24344218Kralik 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 at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male (ADAM)
- ClinicalTrials.gov ID
- NCT03282682
- Acronym / sponsor ID
- FSPORT-CU-ADAM
- Keywords
- hypogonadism, aging male, strength training, physical activity, testosterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, Slovak Academy of Sciences
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 5 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| hypogonadal males without TRT | Experimental | Procedure: Strength trainingStrength training |
| hypogonadal males with TRT | Experimental | Procedure: Strength trainingStrength training and regular prescribed testosterone therapy given by participant urologist. |
| healthy eugonadal males | Active comparator | Procedure: Strength trainingStrength training |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of secondary hypogonadism on testosterone replacement therapy, newly diagnosed patients of secondary hypogonadism.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength trainingThe 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. | Procedure or surgery | healthy eugonadal males, hypogonadal males with TRT, hypogonadal males without TRT |
Primary outcome
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.
19 secondary outcomes
Change From Baseline in Fat Mass
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Total Body Mass
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in 10-m Usual Walk Test
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in 10-m Fast Walk Test
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Handgrip Strength
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in The Single Stage Treadmill Walking Test
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Predicted One Repetition Maximum on Leg Press
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Maximal Voluntary Contraction in Benchpress
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in The Short Form Health Survey (SF-36)
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Aging Males' Symptom (AMS) Scale
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Metabolic Parameters
Time frame: 7 days before intervention, 7 days after intervention
Change From Baseline in Liver Function Blood Parameters
Time frame: 7 days before intervention, 14 days after intervention
Change From Baseline in Hormonal Parameters
Time frame: 7 days before intervention, 14 days after intervention
Change From Baseline in Ions
Time frame: 7 days before intervention, 14 days after intervention
Change From Baseline in CRP
Time frame: 7 days before intervention, 14 days after intervention
Change From Baseline in Muscle Fiber Size
Time frame: 7 days before intervention, 14 days after intervention
Change From Baseline in Regulators of Muscle Fiber Size
Time frame: 7 days before intervention, 14 days after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18567642Basaria 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.
- Results publication: PubMed 23533227Hildreth 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.
- Results publication: PubMed 22783306Schwarz 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.
- Results publication: PubMed 10664066Kadi 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.
- Results publication: PubMed 24344218Gardner 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.
- Derived from this study: PubMed 31492775Kralik 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.
- Individual participant dataSharing planned: Undecided
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Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan Sedliak, assoc. prof. principal investigator
Comenius University of Bratislava, Faculty Physical Education and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in people with Hypogonadism, Male and Physical Activity, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Lean Mass (time frame: 7 days before intervention, 7 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282682, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.