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

NCT03282682 | Completed Results

• 1 other identifier: FSPORT-CU-ADAM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism, Male; Physical Activity; Testosterone Deficiency

Keywords

hypogonadism; aging male; strength training; physical activity; testosterone

Outcome Measures

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.

  7 days before intervention, 7 days after intervention

Secondary Outcomes (19)

• Change From Baseline in Fat Mass

  7 days before intervention, 7 days after intervention

• Change From Baseline in Total Body Mass

  7 days before intervention, 7 days after intervention

• Change From Baseline in 10-m Usual Walk Test

  7 days before intervention, 7 days after intervention

• Change From Baseline in 10-m Fast Walk Test

  7 days before intervention, 7 days after intervention

• Change From Baseline in Handgrip Strength

  7 days before intervention, 7 days after intervention

Study Arms (3)

hypogonadal males without TRT

EXPERIMENTAL

Strength training

Procedure: Strength training

hypogonadal males with TRT

EXPERIMENTAL

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

Procedure: Strength training

healthy eugonadal males

ACTIVE COMPARATOR

Strength training

Procedure: Strength training

Interventions

Strength training PROCEDURE

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.

healthy eugonadal males; hypogonadal males with TRT; hypogonadal males without TRT

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Comenius University: lead
• Norwegian School of Sport Sciences: collaborator
• Slovak Academy of Sciences: collaborator

Study Sites (1)

Comenius University in Bratislava, Faculty of physical education and sport

Bratislava, 814 69, Slovakia

Location

Related Publications (6)

• 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.

  PMID: 18567642 RESULT

• 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.

  PMID: 23533227 RESULT

• 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.

  PMID: 22783306 RESULT

• 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.

  PMID: 10664066 RESULT

• 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.

  PMID: 24344218 RESULT

• 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.

  PMID: 31492775 DERIVED

MeSH Terms

Conditions

Eunuchism; Motor Activity; Hypogonadism

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The major limit of the study was low number of the newly diagnosed patients.

Results Point of Contact

• Title: Doc. Mgr. Milan Sedliak, PhD.
• Organization: Comenius University in Bratislava

milan.sedliak@uniba.sk

+421918340671

Study Officials

• Milan Sedliak, assoc. prof.

  Comenius University of Bratislava, Faculty Physical Education and Sport

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Independent researcher, Vice-dean for science, research and international cooperation

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: September 14, 2017
• Study Start: October 1, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: July 30, 2021
• Results First Posted: May 5, 2020

Record last verified: 2021-07

Locations

SL (1)