N/A N=22 Basic Science

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

Hypogonadism, Male · Physical Activity · Testosterone Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT03282682 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Change From Baseline in Lean Mass — 2734; 499; 2268 grams

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Strength training (Procedure)
Age: Adult · 45+ yrs
Sex: Male
Sponsor: Comenius University
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Lean Mass	2734; 499; 2268	—
SECONDARY Change From Baseline in Fat Mass	-1969; -1263; -755	—
SECONDARY Change From Baseline in Total Body Mass	621.53; -821.73; 1435.04	—
SECONDARY Change From Baseline in 10-m Usual Walk Test	0; -0.06; -0.05	—
SECONDARY Change From Baseline in 10-m Fast Walk Test	0.05; -0.1; -0.13	—
SECONDARY Change From Baseline in Handgrip Strength	-1.41; 0.84; -0.02	—
SECONDARY Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension	-9.65; 8.15; 1.35	—
SECONDARY Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion	2.32; 24.64; 14.36	—
SECONDARY Change From Baseline in The Single Stage Treadmill Walking Test	0.61; 0.25; 0.42	—
SECONDARY Change From Baseline in Predicted One Repetition Maximum on Leg Press	45.31; 51.59; 51.40	—
SECONDARY Change From Baseline in Maximal Voluntary Contraction in Benchpress	-6.49; 64.31; 66.68	—
SECONDARY Change From Baseline in The Short Form Health Survey (SF-36)	2.50; 7.50; 3.75	—
SECONDARY Change From Baseline in Aging Males' Symptom (AMS) Scale	-4.83; -2.00; -6.25	—
SECONDARY Change From Baseline in Metabolic Parameters	0.0006; 0.0008; -0.003; -0.006; -0.0002; 0.0011	—
SECONDARY Change From Baseline in Liver Function Blood Parameters	0.06; 0.05; 0.10; 0.19; -0.05; -0.07	—
SECONDARY Change From Baseline in Hormonal Parameters	1.69; -0.50; -1.99; 2.42; -1.35; -2.93	—
SECONDARY Change From Baseline in Ions	-1.47; -0.77; -0.33; 0.17; 0.06; 0.14	—
SECONDARY Change From Baseline in CRP	0.02; 0.13; -1.67	—
SECONDARY Change From Baseline in Muscle Fiber Size	—	—
SECONDARY Change From Baseline in Regulators of Muscle Fiber Size	—	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03282682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.