Clinical trial NCT03150225: Physical Exercise for Men With Andropause
Official title: The Impact of Physical Exercise on Androgen Deficiency of Male Aging in Physical, Psychological, Hormonal and Sexual Aspects: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Androgen Deficiency
Depressive Symptoms
Stress, Psychological
Abdominal Obesity
Testosterone Deficiency
Erectile Dysfunction
Keywords: andropause
depressive symptoms
stress
abdominal Obesity
testosterone
erectile dysfunction
Lead sponsor: Laboratório de Pesquisa em Lazer e Atividade Física
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 58
Sex: MALE
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization of the men who will participate in the study will be carried out through a computer program; In the four groups that will compose the study: exercise group + supplementation - intervention with application of a concurrent training protocol for six months and supplementation with eurycoma longifolia, 200mg once daily; exercise group + placebo intervention with application of a concurrent training protocol for six months and administration of starch capsules; control group + supplementation - monthly will be contacted via telephone and will be encouraged to maintain their daily activities and supplementation with eurycoma longifolia, 200mg once daily; control group + placebo - monthly will be contacted via telephone and will be encouraged to maintain their daily activities and administration of starch capsules.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze the impact of physical exercise through a protocol of concurrent training in the psychological, physical, hormonal and sexual aspects in middle aged men with androgen deficiency in the aging male (ADAM). The study design with randomized clinical trial, comprising men in middle age (40 to 59 years) with ADAM, should be divided into two groups: 1) Control group (CG); 2) Experimental group (EG). Information related to sociodemographic and clinical profile will be collected; Psychological aspects (depressive and anxiety symptoms - Hospital Anxiety and Depression Scale ; stress - Perceived Stress Scale); Physical acpects (IMC; Percentage of body fat; Abdominal obesity - waist circumference in cm; Muscle strength - Biodex System 4 PRO isokinetic dynamometer; cardiorespiratory Fitness - Cycle-ergometer - CASE ECG Stress Testing System, General Electric Medical Systems, Milwaukee, WI); Hormonal aspects (total and free testosterone - blood collection); Sexual Aspect (Sexual satisfaction- International Index of Erectile Function); DAEM (scale of symptoms of aging). Apply a physical exercise protocol using the functional training method over a six-month period. All information will be collected before and after the intervention period. For statistical analysis, use the SPSS statistical package, version 20.0. (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of statistical tests.

Detailed description: In this protocol the participants will perform aerobic and resistance training according to published evidence for middle-aged men; Characterized as concurrent training.

The protocol will last six months and will be divided into two quarters. In the first trimester, initial 30 minutes will be assigned to resistance training, followed by 30 minutes of aerobic training; Already in the second trimester will be 20 initial minutes for the aerobic training and later 40 minutes for the resistance training; Aiming to obtain benefits in the levels of muscular strength, aerobic capacity, body composition, besides positive results in relation to the hormonal adaptations of testosterone, as well as in the psychological well being of the participants.

Classes will occur at a frequency of three times weekly, lasting 60 minutes a session.

For the elaboration of this protocol will be followed the guidelines of the American College of Sports Medicine of resistance training for healthy adults The aerobic training of this protocol will follow the American College of Sports Medicine's prescription prescription guidelines for the health of healthy adult subjects,

Eligibility criteria: Inclusion Criteria:

* men presenting ADAM according to their responses on the Aging Male Symptoms Scale and testosterone levels \<220 pmol/l

Exclusion Criteria:

* history of neurological or musculoskeletal diseases or who have prostate cancer will be excluded, as also those who have been submitted toresistance and/or aerobic in the three months prior to data collection

Primary outcomes:
measure: Androgen deficiency in the aging male
timeFrame: five minutes
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: 10 minutes
measure: Body mass index
timeFrame: 5 minutes
measure: Percent fat
timeFrame: 10 minutes
measure: Waist circumference
timeFrame: 5 minutes
measure: Muscle strength
timeFrame: 10 minutes
measure: Symptoms of depression
timeFrame: 5 minutes
measure: Stress level
timeFrame: 5 minutes
measure: Testosterone levels
timeFrame: 5 minutes
measure: Sexual satisfaction
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Santa Catarina State University
state: Santa Catarina
Study officials:
affiliation: Santa Catarina State University - Florianópolis, SC, Brazil
name: Melissa CS Vieira, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Catarina State University - Florianópolis, SC, Brazil
name: Adriana CA Guimarães, PhD
role: STUDY_DIRECTOR
References: