Physical Exercise for Men With Andropause (DAEM)

The Impact of Physical Exercise on Androgen Deficiency of Male Aging in Physical, Psychological, Hormonal and Sexual Aspects: a Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Stress, Psychological; Erectile Dysfunction; Depressive Symptoms; Testosterone Deficiency; Abdominal Obesity; Androgen Deficiency
• Intervention / Treatment: Other: Concurrent training; Dietary supplement: Eurycoma longifolia

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,

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88080-350
      • Recruiting
      • Santa Catarina State University
      • Contact: Melissa Vieira, MsC; Phone Number: +5548991665125; Email: mecarvalho.s@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group + supplementation; It will be composed of participants randomly assigned to this group, reinforcing the importance of attendance in classes (minimum of 75% of frequency) for significant health benefits. The evaluation measures will be made through a self-administered questionnaire and physical evaluations (cardiorespiratory fitness, body mass index, percentage of fat, waist circumference and muscular strength). The intervention with the concurrent training will be carried out in a gymnasium in Florianópolis, Santa Catarina. After all the evaluation procedures have been performed, the intervention period will begin, being three times a week, lasting 60 minutes, according to the study protocol. In addition participants will receive supplementation of Eurycoma longifolia in 200mg capsules with standardized extract in aqueous-soluble extract and should be taken daily.	Other: Concurrent training; 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.; Dietary supplement: Eurycoma longifolia; Eurycoma longifolia will be administered by supplementation with the standard aqueous-soluble extract extract (Physta ™) in single 200mg capsules daily, and placebo by starch capsules. The supplementatio will last six months.
Active Comparator: Control group + supplementation; Will be reinforced to the participants of this group the importance of maintaining their daily activities. In addition participants will receive supplementation of Eurycoma longifolia in 200mg capsules with standardized extract in aqueous-soluble extract and should be taken daily.	Dietary supplement: Eurycoma longifolia; Eurycoma longifolia will be administered by supplementation with the standard aqueous-soluble extract extract (Physta ™) in single 200mg capsules daily, and placebo by starch capsules. The supplementatio will last six months.
Experimental: Exercise group + placebo; It will be composed of participants randomly assigned to this group, reinforcing the importance of attendance in classes (minimum of 75% of frequency) for significant health benefits. The evaluation measures will be made through a self-administered questionnaire and physical evaluations (cardiorespiratory fitness, body mass index, percentage of fat, waist circumference and muscular strength). The intervention with the concurrent training will be carried out in a gymnasium in Florianópolis, Santa Catarina. After all the evaluation procedures have been performed, the intervention period will begin, being three times a week, lasting 60 minutes, according to the study protocol. In addition participants will receive starch capsules to be taken daily.	Other: Concurrent training; 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.
No Intervention: Control group + placebo; Will be reinforced to the participants of this group the importance of maintaining their daily activities. In addition participants will receive starch capsules to be taken daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Androgen deficiency in the aging male	"AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms	five minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness	Submaximal ergometric test - Expiratory flow volume	10 minutes
Body mass index	Body mass (Kg) divided by the square of the height (m2) - Normal (up to 24.9 Kg/m2), overweight (from 25 Kg/m2 to 29.9 Kg/m2) & obesity (above 30 Kg/m2)	5 minutes
Percent fat	Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%)	10 minutes
Waist circumference	The waist circumference will be measured at the natural waist level, the mean point between the upper anterior iliac crest and the last rib - Level 1 - increased cardiovascular risk; level 2 - substantially increased cardiovascular risk	5 minutes
Muscle strength	Computer based multifunctional dynamometer system - Maximal repetitions	10 minutes
Symptoms of depression	BDI - Beck's Depression Inventory - No symptoms of depression, mild symptoms of depression, moderate symptoms of depression, severe symptoms of depression	5 minutes
Stress level	Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level	5 minutes
Testosterone levels	Blood test - Limits below <220 pmol/l (indication of ADAM)	5 minutes
Sexual satisfaction	IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life	10 minutes

Collaborators and Investigators

• Sponsor: Laboratório de Pesquisa em Lazer e Atividade Física
• Investigators: Principal Investigator: Melissa CS Vieira, MSc, Santa Catarina State University - Florianópolis, SC, Brazil; Study Director: Adriana CA Guimarães, PhD, Santa Catarina State University - Florianópolis, SC, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): October 31, 2019

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: stress; erectile dysfunction; andropause; testosterone; depressive symptoms; abdominal Obesity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Overnutrition; Nutrition Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Obesity; Depression; Stress, Psychological; Erectile Dysfunction; Obesity, Abdominal
• Other Study ID Numbers: 2.011.641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No