Physical Exercise for Men With Andropause

Erectile Dysfunction Clinical Trial

— DAEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150225
• Other study ID #: 2.011.641
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: August 2019
• Source: Laboratório de Pesquisa em Lazer e Atividade Física
• Contact: Melissa CS Vieira, MSc
• Phone: 55 48 991665128
• Email: mecarvalho.s[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Androgen Deficiency
• Depression
• Depressive Symptoms
• Erectile Dysfunction
• Obesity, Abdominal
• Stress, Psychological
• Testosterone Deficiency

Intervention

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.

Locations

Country	Name	City	State
Brazil	Santa Catarina State University	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Laboratório de Pesquisa em Lazer e Atividade Física

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Androgen deficiency in the aging male	"AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms	five minutes
Secondary	Cardiorespiratory fitness	Submaximal ergometric test - Expiratory flow volume	10 minutes
Secondary	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
Secondary	Percent fat	Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%)	10 minutes
Secondary	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
Secondary	Muscle strength	Computer based multifunctional dynamometer system - Maximal repetitions	10 minutes
Secondary	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
Secondary	Stress level	Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level	5 minutes
Secondary	Testosterone levels	Blood test - Limits below <220 pmol/l (indication of ADAM)	5 minutes
Secondary	Sexual satisfaction	IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life	10 minutes