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Physical Exercise for Men With Andropause (DAEM)

Primary Purpose

Androgen Deficiency, Depressive Symptoms, Stress, Psychological

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Concurrent training
Eurycoma longifolia
Sponsored by
Laboratório de Pesquisa em Lazer e Atividade Física
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgen Deficiency focused on measuring andropause, depressive symptoms, stress, abdominal Obesity, testosterone, erectile dysfunction

Eligibility Criteria

40 Years - 59 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Santa Catarina State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

Exercise group + supplementation

Control group + supplementation

Exercise group + placebo

Control group + placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Androgen deficiency in the aging male
"AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms

Secondary Outcome Measures

Cardiorespiratory fitness
Submaximal ergometric test - Expiratory flow volume
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)
Percent fat
Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%)
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
Muscle strength
Computer based multifunctional dynamometer system - Maximal repetitions
Symptoms of depression
BDI - Beck's Depression Inventory - No symptoms of depression, mild symptoms of depression, moderate symptoms of depression, severe symptoms of depression
Stress level
Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level
Testosterone levels
Blood test - Limits below <220 pmol/l (indication of ADAM)
Sexual satisfaction
IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life

Full Information

First Posted
May 10, 2017
Last Updated
August 12, 2019
Sponsor
Laboratório de Pesquisa em Lazer e Atividade Física
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1. Study Identification

Unique Protocol Identification Number
NCT03150225
Brief Title
Physical Exercise for Men With Andropause
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratório de Pesquisa em Lazer e Atividade Física

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgen Deficiency, Depressive Symptoms, Stress, Psychological, Abdominal Obesity, Testosterone Deficiency, Erectile Dysfunction
Keywords
andropause, depressive symptoms, stress, abdominal Obesity, testosterone, erectile dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The study will have a double-blind blindness, performed in the process of randomization of the participants, who will not be informed about the allocation of the groups, and in the period of data collection and application of the concurrtent training protocol, in which the Researchers who will carry out the data collection will not participate in the application of the protocol, and vice versa.
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group + supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group + supplementation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise group + placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group + placebo
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Concurrent training
Intervention 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Eurycoma longifolia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Androgen deficiency in the aging male
Description
"AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms
Time Frame
five minutes
Secondary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
Submaximal ergometric test - Expiratory flow volume
Time Frame
10 minutes
Title
Body mass index
Description
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)
Time Frame
5 minutes
Title
Percent fat
Description
Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%)
Time Frame
10 minutes
Title
Waist circumference
Description
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
Time Frame
5 minutes
Title
Muscle strength
Description
Computer based multifunctional dynamometer system - Maximal repetitions
Time Frame
10 minutes
Title
Symptoms of depression
Description
BDI - Beck's Depression Inventory - No symptoms of depression, mild symptoms of depression, moderate symptoms of depression, severe symptoms of depression
Time Frame
5 minutes
Title
Stress level
Description
Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level
Time Frame
5 minutes
Title
Testosterone levels
Description
Blood test - Limits below <220 pmol/l (indication of ADAM)
Time Frame
5 minutes
Title
Sexual satisfaction
Description
IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life
Time Frame
10 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa CS Vieira, MSc
Phone
55 48 991665128
Email
mecarvalho.s@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa CS Vieira, MSc
Organizational Affiliation
Santa Catarina State University - Florianópolis, SC, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adriana CA Guimarães, PhD
Organizational Affiliation
Santa Catarina State University - Florianópolis, SC, Brazil
Official's Role
Study Director
Facility Information:
Facility Name
Santa Catarina State University
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88080-350
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Vieira, MsC
Phone
+5548991665125
Email
mecarvalho.s@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Exercise for Men With Andropause

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