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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

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.

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

NCT ID

NCT03150225

First Posted

May 10, 2017

Last Updated

August 12, 2019

Sponsor

Laboratório de Pesquisa em Lazer e Atividade Física

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

Studies a U.S. FDA-regulated Device Product

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

Arm Title

Control group + supplementation

Arm Type

Active Comparator

Arm Description

Arm Title

Exercise group + placebo

Arm Type

Experimental

Arm Description

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

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

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

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

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

mecarvalho.s@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Physical Exercise for Men With Andropause

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