Physical Exercise for Men With Andropause

NCT03150225 | Unknown DMC

• 1 other identifier: 2.011.641
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

andropause; depressive symptoms; stress; abdominal Obesity; testosterone; erectile dysfunction

Outcome Measures

Primary Outcomes (1)

• Androgen deficiency in the aging male

  "AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms

  five minutes

Secondary Outcomes (9)

• Cardiorespiratory fitness

  10 minutes

• Body mass index

  5 minutes

• Percent fat

  10 minutes

• Waist circumference

  5 minutes

• Muscle strength

  10 minutes

Study Arms (4)

Exercise group + supplementation

EXPERIMENTAL

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; Dietary Supplement: Eurycoma longifolia

Control group + supplementation

ACTIVE COMPARATOR

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

Exercise group + placebo

EXPERIMENTAL

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

Control group + placebo

NO INTERVENTION

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.

Interventions

Concurrent training OTHER

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.

Exercise group + placebo; Exercise group + supplementation

Eurycoma longifolia DIETARY_SUPPLEMENT

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.

Control group + supplementation; Exercise group + supplementation

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratório de Pesquisa em Lazer e Atividade Física: lead

Study Sites (1)

Santa Catarina State University

Florianópolis, Santa Catarina, 88080-350, Brazil

RECRUITING

MeSH Terms

Conditions

Depression; Stress, Psychological; Obesity, Abdominal; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Melissa CS Vieira, MSc

  Santa Catarina State University - Florianópolis, SC, Brazil

  PRINCIPAL INVESTIGATOR

• Adriana CA Guimarães, PhD

  Santa Catarina State University - Florianópolis, SC, Brazil

  STUDY DIRECTOR

Central Study Contacts

Melissa CS Vieira, MSc

CONTACT

55 48 991665128; mecarvalho.s@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: April 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)