An interventional study of Concurrent training and Eurycoma longifolia in Androgen Deficiency, Depressive Symptoms and Stress, Psychological, sponsored by Laboratório de Pesquisa em Lazer e Atividade Física. Status unknown at 1 site in Brazil. Open to male participants aged 40 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Laboratório de Pesquisa em Lazer e Atividade Física · Not applicable, Interventional, and Treatment
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.
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,
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's planned enrollment of 58 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Laboratório de Pesquisa em Lazer e Atividade Física is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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
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.
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.
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.
Androgen deficiency in the aging male
"AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms
Time frame: five minutes
Cardiorespiratory fitness
Submaximal ergometric test - Expiratory flow volume
Time frame: 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)
Time frame: 5 minutes
Percent fat
Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%)
Time frame: 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
Time frame: 5 minutes
Muscle strength
Computer based multifunctional dynamometer system - Maximal repetitions
Time frame: 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
Time frame: 5 minutes
Stress level
Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level
Time frame: 5 minutes
Testosterone levels
Blood test - Limits below \<220 pmol/l (indication of ADAM)
Time frame: 5 minutes
Sexual satisfaction
IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life
Time frame: 10 minutes
Plan to share: No
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Laboratório de Pesquisa em Lazer e Atividade Física