Physical Exercise for Men With Andropause
- Conditions
- Androgen DeficiencyAbdominal ObesityErectile DysfunctionStress, PsychologicalDepressive SymptomsTestosterone Deficiency
- Interventions
- Dietary Supplement: Eurycoma longifoliaOther: Concurrent training
- Registration Number
- NCT03150225
- Lead Sponsor
- Laboratório de Pesquisa em Lazer e Atividade Física
- 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,
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 58
- men presenting ADAM according to their responses on the Aging Male Symptoms Scale and testosterone levels <220 pmol/l
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group + supplementation 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. Exercise group + supplementation Concurrent training 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. Exercise group + supplementation 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 supplementation of Eurycoma longifolia in 200mg capsules with standardized extract in aqueous-soluble extract and should be taken daily. Exercise group + placebo Concurrent training 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.
- Primary Outcome Measures
Name Time Method Androgen deficiency in the aging male five minutes "AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms
- Secondary Outcome Measures
Name Time Method Stress level 5 minutes Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level
Muscle strength 10 minutes Computer based multifunctional dynamometer system - Maximal repetitions
Body mass index 5 minutes 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)
Symptoms of depression 5 minutes BDI - Beck's Depression Inventory - No symptoms of depression, mild symptoms of depression, moderate symptoms of depression, severe symptoms of depression
Testosterone levels 5 minutes Blood test - Limits below \<220 pmol/l (indication of ADAM)
Sexual satisfaction 10 minutes IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life
Percent fat 10 minutes Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%)
Cardiorespiratory fitness 10 minutes Submaximal ergometric test - Expiratory flow volume
Waist circumference 5 minutes 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
Trial Locations
- Locations (1)
Santa Catarina State University
🇧🇷Florianópolis, Santa Catarina, Brazil