Erectile Dysfunction Clinical Trial
— DAEMOfficial title:
The Impact of Physical Exercise on Androgen Deficiency of Male Aging in Physical, Psychological, Hormonal and Sexual Aspects: a Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | October 31, 2019 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years to 59 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Santa Catarina State University | Florianópolis | Santa Catarina |
Lead Sponsor | Collaborator |
---|---|
Laboratório de Pesquisa em Lazer e Atividade Física |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Androgen deficiency in the aging male | "AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms | five minutes | |
Secondary | Cardiorespiratory fitness | Submaximal ergometric test - Expiratory flow volume | 10 minutes | |
Secondary | 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) | 5 minutes | |
Secondary | Percent fat | Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%) | 10 minutes | |
Secondary | 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 | 5 minutes | |
Secondary | Muscle strength | Computer based multifunctional dynamometer system - Maximal repetitions | 10 minutes | |
Secondary | Symptoms of depression | BDI - Beck's Depression Inventory - No symptoms of depression, mild symptoms of depression, moderate symptoms of depression, severe symptoms of depression | 5 minutes | |
Secondary | Stress level | Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level | 5 minutes | |
Secondary | Testosterone levels | Blood test - Limits below <220 pmol/l (indication of ADAM) | 5 minutes | |
Secondary | Sexual satisfaction | IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life | 10 minutes |
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