Androgen DeficiencyDAEMNCT03150225
Physical Exercise for Men With Andropause
A study testing Concurrent training and Eurycoma longifolia in people with Androgen Deficiency and Depressive Symptoms, run by Laboratório de Pesquisa em Lazer e Atividade Física at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgen Deficiency, Depressive Symptoms, Stress, Psychological
- What is being tested?
- Concurrent training and Eurycoma longifolia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2019to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men presenting ADAM according to their responses on the Aging Male Symptoms Scale and testosterone levels <220 pmol/l
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Santa Catarina State University
Florianópolis, Santa Catarina, 88080-350
Melissa Vieira, MsC, +5548991665125, mecarvalho.s@gmail.com
About this study
Official 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.
Read the 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,
- Conditions
- Androgen Deficiency, Depressive Symptoms, Stress, Psychological, Abdominal Obesity, Testosterone Deficiency, Erectile Dysfunction
- Being tested
- Concurrent training, Eurycoma longifolia
- Keywords
- andropause, depressive symptoms, stress, abdominal Obesity, testosterone, erectile dysfunction
- Medical subject headings
- Depression, Stress, Psychological, Obesity, Abdominal, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent trainingOther
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 longifoliaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Androgen deficiency in the aging male
"AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms
Measured: five minutes
Secondary outcomes (9)
Cardiorespiratory fitness
Submaximal ergometric test - Expiratory flow volume
Measured: 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)
Measured: 5 minutes
Percent fat
Ultrasound (triceps, abdominal and subscapular adipose tissue) - Results in percentage (%)
Measured: 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
Measured: 5 minutes
Muscle strength
Computer based multifunctional dynamometer system - Maximal repetitions
Measured: 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
Measured: 5 minutes
Stress level
Perceived stress scale - The scores can vary from 0 to 56, the nearer to 56 the greater the stress level
Measured: 5 minutes
Testosterone levels
Blood test - Limits below <220 pmol/l (indication of ADAM)
Measured: 5 minutes
Sexual satisfaction
IEFI International Erectile Function Index - Good sexual quality of life Bad sexual quality of life
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Apr 2019
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgen DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório de Pesquisa em Lazer e Atividade Física
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa CS Vieira, MSc, Principal investigator, Santa Catarina State University - Florianópolis, SC, BrazilAdriana CA Guimarães, PhD, Study director, Santa Catarina State University - Florianópolis, SC, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150225
- Sponsor's protocol ID
- 2.011.641
- Acronym
- DAEM
- Status last verified
- Aug 2019
- First submitted
- 10 May 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Physical Exercise on Androgen Deficiency of Male Aging in Physical, Psychological, Hormonal and Sexual Aspects: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03150225
- Acronym / sponsor ID
- DAEM / 2.011.641
- Conditions
- Androgen Deficiency, Depressive Symptoms, Stress, Psychological, Abdominal Obesity, Testosterone Deficiency, Erectile Dysfunction
- Keywords
- andropause, depressive symptoms, stress, abdominal Obesity, testosterone, erectile dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Laboratório de Pesquisa em Lazer e Atividade FísicaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise group + supplementation | Experimental | Other: Concurrent training, Dietary Supplement: Eurycoma longifoliaIt 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. |
| Control group + supplementation | Active comparator | Dietary Supplement: Eurycoma longifoliaWill 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 + placebo | Experimental | Other: Concurrent trainingIt 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. |
| 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. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- men presenting ADAM according to their responses on the Aging Male Symptoms Scale and testosterone levels <220 pmol/l
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent trainingIn 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. | Other | Exercise group + placebo, Exercise group + supplementation |
| Eurycoma longifoliaEurycoma 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. | Dietary supplement | Control group + supplementation, Exercise group + supplementation |
Primary outcome
Androgen deficiency in the aging male
Time frame: five minutes
"AGING MALE SYMPTOMS SCALE" With symptoms, without symptoms; Mild, moderate and severe symptoms
9 secondary outcomes
Cardiorespiratory fitness
Time frame: 10 minutes
Body mass index
Time frame: 5 minutes
Percent fat
Time frame: 10 minutes
Waist circumference
Time frame: 5 minutes
Muscle strength
Time frame: 10 minutes
Symptoms of depression
Time frame: 5 minutes
Stress level
Time frame: 5 minutes
Testosterone levels
Time frame: 5 minutes
Sexual satisfaction
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa CS Vieira, MSc principal investigator
Santa Catarina State University - Florianópolis, SC, Brazil
Adriana CA Guimarães, PhD study director
Santa Catarina State University - Florianópolis, SC, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent training and Eurycoma longifolia in people with Androgen Deficiency and Depressive Symptoms, run by Laboratório de Pesquisa em Lazer e Atividade Física at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa CS Vieira, MSc (55 48 991665128, mecarvalho.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Androgen deficiency in the aging male (time frame: five minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.