Protocol summary

Summary
Objectives: This research will be accomplished with the aim of determining the effect of resistance and endurance exercises on acute response to androgens (testosterone and dehydroepiandrosterone sulfate), cortisol and effective metabolite in middle aged men. Design: Between middle aged men lived in mashhad, 10 men 50 to 60 years old coinciding with research conditions will be selected voluntarily via available selective method. Setting and conduct: After determining VO2peak and maximum muscular strength sessions, subjects will participate in resistance, endurance and control (resting) sessions in a cross-sectional design. Participants: Inclusion criteria are consisted of complete physical and mental health, the absence of symptoms of androgen deficiency and lack of regular exercise training in the last year. Intervention: All of subjects will accomplish a resistance exercise session, an endurance exercise session and a control (resting) session with an interval of 4 day. In the phases of pre, post and 15 minutes after each session, blood sampling will accomplish. Main outcome measures: Primary outcome variables include testosterone, dehydroepiandrosterone sulfate and cortisol and secondary outcome variable is lactate.Keywords: Androgens, Cortisol, Middle aged men, Resistance exercise, Endurance exercise.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102424667N1
Registration date: 2016-11-06, 1395/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-06, 1395/08/16
Registrant information
Name
Amin Ahmadi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 3623 0701
Email address
9214507048@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Ferdowsi University of Mashhad
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-06-22, 1389/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Resistance and Endurance Exercises on Serum Androgens, Cortisol and Lactate Levels in Middle Aged Men
Public title
Effect of exercise training on hormones
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: complete physical and mental health; the absence of symptoms of androgen deficiency; lack of regular exercise training in the last year Exclusion criteria: not wanting to continue working; the disease; using subjects of steroid supplements; cigarette and drugs
Age
From 50 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Physical Education of Ferdowsi University of Mashhad
Street address
Mashhad - Azadi square - Faculty of Physical Education of Ferdowsi University of Mashhad
City
Mashhad
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
8713293020

Health conditions studied

1

Description of health condition studied
Testicular hypofunction
ICD-10 code
E29.1
ICD-10 code description
Testicular hypofunction

Primary outcomes

1

Description
testosterone
Timepoint
Pre , post & immediately after intervention
Method of measurement
Chemilumenecence method

2

Description
Dehydroepiandrosterone sulfate
Timepoint
Pre , post & immediately after intervention
Method of measurement
Chemilumenecence method

3

Description
Cortisol
Timepoint
Pre , post & immediately after intervention
Method of measurement
Chemilumenecence method

Secondary outcomes

1

Description
Lactate
Timepoint
Pre , post & immediately after intervention
Method of measurement
Enzymatic method

Intervention groups

1

Description
The executive stages of this study consisted 7 sessions that all sessions performed between 7 to 10 am with moral committee confirm of faculty of physical education Ferdowsi university of Mashhad. The resistance exercise protocol included 8 motion: chest press, pull down, leg press, elbow flexion, elbow extension, leg flexion and shoulder press. In this protocol, every motion performed as 3 sets of 10 repetitions with 80% of one repetition maximum and 1 minute rest between sets with isotonic contraction machines. The endurance training protocol was a training session by ergometer bicycle, which was carried out by 60 to 70 percent of peak oxygen uptake. In the rest session, subjects sat without exercise or stress. subjects`s Meals were equivalent to 5 kcal per kilogram of body weight containing 65 percent carbohydrates, 20 percent fat and 15 percent protein and the toast and cream cheese with the standard mark were used. In the first session, the body mass index was measured and the health, the nutrition condition and the physical activity assessment questionnaires were completed. The second session, was included measuring body fat percentage and body composition by body composition analyzer (Inbody 720) made in South Korea, medical examinations, familiarity with how to research and completing the ethical consent form. In the third session, maximum oxygen consumption was determined with Astrand aerobic fitness test. The fourth session was dedicated to determine the maximum strength of the muscles involved in the selective movements using one repetition maximum method. In the fifth, sixth and seventh sessions, resistance exercise, endurance exercise and rest (control session) was administered with taking time about 45 minutes in each session after spending 2.5 hours of meals.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahad Daneshgahi Laboratory of Mashhad
Full name of responsible person
Dr Ali Akbar Shamsian
Street address
Jahad Daneshgahi Laboratory of Mashhad, Razi avenue, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahad Daneshgahi of Mashhad
Full name of responsible person
Dr Ali Akbar Shamsian
Street address
Jahad Daneshgahi of Mashhad, Campus of Ferdowsi University of Mashhad, Azadi Square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahad Daneshgahi of Mashhad
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Amin Ahmadi
Position
PhD student
Other areas of specialty/work
Street address
Hakim Sabzevari University, Tohid Shahr, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 3623 0701
Fax
Email
amin.ahmadi83@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Amin Ahmadi
Position
PhD student
Other areas of specialty/work
Street address
Hakim Sabzevari University, Tohid Shahr, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 3623 0701
Fax
Email
amin.ahmadi83@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Amin Ahmadi
Position
PhD student
Other areas of specialty/work
Street address
Sabzevar - Tohidshahr - Hakim Sabzevari University
City
Sabzevar
Postal code
Phone
+98 51 3623 0701
Fax
Email
amin.ahmadi83@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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