The effects of different exercise training modalities as a treatment and prevention strategies on body composition measures in association with semen parameters in married middle-age fertile and at-risk infertile patients.
To investigate the effects of different exercise training modalities as a treatment and prevention strategies on body composition measures in association with semen parameters in married middle-age fertile and at-risk infertile patients.
Design
2,500 infertile men will be classified into various subgroups of infertility, including asthenozoospermic, asthenotratozoospermic, oligospermic, oligoasthenosospermic, and oligo asthenotratosospermic. Also, 600 inactive middle-aged married men with no fertility problems will participate in the present study as subjects (healthy or fertile group).
After screening and in the first step, the subjects in different subgroups of infertility and also healthy tests will randomly be allocated (based on the table of random numbers) to one of the 5 groups including 1- moderate-intensity aerobic exercise, 2- high-intensity intensity continues, 3- high-intensity interval training, 4- resistance training, and 5- combined activities (moderate and resistance training). Then in the second step, the subjects in each of the mentioned groups will be randomly divided into physical activity groups or control groups.
Settings and conduct
This project will be implemented in Tehran with the cooperation of official reproductive medicine centers as well as clubs and sports centers in different parts of Tehran and under the supervision of the Faculty of Physical Education of the Allameh Tabatabai University of Tehran.
Participants/Inclusion and exclusion criteria
Physically active men
Single men
Men with chronic illnesses
Smokers and men with alcohol consumption
Intervention groups
Moderate-intensity continuous training
High-intensity continuous training
High-intensity interval training
Resistance training
Combined aerobic and resistance training
Non-exercise group (control)
Main outcome variables
Body composition; semen quality parameters, blood levels of hormones
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160605028270N2
Registration date:2020-08-07, 1399/05/17
Registration timing:prospective
Last update:2020-08-07, 1399/05/17
Update count:0
Registration date
2020-08-07, 1399/05/17
Registrant information
Name
Behzad Hajizadeh Maleki
Name of organization / entity
Department of Sports Medicine, Institute of Sports Sciences, Justus-Liebig-University
Country
Iran (Islamic Republic of)
Phone
+49 641 9925210
Email address
behzad.hajizadeh-maleki@sport.uni-giessen.de
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of different exercise training modalities as a treatment and prevention strategies on body composition measures in association with semen parameters in married middle-age fertile and at-risk infertile patients.
Public title
The effects of different exercise training modalities as a treatment and prevention strategies on body composition measures in association with semen parameters in married middle age fertile and at-risk infertile patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sedentary
Married
Free from chronic illnesses
Non smokers and no alcohol dependency
Exclusion criteria:
Physically active men
Single men
Men with chronic illnesses
Smokers and men with alcohol consumption
Age
From 25 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3100
More than 1 sample in each individual
Number of samples in each individual:
5
The initial semen sample will drawn 24 h before the training session (baseline; T1). Additional samples will collect 24 h after the last training session inweek 12 (T2), 24 h after the last training session in week 24 (T3), andat 7 (T4) and 30 days (T5) post-intervention
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by random
number generation and group assignment will be placed in a sealed
envelope, which will be opened by the study coordinator at the time
of randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Allameh Tabatabai University
Street address
Dehkadeh-ye-Olympic, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
1489684511
Approval date
2020-07-21, 1399/04/31
Ethics committee reference number
IR.ATU.REC.1399.012
Health conditions studied
1
Description of health condition studied
Male factor infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body composition, semen quality and blood hormonal levels
Timepoint
At baseline,12 weeks, 24 weeks and 7 and 30 days after training.
Method of measurement
Body composition variables including weight and height of subjects will be assessed using ZT-120 Weighing Machine Floor Type - made in Germany. Fat percentage and body mass index will be assessed using Omron portable fat meter made in Germany and waist circumference will be assessed by a tape measure. Semen variables will be evaluated according to World Health Organization(WHO) guidelines for the examination of human semen . Blood hormones will be measured using special kits by ELISA method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: moderate-intensity continuous exercise training
Category
Treatment - Other
2
Description
Intervention group: high-intensity interval training
Category
Treatment - Other
3
Description
Intervention group: high-intensity continuous
Category
Treatment - Other
4
Description
Intervention group: resistance training
Category
Treatment - Other
5
Description
Intervention group: combined aerobic and resistance training
Category
Treatment - Other
6
Description
Control group: Non-exercise group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Physical Education, Allameh Tabatabai University
Full name of responsible person
Bakhtyar Tartibian
Street address
Dehkade-ye Olampik, West Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 4112
Email
ba.tartibian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Bakhtyar Tartibian
Street address
Dehkade-ye Olampik, West Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4473 7636
Email
ba.tartibian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?