Study of the effect of resistance exercise on serum testosterone levels, severity signs of aging and quality of life in middle-aged men with late-onset hypogonadism
Study of the effect of resistance exercise on testosterone levels and the health of men with hypogonadism
Design
Clinical trial with control and intervention group -Based on disease diagnosis and pragmatic - randomized random block method
Settings and conduct
In this study, after completing the sample size, the available individuals referring to the specialized clinic of Imam Khomeini Hospital of Ahvaz were randomly divided into two groups of control and intervention group and then the control group for one month and three weeks each week One hour of resistance exercise with weight and after the end of intervention, the two groups are examined for the variables considered.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1. man
2.Married
3.Age 40-65 year
4. Diagnosis of hypogonadism
Exclusion criteria:
1. Mental illness
2. Physical limitations in exercising
3. Have a regular physical exercise in the last three months
4. Use of ergogenic supplements before the study
Intervention groups
Intervention group:
Group receiving a combination of resistance exercise with weights
control group :
A group that continues its lifestyle
Main outcome variables
1.Serum testosterone level
2.Severe aging symptoms
3.Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190105042244N1
Registration date:2019-03-02, 1397/12/11
Registration timing:retrospective
Last update:2019-03-02, 1397/12/11
Update count:0
Registration date
2019-03-02, 1397/12/11
Registrant information
Name
Hamid Taghipoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4352 1784
Email address
taghipoor.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-31, 1397/10/10
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
2018-12-31, 1397/10/10
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-05-20, 1398/02/30
Scientific title
Study of the effect of resistance exercise on serum testosterone levels, severity signs of aging and quality of life in middle-aged men with late-onset hypogonadism
Public title
The effect of resistance exercise on serum testosterone levels in middle aged men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Married
Age 65-40 years old
The score obtained from the aging mals symptom questionnaire is greater than 27
Diagnosis of late men's hypogonadism based on serum testosterone level
Exclusion criteria:
Acute mental illness and not having acceptable general health
Physical Limit for Exercise
Tobacco and alcohol consumption
Perform regular resistance training in the last three months
Use of ergogenic supplements before the study
Age
From 40 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning samples to the experimental and control groups was randomized and random blocked blocks with block size 6(Using the table for random permissions).A randomized list is provided by a statistician.According to a randomized list, it is allocated by a person outside the study according to the codes for each disease that is included in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The study sample consisted of 60 available patients who entered the study according to the criteria of inclusion and then divided into two groups of test and control by random allocation method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan Highway. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.AJUMS.REC.1397.724
Health conditions studied
1
Description of health condition studied
late-onset hypogonadism
ICD-10 code
E29.1
ICD-10 code description
Testicular hypofunction
2
Description of health condition studied
late-onset hypogonadism
ICD-10 code
E29.1
ICD-10 code description
Testicular hypofunction
Primary outcomes
1
Description
Serum total testosterone
Timepoint
Before and after intervention
Method of measurement
Elisa biochemical assay
2
Description
Severe aging symptoms
Timepoint
Before and after intervention
Method of measurement
Using aging male Symptoms Questionnaire
3
Description
Quality of Life
Timepoint
Before and after intervention
Method of measurement
Measured using SF-36 questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For men in the intervention group, serum testosterone levels, severity of aging symptoms and quality of life were measured first, and then the intervention group performed resistance exercise for one month. At the end of the intervention, the group again tested for testosterone levels, severity of aging symptoms and quality Life .At the end, the data before and after the intervention are compared with each other and compared to the control group.
Category
Lifestyle
2
Description
Control group:For men in the control group, serum testosterone level, severity of aging symptoms and quality of life were measured first. The group then continued their lifestyle for one month. After the study was completed, the group again tested the level of testosterone, severity of aging symptoms and quality of life, At the end, the data before and after the study are compared with each other and compared to the intervention group
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialty Clinic of Ahvaz Imam Hospital
Full name of responsible person
Mahin Gheibizadeh
Street address
Golestan Highway - Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2818
Email
Gheibizadeh-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Gheibizadeh
Street address
Golestan Highway - Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
Gheibizadeh-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Gheibizadeh
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Golestan Highway - Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135-15794
Phone
+98 61333738394
Email
Gheibizadeh-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Diniar Khazaali
Position
Facility
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Golestan Highway - Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3222 2922
Email
khazaeli-d@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
hamid taghipoor
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
NO.63- West Shahid Mousavi -Telecommunication Houses
City
Ramhormoz
Province
Khouzestan
Postal code
6381694129
Phone
+98 61 4352 1784
Email
Taghipoor.h@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data of the participating participants will be encrypted and will be published with the privacy of the patient and the confidentiality of the information.
When the data will become available and for how long
The date of access to the data is six months after the publication of the results
To whom data/document is available
Only available to scholars working in academic and academic institutions
Under which criteria data/document could be used
The requirements for access to data include the sending of documents relating to the applicant's membership in academic and academic institutions, and the applicant is authorized to use this data in order to document for subsequent studies.
From where data/document is obtainable
You can use the email address to access the information
1.Gheibizadeh-m@ajums.ac.ir
2.Hamid_taghipoor@yahoo.com
What processes are involved for a request to access data/document
The applicant will send the data to him at least one month later by sending valid credentials to members of the academic and research institutes at the email address of the author.