| CTRI Number |
CTRI/2022/01/039221 [Registered on: 06/01/2022] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
effect of exercise on male hormones |
|
Scientific Title of Study
|
Subclinical alteration in reproductive hormone profile of males doing exercise and its association with anthropometric parameters
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naresh Parmar |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES Rajkot |
| Address |
PHYSIOLOGY DEPARTMENT
AIIMS TEMPORARY CAMPUS
PDU MEDICAL COLLEGE
Rajkot
GUJARAT
360001
India |
| Phone |
9099024546 |
| Fax |
|
| Email |
parmarnaresh674@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Parmar |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES Rajkot |
| Address |
PHYSIOLOGY DEPARTMENT
AIIMS TEMPORARY CAMPUS
PDU MEDICAL COLLEGE
Rajkot
GUJARAT
360001
India |
| Phone |
9099024546 |
| Fax |
|
| Email |
parmarnaresh674@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh Parmar |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES Rajkot |
| Address |
PHYSIOLOGY DEPARTMENT
AIIMS TEMPORARY CAMPUS
PDU MEDICAL COLLEGE
Rajkot
GUJARAT
360001
India |
| Phone |
9099024546 |
| Fax |
|
| Email |
parmarnaresh674@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RAJKOT |
| Address |
AIIMS RAJKOT |
| Type of Sponsor |
Other [AIIMS RAJKOT] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS RAJKOT |
AIIMS RAJKOT |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NARESH PARMAR |
AIIMS RAJKOT |
room number 103, 1st floor, Department of Physiology
Rajkot
GUJARAT |
9099024546
parmarnaresh674@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee AIIMS RAJKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
HEALTHY EXERCISING ADULTS |
|
| ExclusionCriteria |
| Details |
NO HISTORY OF ANY ILLNESS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. to study the alteration in reproductive hormonal levels in males doing endurance and resistance exercise.
2. to compare the results of hormonal level in endurance exercise, resistance exercise with control group.
|
once (one time measurement) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3.correlation Of reproductive hormonal profile with anthropometric parameters.
|
once (one time measurement) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To investigate the effects of two forms of
exercise, endurance training (running) and resistance training (weight
lifting), on reproductive function in male.
The study will be the cross sectional study and double blind.
Participant will be assigned in to 3 groups after taking informed consent.
Participants assigned into endurance exercise, resistance exercise and control
groups. After that hormonal profile (free and combined testosterone, LH, FSH)
will be assessed and compared.
All the participants will be instructed to do
overnight fast the day before the hormonal profile tests. No alcohol,
chocolate, or caffeine for at least 24 hours and having not exercised for at
least 24 hour. period, blood samples will be drawn at 20-minute intervals for
60 minutes for the determination of resting levels of total T, free T, (LH),
(FSH). All plasma and serum samples will store at -20aC until analysis. Serum
LH and FSH concentrations will be determined via liquid phase double-antibody 1251
RIA or chemo immunoassay (Diagnostic Products).
Regular exercise and physical
activity promote overall health benefits that are hard to ignore. However an
inadequate knowledge and ignorance regarding exercise routines can possibly
lead to harmful side effects particularly hormonal profiles. 60 people selected
for the study doing regular exercise and their reproductive hormonal profile
will be compared with 30 controls having sedentary lifestyle. The main
objective of the study is to investigate the effect of exercise on reproductive
hormones.
Exercise
leads to alteration in hormonal profile leading to infertility (subclinical). |