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Comparison of delayed-onset muscle soreness between two groups of healthy untrained female students of Semnan University of Medical Sciences, Does oestrogen have a prophylactic effect?

Protocol summary

Summary
The purpose of this study was to investigate the protective effect of Oestrogen on muscle soreness. 24 healthy untrained female students, ranged between 18-24 years old, voluntarily participated in this study. 12 subjects were in mid-luteal phase of menstrual cycle (high oestrogen level) and other 12 subjects were in mid-follicular phase of menstrual cycle (low oestrogen level). All participants were informed of the procedures and signed written consent before participation. To induce delayed-onset muscle soreness, all participants walked on the Enraf treadmill, declined 10 degrees, with 4 km/h speed, for 30 minutes. This type of walking was accompanied with eccentric contraction of quadriceps and gluteus maximus and concentric contraction of gastrocnemius muscle. Maximal voluntary isometric strength of right and left quadriceps, pressure pain threshold, perceived pain, creatine kinase activity of serum, and thigh circumference were measured and compared in both groups, before intervention, and 24 and 48 hours after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903284203N1
Registration date: 2010-04-21, 1389/02/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-04-21, 1389/02/01
Registrant information
Name
Atefeh Aminian Far
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
aminianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
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
Comparison of delayed-onset muscle soreness between two groups of healthy untrained female students of Semnan University of Medical Sciences, Does oestrogen have a prophylactic effect?
Public title
Muscle Soreness and Protective Effect of Oestrogen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1- aged between 18-25years, 2- giving written consent Exclusion criteria: 1- Neuro-muscular disease, 2- Cardiovascular disease, 3- Diabetes mellitus, 4- Renal failure, 5- Acute herniation, 6- Discopathy, 7- High blood pressure, 8- Asthma and respiratory problems, 9- Acute infection, 10- Recent fracture in skeletal system, 11- Pin, plaques and other fixations in lower limbs, 12- Total hip arthroplasty, 13- Total knee arthroplasty, 14- Cardiac pacemaker, 15- Pregnancy, 16- Previous history of muscular injection a week before intervention, 17- Previous history of participation in body building program, 18- Previous history of participation in aerobic program, 19- unfinished trial sessions, 20- any reluctances to continue and willing to quit the study
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Chancellor dean of Semnan University of Medical Sciences
Street address
Basij Blvd, Semnan University of Medical Sciences
City
Semnan
Postal code
3519899951
Approval date
2010-06-13, 1389/03/23
Ethics committee reference number
5423-الف

Health conditions studied

1

Description of health condition studied
Muscle soreness
ICD-10 code
M79.6
ICD-10 code description
Pain in limb

Primary outcomes

1

Description
Creatine kinase enzyme of serum
Timepoint
Before intervention, 24 and 48 hours after intervention
Method of measurement
Blood sample

Secondary outcomes

1

Description
Maximal voluntary isometric strength of quadriceps muscle
Timepoint
before intervention, 24 and 48 hours after intervention
Method of measurement
With Loadcell, in 100 degrees flexion of knee

2

Description
Perceived pain
Timepoint
Before intervention, 24 and 48 hours after intervention
Method of measurement
A 10-mm Visual Analogue Scale (VAS)

3

Description
Pressure pain threshold
Timepoint
Before intervention, 24 and 48 hours after intervention
Method of measurement
A 20 ml syringe with a spring inside, rounded tip

4

Description
Thigh circumference
Timepoint
Before intervention, 24 and 48 hours after intervention
Method of measurement
A tape measure, at 5, 10 and 15 cm above patella

Intervention groups

1

Description
Doing eccentric exersices for half an hour on treadmill until feeling soreness
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Research Center, Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminian-Far
Street address
Rehabilitation Faculty, Semnan University of Medical Science, Kilometre 5 Damghan road
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Faranoush
Street address
Vice-Chancellor for research, Semnan University of Medical Sciences, Basij Blvd,
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for research, Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminian-Far
Position
MS, instructor, Member of the university
Other areas of specialty/work
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, Kilometre 5 Damghan road,
City
Semnan
Postal code
Phone
+98 23 1335 4182
Fax
+98 23 1335 4209
Email
aminianfar@razi.tums.ac.iraminfar83@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminian-Far
Position
MS, instructor, Member of the university
Other areas of specialty/work
Street address
Kilometre 5 Damghan road, Semnan University of Medical Sciences, Rehabilitation Faculty
City
Semnan
Postal code
Phone
+98 23 1335 4182
Fax
+98 23 1335 4209
Email
aminianfar@razi.tums.ac.iraminfar83@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminian-Far
Position
MS, instructor, Member of the university
Other areas of specialty/work
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, Kilometre 5 Damghan road
City
Semnan
Postal code
Phone
+98 23 1335 4182
Fax
+98 23 1335 4209
Email
aminianfar@razi.tums.ac.iraminfar83@yahoo.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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