Protocol summary

Summary
The purpose of this study was to evaluate the effects of a "Home Base Exercise" plan on metabolic and hormonal parameters in patients with PCOs. Forty PCO patients of Gynecologic or Endocrinologic clinic were assigned to intervention or control group based on a block randomization method. A "Home Base Exercise" plan including 30 minutes of aerobic and resistive exercises 3 times a week was given to patients in the intervention group; and no exercise program to the control group. In both group, the routine treatments (according to Gynecologic or Endocrinologic clinic) and regular diet were continued and they were followed for 3 months. Age, Weight, Body Mass Index (BMI), Blood Pressure, Abdominal Circumference and Abdominal: gluteal circumference ratio was measured at the beginning of the study. Serum concentration of TSH, Prolactin, 17-Hydroxy Progestrone (17-OHP), Testosterone, FBS, Insulin, TG, Cholesterol, HDLc, and hsCRP were measured at the beginning of the study and at the end of the 3 month period of exercise program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902073819N1
Registration date: 2009-12-15, 1388/09/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-12-15, 1388/09/24
Registrant information
Name
Shahrzad Khosravi
Name of organization / entity
Sport medicine Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 0227
Email address
sh_khosravi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-12-15, 1388/09/24
Expected recruitment end date
2010-06-15, 1389/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An evaluation of the efficacy of a "Home Base Exercise" program in clinical signs and hormonal and metabolic profile in patients with Poly Cystic Ovarian Syndrome (PCOS); a Randomized Clinical Trial
Public title
An evaluation of the efficacy of a "Home Base Exercise" program in clinical signs and hormonal and metabolic profile in patients with Poly Cystic Ovarian Syndrome (PCOS); a Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Definite diagnosis of poly cystic ovary Exclusion criteria: BMI>35kg/m2, Cancer, Metabolic Diseases (FBS>126mg/dl, Endocrine diseases, Hepatic, renal or cardiovascular diseases, Drugs (OCP, Glucocorticoids, Anti-androgens, Anti-Diabetics), Cigarette smoking, Alcohol consumption, pregnancy and failure to follow-up
Age
From 15 years old to 45 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2007-02-01, 1385/11/12
Ethics committee reference number
87-04-53-8006

Health conditions studied

1

Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome Stein-Leventhal syndrome

Primary outcomes

1

Description
17(oh)Progestron
Timepoint
before and 3 mounth after intervention
Method of measurement
radioimmunoassays (RIA)

2

Description
change in weight
Timepoint
before and 3 mounth after intervention
Method of measurement
weight calculator

3

Description
BMI
Timepoint
before and 3 mounth after intervention
Method of measurement
weight/height* height

4

Description
waist to hip ratio
Timepoint
before and 3 mounth after intervention
Method of measurement
waist to hip ratio

5

Description
Blood pressure
Timepoint
before and 3 mounth after intervention
Method of measurement
BP calculator

6

Description
Prolactin
Timepoint
before and 3 mounth after intervention
Method of measurement
radioimmuno assay

7

Description
TG
Timepoint
before and 3 mounth after intervention
Method of measurement
commerial kits

8

Description
FBS
Timepoint
before and 3 mounth after intervention
Method of measurement
Glucose oxidase method

9

Description
Insulin
Timepoint
befor intervention,3 mounth
Method of measurement
immunoassay enzyme

10

Description
Insulin resistance
Timepoint
before and 3 mounth after intervention
Method of measurement
FBS/INsulin

11

Description
HDL
Timepoint
before and 3 mounth after intervention
Method of measurement
commercial kits

12

Description
Testostrone
Timepoint
before and 3 mounth after intervention
Method of measurement
radioimmunoassays (RIA)

13

Description
TSH
Timepoint
before and 3 mounth after intervention
Method of measurement
radioimmunoassays (RIA)

14

Description
Cholestrol
Timepoint
before and 3 mounth after intervention
Method of measurement
commercial kits

15

Description
hsCRP
Timepoint
before and 3 mounth after intervention
Method of measurement
commercial kits

Secondary outcomes

1

Description
Cardiovascular effect
Timepoint
before intervention and 3 months after intervention
Method of measurement
hsCRP

Intervention groups

1

Description
Home Base Exercise program / Aerobic (at least 5 days, 30 minites each) and Resistance exercise (3 days), for 3 months
Category
Lifestyle

2

Description
No exercise in control group, general consultation only
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali e asr reproductive health research center, Imam khomaini hospital
Full name of responsible person
Dr. Shahrzad Khosravi
Street address
Imam Khomaini hospital, Tehran, Iran,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Vasheghani Farahani
Street address
Vice Chancellery For Reasearch, Tehran University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Khosravi
Position
Sport Medicine Assistant
Other areas of specialty/work
Street address
Sport Medicine Research Center
City
Tehran
Postal code
00982188630227
Phone
+98 21 8863 0227
Fax
Email
sh_khosravi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Farzane Vasheghani Farahani
Position
Gyneycologist
Other areas of specialty/work
Street address
Sport medicine research center, Jalal al ahmad St.
City
Tehran
Postal code
Phone
+98 21 8863 0227
Fax
Email
farzanehvf@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Khosravi
Position
Sport Medicine Assistant
Other areas of specialty/work
Street address
Sport Medicine Research Center
City
Tehran
Postal code
Phone
+98 912 226 4882
Fax
Email
sh_khosravi@razi.tums.ac.ir
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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