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The effect of eight weeks combined resistance and endurance exercise training on serum estradiol leveland the sleep quality in menopausal women

Protocol summary

Summary
Background: Menopause, an expected event in a woman’s life, is associated with multiple symptoms including vasomotor symptoms, vaginal symptoms, urinary incontinence, sexual dysfunction, and trouble sleeping. The aim of this study was to evaluate the effect of eight weeks of combined resistance and endurance training on the serum estradiol level and sleep quality in menopausal women. Materials and Methods :22 healthy postmenopausal women participated in the study and they were randomly classified into tow groups: control group (n=10, age 56.9±4.9 years) and combined training (n=12, age 54.8±4.7 years) . combined training was carried out for 8 weeks, 3 sessions per week. Duration of each session was 90 minutes. weight, body mass index(BMI), percent body fat, cardiorespiratory fitness and serum estradiol level and Pittsburgh Sleep questionnaire was measured at the beginning and end of exercise period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122222498N5
Registration date: 2016-07-21, 1395/04/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-21, 1395/04/31
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Rasht
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks combined resistance and endurance exercise training on serum estradiol leveland the sleep quality in menopausal women
Public title
The effect of eight weeks combined resistance and endurance exercise training on serum estradiol leveland the sleep quality in menopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: history of drug use have been present for at least one year from the last menstrual period, subjects were under 30 minutes of physical activity per week Exclusion criteria: in practice groups, participants had been missing no more than two sessions, the control group; in did not participate in any exercise program.
Age
From 50 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University of Rasht
Street address
Lakan BVL
City
Rasht
Postal code
3516-41335
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
11721404922052

Health conditions studied

1

Description of health condition studied
Menopausal
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Estradiol
Timepoint
8 weeks after Excercise Training
Method of measurement
Blood in the laboratory

Secondary outcomes

1

Description
Pittsburgh Sleep questionnaire
Timepoint
8 weeks after Excercise Training
Method of measurement
va Pittsburgh Sleep questionnaire

Intervention groups

1

Description
Endurance_Resistance Training in training group
Category
Other

2

Description
The control group had no activity
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mosque Moalem Blvd
Full name of responsible person
Malahat Moazzeni
Street address
Faz1, Moalem Blvd
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Islamic Azad, Rasht Branch
Full name of responsible person
Ramin Shabani
Street address
Lakan BVL
City
Rasht
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, University of Islamic Azad, Rasht Branch
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
Islamic Azad university of Rasht
Full name of responsible person
Malahat moazzeni
Position
Associate Professor
Other areas of specialty/work
Street address
Lakan BVL
City
Rasht
Postal code
Phone
+33 430503
Fax
Email
Malahat.moazeni@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Rasht
Full name of responsible person
Ramin Shabani
Position
Associate Professor
Other areas of specialty/work
Street address
Lakan BVL
City
Rasht
Postal code
Phone
+33 430503
Fax
shabani@iaurasht.ac.ir
Email
shabani@iaurasht.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Rasht
Full name of responsible person
Malahat Moazzeni
Position
MSc
Other areas of specialty/work
Street address
Lakan BVL
City
Rasht
Postal code
Phone
00
Fax
Email
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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