Protocol summary

Summary
This clinical trial, non-blind, randomized, two-center, 80 patients randomly assigned to two experimental and control groups of 40 people each, complete demographic and Female Sexual Function Index before intervention and experimental group for 24 sessions over 8 weeks and every 45 to 60 minutes, three days a week as a day and control group routine activities - The exercise in the first four weeks: 1. brisk walking and running (warm-up) 10 minutes 2. The exercise movements 15 Minutes 3. Stretching 10 minutes 4. 10-minute cool-down Exercise in the last four weeks: 1. 15 minutes of brisk walking and jogging 2. The exercise movements 20 Minutes 3. Stretching 15 minutes. 4. 10-minute cool-down After the exercises, both groups were given a month to break their routine activities and follow up on a completing this form will be women's sexual functioning.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060122325N2
Registration date: 2015-06-23, 1394/04/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-23, 1394/04/02
Registrant information
Name
Firoozeh Tadayon Nejad
Name of organization / entity
Abadan Arvand University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613331031
Email address
tadayon.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University Of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aerobic exercise on sexual dysfunction in reproductive ages women
Public title
Effect of aerobic exercise on sexual dysfunction in reproductive ages women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: between the ages of 45-18 years; married, at least two years of their common past; life wife; Sexual Function Index score is less than or equal to 26.5; The minimum read and writeو Exclusion criteria: postmenopausal women; history of chronic medical illnesses and cardiovascular; The history of infertility; The history of hysterectomy; pregnancy or breast-feeding during the study; Drug Addiction; The drugs affect sexual function; mental health problems diagnosed in each couple and individual mobility problems; surgery in the last six months; professional athletes (those who exercise programs for more than 30 minutes a day, 5 to 7 days a week); If a person is missing several sessions are excluded.
Age
From 49 years old to 76 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arvand International University of Medical Sciences
Street address
In front of the International Airport Terminal
City
Abadan
Postal code
00981579461357
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
ajums.REC.1393.434

Health conditions studied

1

Description of health condition studied
female sexual dysfunction
ICD-10 code
Z50.8
ICD-10 code description
care involving use of other rehabilitation procedures

Primary outcomes

1

Description
female sexual function
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Female Sexual Function Index questionnaire based on the score

Secondary outcomes

empty

Intervention groups

1

Description
control group: intervention is not done
Category
Treatment - Other

2

Description
experimental group for 24 sessions over 8 weeks and every 45 to 60 minutes, three days a week as a day of routine exercises The exercise in the first four weeks: 1. brisk walking and running (warm-up) 10 minutes 2. The exercise movements 15 Minutes 3. Stretching 10 minutes 4. 10-minute cool-down Exercise in the last four weeks: 1. 15 minutes of brisk walking and jogging 2. The exercise movements 20 Minutes 3. Stretching 15 minutes. 4. 10-minute cool-down
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center, No. 8 West Ahvaz
Full name of responsible person
Firoozeh Tadayon Nejad, Graduate student Midwifery
Street address
Lashkar circle, Enghelab square
City
Ahvaz

2

Recruitment center
Name of recruitment center
Medical Clinic, 1 West Ahvaz
Full name of responsible person
Firoozeh Tadayon Nejad, Graduate student Midwifery
Street address
South Sheikh Baha Street, Department of Social Welfare
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Golestan Highway
City
Ahvaz
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
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
Ahvaz University of Medical Sciences
Full name of responsible person
Firoozeh Tadayon Nejad
Position
Graduate student Midwifery
Other areas of specialty/work
Street address
Golestan Highway
City
Ahvaz
Postal code
Phone
+98 61 3338 2412
Fax
+98 61 3337 5177
Email
firozehtadayon@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Ahvaz
Postal code
00986135715794
Phone
+98 61336754360
Fax
Email
Mitratadayon2000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Firozeh Tadayon Nejad
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
Ahvaz
Postal code
009861557 5891
Phone
+98 61336754360
Fax
+98 61 3337 5177
Email
Firozehtadayon@gmail.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
Loading...