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Effect of eight weeks of combined exercises (High intensity interval training and Yuga) on the serum Estradiol and sexual function in postpartum

Protocol summary

Study aim
the effect of High intensity interval training and yoga on the serum levels of Estradiol and sexual function in postpartum women
Design
Two arm parallel group randomized trial and outcome assessment.
Settings and conduct
pregnant mothers who are under vision of health care centers in Bojnourd city with vaginal delivery who are dissatisfied with sexual function compared to pre-pregnancy and delivery.after contacting midwifery clinics, 20 individuals are selected and randomly divided into two groups and familiarization with the research protocol and their consent.
Participants/Inclusion and exclusion criteria
Being primiparous or second-born, being in lactation period, having no specific illness and having a healthy baby. no complications of preterm labor, postpartum depression, no use of vitamin E, no psychotropic drugs, no smoking and alcohol or drugs, no limitation to engage in physical activity and loosing more than three sessions. Lack of regular postpartum exercise, normal pre-pregnancy BMI, score of less than 26.5 in the sexual function.
Intervention groups
This study is done on the two experimental and control groups. In EG, each session included 5 to 10 minutes of warm-up program including stretching exercises and then 15-20 minutes of yoga exercises to strengthen the lower limbs and pelvis; as well as several jumping movements. And the explosion is performed optimally for a 2-5 minute increase in heart rate for running (HIIT) training and in the final stage a cooling program is performed for 5-10 minutes with yoga relaxation training. The control group also benefit from routine care.
Main outcome variables
serum Estradiol ; sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170501033743N3
Registration date: 2021-10-31, 1400/08/09
Registration timing: retrospective

Last update: 2021-10-31, 1400/08/09
Update count: 0
Registration date
2021-10-31, 1400/08/09
Registrant information
Name
Najmeh Alsadat Shojaeian
Name of organization / entity
Azad University of Bojnourd
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 1594
Email address
shojaeian@bojnourdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
2018-04-19, 1397/01/30
Scientific title
Effect of eight weeks of combined exercises (High intensity interval training and Yuga) on the serum Estradiol and sexual function in postpartum
Public title
Effect of physical activity on postpartum health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being primiparous or second-born Being in lactation (three to four months after childbirth) To have a healthy baby No complications of depression To have a spouse There were also no complications of preterm labor, high blood hypertension in pregnancy, history of liver, kidney, heart, diabetes, inflammatory disease, thrombotic or cerebrovascular diseases, mental illness, hyperlipidemia, atherometriosis, history of chemotherapy, or radiation therapy For the past six months, no hormone replacement therapy, no use of vitamin E, no psychotropic drugs and other effective herbal or chemical drugs No smoking and alcohol or drugs Normal pre-pregnancy BMI
Exclusion criteria:
To have any illness that prevented them from engaging in physical activity To loos the intervention more than three sessions To do the regular exercise in postpartum To gain a score higher than 26.5 based on the sexual function questionnaire. To have any emotional stress such as the death of relatives To decide not to continue in research and/or withdrew her consent
Age
From 21 years old to 37 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method was used. This method makes the type of intervention assigned to each group completely unpredictable. Therefore, 20 healthy eligible women were divided into control and intervention groups. Random allocation software was used to generate random sequences. In this method, the computer randomly generated the letters A and B. The recipients of letter A joined the intervention group and letter B joined the control group and the allocation ratio of individuals in each group was equal. According to the names of the participants in the study, after obtaining a random letter by the computer, each letter was assigned to the list of participants in the study and the presence of individuals in the groups was determined. For example, the first letter obtained was given to the first person on the list, and this allocation was applied to the whole list.
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
Ethics committee of Islamic Azad university of Bojnourd
Street address
Daneshgah BLV, Islamic Azad university of Bojnourd
City
Bojnourd
Province
North Khorasan
Postal code
97796- 94176
Approval date
2017-11-03, 1396/08/12
Ethics committee reference number
34/24ک1234

Health conditions studied

1

Description of health condition studied
Effect of physical activities on Estradiol serum and sexual function
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Assessment of sexual function in postpartum
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The main variable of the study was determination of serum estradiol level. Blood samples from the third to fifth days of menstruation were collected after two months of exercise for the experimental group and the control group by a lab expert through a vein of left hand (05 ml) in a sitting position and they were tested by ELISA method.
Timepoint
After two months of exercise and between third to fifth days of menstruation
Method of measurement
Blood samples from the vein of left hand

2

Description
Before and after two months of intervention, Sexual Function and Sexual Schema Questionnaire(FSFI) was used. This questionnaire measures women's sexual function in six areas including desire, mental stimulation, humidity, orgasm, satisfaction, sexual pain. The questionnaire was developed by Rosen et al. (2000). The FSFI Women's Sexual Function Index in Iran was standardized by Mohammadi and its consistency was obtained by using Cronbach's alpha coefficient (r = 0.85) as well as cutoff point for whole scale and subscales.
Timepoint
Before and after the intervention was measured by a questionnaire.
Method of measurement
Sexual Function and Sexual Schema Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Each session included 5 to 10 minutes of general warm-up program including stretching exercises and then 15-20 minutes of yoga exercises to strengthen and stretch muscles and body systems, especially the lower limbs and pelvis; as well as several jumping movements. And the explosion was performed optimally for a 2-5 minute increase in heart rate for running (HIIT) training and in the final stage a cooling program was performed for 5-10 minutes with yoga relaxation training.The HIIT exercise was performed so that the subjects ran at a maximum speed of 20 m from the starting point (cone number 1) to cone number two (path A), then turned in the opposite direction, They ran 20 m to cone No. 3 (track B). Finally, return again and run to the starting point (cone number 1) at maximum speed (route C) to complete the 40m distance. Subjects continued this process at maximum speed until the 30-second exercise period was completed. After 30 seconds of rest, the exercise was repeated. Exercise progression was increased by increasing the number of 30-second repetitions from 4 times in the first and second weeks, to 5 times in the third and fourth weeks, and 6 times in the fifth and sixth weeks, and 7 times in the seventh and eighth weeks
Category
Other

2

Description
Control group: During the 8 weeks of training protocol, the subjects in the control group did not have any regular exercise.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Homa Rahmat Pregnancy Care Center
Full name of responsible person
Mrs Yazdizadeh
Street address
Vedad Street - Doctors Complex
City
بجنورد
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6982
Email
nshojaeian@yahoo.com

2

Recruitment center
Name of recruitment center
Bentolhoda Hospital
Full name of responsible person
Dr Mafinejad
Street address
Honar Street- Bentolhoda Hospital
City
بجنورد
Province
North Khorasan
Postal code
9414951156
Phone
+98 58 4223 6551
Email
shahinmaf@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Zamirian
Street address
Daneshgah St - Azad University - Department of Sport Sciences
City
بجنورد
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6983
Email
nshojaeian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Bojnourd
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Tahereh Shokrani
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Daneshgah st, Islamic Azad University of Bojnourd, Sport science department
City
بجنورد
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6985
Email
nshojaeian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Najmeh-Alsadat Shojaeian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor behaviour- Motor Development
Street address
Daneshgah St, Islamic Azad University of Bojnourd - Department of Sport Sciences
City
Bojnourd
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6985
Email
nshojaeian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Najmeh-Alsadat Shojaeian
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Motor Behavior
Street address
Daneshgah St, Islamic Azad University of Bojnourd - Department of Sport Sciences
City
بجنورد
Province
North Khorasan
Postal code
9417697796
Phone
+98 58 3229 6982
Email
nshojaeian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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