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The effect of aerobic exercise on neonatal health indicators of nulliparous pregnant women with poor sleep quality

Protocol summary

Study aim
The effect of aerobic exercise on neonatal health indicators of nulliparous pregnant women with poor sleep quality
Design
Clinical trials with control group, with parallel groups, Randomized, single center trial. Sample size (2 groups of 30 control and intervention).
Settings and conduct
Damghan Health Center Questionnaire, Apgar score at birth, height and head are measured by tape measure, weight by scales at birth
Participants/Inclusion and exclusion criteria
Pregnant women 18 to 35 years old, 24 to 40 weeks pregnant, normal bmi, singleton, healthy water bag, nulliparous, moderate socioeconomic status, Iranian citizenship, willing to cooperate in the project, no medical prohibition to do medical and sports activities, Dissatisfaction with research, non-consumption of alcohol, tobacco and drugs, lack of kidney, lung, cardiovascular, hepatitis, frequency and dietary diversity
Intervention groups
Intervention group: In this group, according to the protocol, aerobic exercises include warming up, followed by step aerobic exercise for 30 to 45 minutes (three days a week) and each time for 10 weeks. Control group: Only for comparison with intervention group, no treatment is performed.
Main outcome variables
Neonatal health indices of transcripts, including Apgar score, head circumference, height, weight

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210319050744N1
Registration date: 2021-05-31, 1400/03/10
Registration timing: registered_while_recruiting

Last update: 2021-05-31, 1400/03/10
Update count: 0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
ali niknaiea
Name of organization / entity
Semnan University
Country
Iran (Islamic Republic of)
Phone
+98 23 3522 4553
Email address
aliniknaiea@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic exercise on neonatal health indicators of nulliparous pregnant women with poor sleep quality
Public title
The effect of aerobic exercise on newborn children health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 18 to 35 years old They are 24 to 40 weeks pregnant They have a normal body mass index (BMI) They have Iranian citizenship They have almost the same frequency and variety of food They have an average social and economic status Pregnant women are primiparous Have the amount of daily physical activity (light activity)
Exclusion criteria:
Pregnant women who have a medical ban on physical activity They are not satisfied to participate in the research They have kidney, heart, vascular and hepatitis diseases They consume alcohol, tobacco and drugs
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple sequential allocation in one of the two study groups by help of sealed envelope and receive the intervention of the same group. The unit of randomization is patient. Sealed envelopes are delivered to expert. With each patient's visit, one of the envelopes is randomly selected by the patients and determines the study group. The stratification approach is not used.
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
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.SEMUMS.REC.1399.341

Health conditions studied

1

Description of health condition studied
The effect of aerobic exercise on newborn children health indicators with nulliparous pregnant mothers with poor sleep quality.
ICD-10 code
F51.12
ICD-10 code description
Insufficient sleep syndrome

Primary outcomes

1

Description
The effect of aerobic exercise on neonatal health indices of nulliparous pregnant women
Timepoint
3 days a week for 30 to 45 minutes for 10 weeks
Method of measurement
Exercise Protocol (Pedometer) by Pregnancy Physical Activity Assessment Questionnaire

2

Description
Petersburg Sleep Quality Questionnaire
Timepoint
It is measured at least twice and three times if possible
Method of measurement
Petersburg Sleep Questionnaire

Secondary outcomes

1

Description
Remember the 24-hour feed of the pregnant mother
Timepoint
Daily
Method of measurement
24-hour food recall (to control nutrition, frequency and dietary diversity)

Intervention groups

1

Description
Intervention group: In this group, according to the protocol, aerobic exercises include warming up, followed by step aerobic exercise for 30 to 45 minutes (three days a week) and each time for 10 weeks.
Category
Prevention

2

Description
Control group: Only for comparison with intervention group, no treatment is performed.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Damghan Health Center
Full name of responsible person
Dr.Behrad Pourmohammadi
Street address
Shahid Fallahi Street, next to the Civil Registry Office
City
Damghan
Province
Semnan
Postal code
3671678811
Phone
+98 23 3523 5613
Email
president-office@semums.ac.ir
Web page address
https://semums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Personal
Full name of responsible person
Ali Niknaei
Street address
Yas 29, North Gol Yas St, Golestan Town
City
Damghan
Province
Semnan
Postal code
3671635745
Phone
+98 23 3522 4553
Email
aliniknaiea@semnan.ac.ir
Grant name
None
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
none
Proportion provided by this source
1
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Education
Full name of responsible person
Ali Niknaei
Position
Secretary of Physical Education
Latest degree
Bachelor
Other areas of specialty/work
Physical Education and Sports Science
Street address
North of Yas 49, Gol Yas street, Golestan town
City
Damghan
Province
Semnan
Postal code
3671635765
Phone
+98 23 3522 4553
Email
aliniknaiea@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University
Full name of responsible person
Fatemeh Rezaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
PhD in Motor Behavior
Street address
Opposite Sokan Park, Campus No. 1, Semnan University Central Organization
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3153 0000
Email
frezaee39@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Education
Full name of responsible person
Ali Niknaei
Position
Secretary of Physical Education
Latest degree
Bachelor
Other areas of specialty/work
Physical Education and Sports Science
Street address
North of Yas 49, Gol Yas street, Golestan town
City
Damghan
Province
Semnan
Postal code
3671635765
Phone
+98 23 3522 4553
Email
aliniknaiea@semnan.ac.ir

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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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