To determine compliance rate of supervised and home-based exercises during pregnancy and effects of the exercises on some maternal, fetal and neonatal outcomes
Design
In this controlled trial, 150 women will be equally allocated into three parallel groups (supervised, home-based or no intervention groups) using a stratified block randomization with block sizes of 6 and 9. The sequence will be generated using the randomizer program. Consecutively numbered opaque sealed envelopes will be used for the allocation concealment.
Settings and conduct
Eligible pregnant women at gestational age of 12-18 weeks enrolled from the public health centers of Mahabad (Iran) will be randomized into one of the three study groups, after receiving written informed consent and will be followed up until 6 months after delivery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Aged 18-40 years, First to third pregnancy with a single healthy fetus at gestational age of 12-18 weeks, No history of cesarean section or preterm delivery, being literate, Iranian nationality of wife and husband
Exclusion criteria:
Having abnormal uterus, incompetent cervix, or any chronic diseases; Performing regular aerobic exercise; BMI > 35; having suicidal thoughts; unwillingness or inability to attend exercise sessions regularly.
Intervention groups
The first intervention group: supervised exercise
The second intervention group: home-based exercise
The control group: no intervention
Main outcome variables
Compliance rate of the two exercise programs (supervised and home-based) during pregnancy
Depression score, positive and negative affect score, birth weight
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100414003706N37
Registration date:2020-09-07, 1399/06/17
Registration timing:registered_while_recruiting
Last update:2020-09-07, 1399/06/17
Update count:0
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compliance of supervised and home-based exercises during pregnancy and effects of the exercises on some maternal, fetal and neonatal outcomes
Public title
Effect of exercise on pregnancy outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women in the 12th-18th weeks of pregnancy
1st to 3rd pregnancy
Aged 18-40 years
Having a singleton fetus with no known malformation
No previous history of cesarean section
No previous history of premature labour
Be literate
Iranian nationality of wife and husband
Exclusion criteria:
Abnormal (unicorn / septum) uterus
Incompetent cervix
Cardiovascular or respiratory diseases
Uncontrolled type I diabetes
Chronic hypertension
Symptomatic anemia
Uncontrolled thyroid disease
Shortness of breath before exercise and chest pain
Orthopedic limitations
Regular aerobic exercise longer than 30 minutes twice a week or more, during current pregnancy
BMI > 35
Having suicidal thoughts
Unwillingness or inability to attend exercise sessions regularly
Severe back pain
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated into three study groups (supervised or home-based exercise, control with no intervention). Allocation sequence will be generated by a person, not involved in the recruitment and data collection, through individual stratified (based on 1st or 2nd-3rd pregnancy) block randomization with random block sizes of six and nine, and allocation ratio of 1:1:1 using a computer program. The sequence will be concealed using sequentially numbered opaque sealed envelopes.
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 Tabriz University of Medical Sciences
Street address
Third floor, Second centralbuilding, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2020-08-01, 1399/05/11
Ethics committee reference number
IR.TBZMED.REC.1399.481
Health conditions studied
1
Description of health condition studied
Exercise during pregnancy
ICD-10 code
Y93.A3
ICD-10 code description
Activity, aerobic and step exercise
Primary outcomes
1
Description
Compliance rate of the aerobic exercises during pregnancy (average number and duration of exercise in a week)
Timepoint
Two times (1- during 12-18 to 26-28, 2- during 26-28 to 36-38 weeks of pregnancy)
Method of measurement
a diary form
2
Description
Depression Score
Timepoint
At baseline, 26-28 weeks of pregnancy, and 6-8 weeks after delivery
Method of measurement
Edinburgh Depression questionnaire
3
Description
Positive and negative affect Score
Timepoint
At baseline, 26-28 ،36-38 weeks of pregnancy, and 6-8 weeks after delivery
Method of measurement
Positive and Negative Affect Scale (PANAS)
4
Description
Birth weight
Timepoint
After delivery
Method of measurement
Hospital record
Secondary outcomes
1
Description
Anxiety score
Timepoint
At baseline, 26-28 weeks of pregnancy and 6 months after delivery
Method of measurement
Anxiety section of the Depression, Anxiety and Stress Scale (DASS-21)
2
Description
Well-Being Score
Timepoint
At baseline, 26-28 & 36-38 weeks of pregnancy and 6-8 weeks after delivery
Method of measurement
World Health Organization-Five Well-being Index
3
Description
Fatigue score
Timepoint
At baseline, 26-28 weeks of pregnancy, 6-8 weeks and 6 months after delivery
Method of measurement
Multidimensional Assessment of Fatigue scale
4
Description
Sexual function Score
Timepoint
At baseline, 26-28 weeks of pregnancy and 6 months after delivery
Method of measurement
Female sexual function questionnaire (FSFI)
5
Description
Low back pain score
Timepoint
At baseline, 26-38 & 36-38 weeks of pregnancy and 6-8 weeks and 6 months after delivery
Method of measurement
Visual analogue scale (VAS)
6
Description
Urgent and stress urinary incontinence Score
Timepoint
At baseline, 26-28 & 36-38 weeks of pregnancy and 6-8 weeks & 6 months after delivery
Method of measurement
Urinary Incontinence Diagnosis Questionnaire
7
Description
Pregnancy weight gain
Timepoint
During pregnancy
Method of measurement
Using Prenatal record
8
Description
Gestational age
Timepoint
At Birth
Method of measurement
Using date of last menstrual period or ultrasound report and birth date
9
Description
Fear of childbirth
Timepoint
36-38 weeks of pregnancy
Method of measurement
Wijma Delivery Expectancy (W-DEQ)
10
Description
Score of birth satisfaction
Timepoint
6-8 weeks after delivery
Method of measurement
Iranian version of birth satisfaction scale-revised
11
Description
Occurrence of Pregnancy complications (gestational hypertension or pre-eclampsia, gestational diabetes)
Timepoint
26-28 weeks and 36-38 weeks of pregnancy
Method of measurement
Prenatal record
12
Description
Premature or preterm delivery
Timepoint
After delivery
Method of measurement
Using date of last menstrual period or ultrasound report and birth date
13
Description
Cesarean section
Timepoint
After delivery
Method of measurement
Medical record
14
Description
Childbirth trauma
Timepoint
After delivery
Method of measurement
Medical record
15
Description
Postpartum weight loss
Timepoint
6-8 weeks and 6 months after delivery
Method of measurement
Weight scale
16
Description
Apgar score of the first and fifth minutes
Timepoint
First and Fifth minutes after birth
Method of measurement
Hospital record
17
Description
Height and head circumference of infant
Timepoint
After birth
Method of measurement
Hospital record
18
Description
Stress score
Timepoint
At baseline, 26-28 weeks of pregnancy and 6 months after delivery
Method of measurement
Stress section of the Depression, Anxiety, and Stress Scale (DASS-21)
Intervention groups
1
Description
Intervention group1 (supervised exercise): the women will exercise three 30-60 min sessions per week from 12-18th to 38th week of gestational age, adapted to the pregnancy trimesters. One to two of the sessions each week will be under direct guidance of a trained person (in person or in groups of 1-4 persons) while looking at a video tap, and the other one to two sessions will be under indirect supervision (through phone call at the start of each session and 1-2 calls during or end of the sessions).
Category
Lifestyle
2
Description
Intervention group 2 (home-based exercise): following 1-2 educational sessions of the exercises at two time-points (12-18 and 26-28 weeks of gestational age), the video exercise tap will be given to the participants and they will be instructed to adhere to the prescribed aerobic exercise program and have regular exercise (at least three times a week, 30-60 min/session) at home, they will be reminded by sending a short message at the start of each session) and their performance will be monitored via phone calls once a week. All necessary instructions and precautions will be provided to the intervention groups both verbally and in written.
Category
Lifestyle
3
Description
Control group: no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahabad Public Health Centers
Full name of responsible person
Dr Engineer Qasem Amini
Street address
Tohid
City
Mahabad
Province
West Azarbaijan
Postal code
5915913174
Phone
+98 44 4244 2008
Fax
+98 44 4244 0099
Email
amini.ghassem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Research department, Third floor, Central Building number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 1334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://researchvice.tbzmed.ac.ir
Grant name
Special Grant for 20% active researchers in the University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Tabriz University of Medical Sciences
Full name of responsible person
Afsaneh veisy
Position
PhD student in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati Ave., Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5137975846
Phone
+98 41 3479 6770
Email
a.veisy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad- Alizadeh - charandabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Ave., Tabriz.
City
TAbriz
Province
East Azarbaijan
Postal code
5137975846
Phone
+98 41 3479 6770
Email
alizades@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5137975846
Phone
+98 41 3479 6770
Email
alizades@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All deidentified IPD can be shared
When the data will become available and for how long
Starting soon after publication of the study results for ten years.
To whom data/document is available
Data will be available for researchers working in academic institutions, as well as to chief editor and reviewers of the submitted manuscript.
Under which criteria data/document could be used
The data will be available to researchers upon request and submission of the proposal to perform meta-analysis using IPD. Also, in exceptional cases, data will be made available to chief-editor of the journals for checking.
From where data/document is obtainable
Refer to the email addresses (alizades@tbzmed.ac.ir, a.veisy@yahoo.com)
What processes are involved for a request to access data/document
The requests should be sent by email and data will be available within two week.