Determining the effect of exercise training on fatigue during pregnancy: a randomized controlled trial
Design
Clinical trial with a control group, with parallel groups, single blind, randomized, on 68 pregnant mothers. A table of random numbers is used for randomization.
Settings and conduct
The samples of this study will be randomly divided into two groups after selection. In the intervention group, in addition to exercising in class, they exercise at home at least four times a week, for 45 minutes each time. The training protocol includes warming up for 15 minutes, stretching exercises for 15 minutes and flexibility exercises for 15 minutes.The entire intervention period for each mother lasts eight weeks. Group B samples only do sports exercises in class and do not repeat sports at home.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with a gestational age of 20 to 30 weeks; Having a live and healthy fetus; Having a singleton pregnancy; The tendency of the research units.
Exclusion criteria: Absence of more than two sessions in childbirth preparation classes; Prohibition of exercise during pregnancy according to consultation with obstetrician and gynecologist.
Intervention groups
In addition to participating in eight childbirth preparation class sessions and doing pregnancy exercises in the last half hour of the class, the intervention group does exercises at home at least four times a week for 45 minutes each time. The control group samples only In class, they do sports exercises and do not repeat sports at home.
Main outcome variables
Fatigue during pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038783N9
Registration date:2024-04-19, 1403/01/31
Registration timing:prospective
Last update:2024-04-19, 1403/01/31
Update count:0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
Fereshteh Behmanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 0504
Email address
f.behmanesh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-03, 1403/02/14
Expected recruitment end date
2026-06-20, 1405/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of exercise on fatigue during pregnancy: A randomized controlled trial
Public title
The effect of exercise on fatigue during pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a gestational age of 20 to 30 weeks
Having a live and healthy fetus
Having a singleton pregnancy
The willingness of the research units
Exclusion criteria:
Absence of more than two sessions in childbirth preparation classes
Prohibition of exercise during pregnancy according to consultation with obstetrician and gynecologist
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
After selection, the samples are randomly divided into two groups using a table of random numbers.The block randomization method with 12 blocks will be utilized. Participants will be allocated to one of two groups in a 1:1 ratio following the block randomization protocol (generated by Random Allocation Software).
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
Health Research Institute- Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2024-02-18, 1402/11/29
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.174
Health conditions studied
1
Description of health condition studied
Normal pregnancy
ICD-10 code
Z34
ICD-10 code description
Encounter for supervision of normal pregnancy
Primary outcomes
1
Description
Fatigue during pregnancy
Timepoint
Before the start of the study and after 8 weeks from the start of the study
Intervention group: They will have eight weeks of exercise training in the preparation class for childbirth and at home (once in the class and at least four times at home for 45 minutes).
Category
Lifestyle
2
Description
Control group: The control group samples only In class, they do sports exercises and do not repeat sports at home.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Yahya Nejad Hospital
Full name of responsible person
Fereshteh Behmanesh
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+98 11 3219 9594
Email
f.behmanesh2015@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+98 11 3219 9594
Email
ramazan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+98 11 3219 9594
Email
f.behmanesh2015@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+98 11 3219 9594
Email
f.behmanesh2015@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fereshteh Behmanesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4718758563
Phone
+98 11 3219 9594
Email
f.behmanesh2015@gmail.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