The effect of aquatic exercise on body composition, blood lipids and thyroid hormone levels in pregnant women.
Design
The clinical trial with a randomized control group, on 30 patients, was used for randomization using the block of six method.
Settings and conduct
The samples were selected from health centers in Isfahan city. The intervention group starts training in water from 20 to 34 weeks of pregnancy. People in the intervention group during pregnancy perform water sports with moderate intensity 3 times a week for 40 minutes in the indoor pool of Isfahan University under the supervision of a trainer and a midwife. The control group will receive usual pregnancy care and no exercise intervention. A researcher-made questionnaire will be used to measure pregnancy outcomes.
Participants/Inclusion and exclusion criteria
Inclusion criteria at 20-34 weeks of pregnancy and consent to participate in the study. Exclusion criteria: diseases such as: blood pressure, heart problems, absence of more than 2 sessions in sports programs, lack of satisfaction with participating in the research.
Intervention groups
The intervention group starts exercise from 20-34 weeks of pregnancy and they do aquatic exercise in the indoor swimming pool of Isfahan University under the supervision of a trainer and midwife during pregnancy. The control group will receive routine care during pregnancy and will not have exercise intervention.
Main outcome variables
Body composition, blood lipids and thyroid hormone levels in pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230819059185N1
Registration date:2023-09-24, 1402/07/02
Registration timing:prospective
Last update:2023-09-24, 1402/07/02
Update count:0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Nastaran Motavali
Name of organization / entity
The university of Esfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 4536 4231
Email address
motavalinb199@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-30, 1402/08/08
Expected recruitment end date
2023-11-29, 1402/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of aquatic exercise on body composition, blood lipids and thyroid hormone levels in pregnant women
Public title
The effect of aquatic exercise in water on thyroid hormone
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
20-34 weeks of pregnancy
Consent to participate in the study
Exclusion criteria:
Diseases such as: blood pressure, heart problems, absence of more than 2 sessions in exercise programs
Dissatisfaction with participating in the research
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
15
Blood fat levels, body composition and thyroid hormone.
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be in the form of six-block randomization. The current research will be conducted as a clinical trial. Pregnant women will be randomly assigned to the intervention and control groups using blocks of six. The research environment will be Isfahan University.
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
Ethical Committee of Isfahan University
Street address
University of Isfahan, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
ٰIR.UI.REC.1402.058
Health conditions studied
1
Description of health condition studied
Thyroid hormone, blood lipid levels, body composition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body composition
Timepoint
Before the start of the intervention and 8 weeks after the intervention
Method of measurement
Body composition analysis device
2
Description
Blood lipid levels
Timepoint
Before the start of the intervention and 8 weeks after the intervention
Method of measurement
Serum measurement
3
Description
Thyroid hormone
Timepoint
Before the start of the intervention and 8 weeks after the intervention
Method of measurement
Serum measurement
Secondary outcomes
empty
Intervention groups
1
Description
The number of people in the intervention group is 15 people. The intervention group starts training from 20 to 34 weeks of pregnancy. People in the intervention group during pregnancy perform water sports for 8 weeks, 3 sessions a week and each session is 40 minutes with moderate intensity in the indoor swimming pool of Isfahan University under the supervision of a trainer and a midwife. The time of each session includes: impact position, warm-up phase (5 minutes), aerobic phase (20 minutes), strength phase (10 minutes) and the last final phase of returning to the relaxation state (5 minutes) in which relaxation techniques and Muscles are stretched.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Deputy Health Center, Kamal St
Full name of responsible person
Mehdi Kargarfard
Street address
Isfahan Azadi Square, University of Isfahan, Faculty of Sport Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3668 7572
Fax
+98 31 3668 7571
Email
m.kargarfard@spr.ui.ac.ir
Web page address
https://spr.ui.ac.ir/m.kargarfard
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Sports Sciences and Physical Education, University of Isfahan
Full name of responsible person
Isfahan University Research Assistant
Street address
University of Esfahan, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Fax
+98 31 3793 2572
Email
m.kargarfard@spr.ui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Sports Sciences and Physical Education, University of Isfahan
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
The university of Isfahan
Full name of responsible person
Mehdi Kargarfard
Position
Faculty at University of Isfahan
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Mehdi Kargarfard Professor, University of Isfahan Faculty of Sport Sciences Department of Exercise Physiology Hezar Jerib Street, P.O. Box 81746-7344 Ph: +98 31 37934282 Fax: +98 31 36687572 Email: m.kargarfard@spr.ui.ac.ir
City
Isfahan
Province
Isfehan
Postal code
81746-7344
Phone
+98 31 3668 7572
Fax
+98 31 3668 7572
Email
m.kargarfard@spr.ac.ir
Web page address
https://spr.ui.ac.ir/m.kargarfard
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Kargarfad
Position
Faculty at University
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Mehdi Kargarfard Professor, University of Isfahan Faculty of Sport Sciences Department of Exercise Physiology Hezar Jerib Street, P.O. Box 81746-7344 Ph: +98 31 37934282 Fax: +98 31 36687572 Email: m.kargarfard@spr.ui.ac.ir
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3668 7572
Fax
+98 31 3668 7396
Email
m.kargarfard@spr.ui.ac.ir
Web page address
https://spr.ui.ac.ir/m.kargarfard
Person responsible for updating data
Contact
Name of organization / entity
The university of Esfahan
Full name of responsible person
Nastaran Motavali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
University of Esfahan, Azadi Square, Esfahan
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Fax
+98 31 3668 7396
Email
m.kargarfard@spr.ui.ac.ir
Web page address
https://spr.ui.ac.ir/m.kargarfard
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD