The effect of eight weeks of aquatic training on metabolic factors, body composition, sleep quality and back pain in pregnant women with gestinal diabetes mellitus
Gestational diabetes is a common complication of pregnancy in which hyperglycemia occurs spontaneously during pregnancy. the importance of sports activities is being studied by researchers.
Studies have shown that physical activity in pregnancy has effective physiological and metabolic effects and improves insulin resistance. Therefore, in the present study, the effect of performing sports activities in water on body composition and glycemic indices was investigated.
Design
The research design is practical and is done with a pre-test-post-test design that will last for eight weeks. As a sample, 30 people are selected according to the criteria for entering the research. Then, they are randomly divided into two groups of training in water and control. The water training program is three sessions a week and the control group follow their daily activities. Body composition indices and blood samples are taken before and after the implementation of the plan.
Settings and conduct
Isfahan University-Faculty of Sports Sciences
Participants/Inclusion and exclusion criteria
All of them should have general health and their gestational diabetes should be confirmed by a doctor.All participants must be between the ages of 20 and 40.All participants followed a special diet.All participants did not participate in sports activities during the last six months.All participants do not have a history of premature birth.All participants do not need prenatal care.
Absent more than 2 to 5 training sessions alternately during the training period.Musculoskeletal injury occurs during the exercise program.
Use other sports supplements.
Intervention groups
Aqua training group
Control group
Main outcome variables
Body weight
Body mass index
Fat percentage
Fasting glucose
Blood insulin
Insulin resistance
Glycosylated hemoglobin
Sleep quality
Back pain
Pain in the pelvic girdle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230920059475N1
Registration date:2023-10-24, 1402/08/02
Registration timing:retrospective
Last update:2023-10-24, 1402/08/02
Update count:0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Shahla Lessani
Name of organization / entity
The University of Esfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 4268 7109
Email address
shahlalessani@spr.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of aquatic training on metabolic factors, body composition, sleep quality and back pain in pregnant women with gestinal diabetes mellitus
Public title
The effect of eight weeks of aquatic training on metabolic factors, body composition, sleep quality and back pain in pregnant women with gestinal diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
They all have general health and their gestational diabetes will be confirmed by a doctor.
All participants are between the ages of 20 and 40.
All participants follow their normal diet.
All participants have not participated in sports activities in the last six months.
All participants do not have a history of premature birth.
All participants do not need prenatal care.
Exclusion criteria:
Absent more than 2 to 5 training sessions alternately during the training period.
Musculoskeletal injury occurs during the exercise program
Use other sports supplements.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
The samples will be determined by the random block method with 4-blocks and using the random numbers table of Allocation Random software. Blocking and allocation sequence for concealment will be done by a person not involved in the research.
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
National Committee on Ethics in Biomedical Research
Street address
Central Building of Ministry of Health and Medical Education,simaye iran street, Qods Township (West), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2023-09-26, 1402/07/04
Ethics committee reference number
59475
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
024.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Weight measurement
Timepoint
It is measured before and after eight weeks.
Method of measurement
Using SECA scales made in Germany.
2
Description
Body mass index measurement
Timepoint
It is measured before and after eight weeks.
Method of measurement
Height to weight ratio
3
Description
Fat percent measurement
Timepoint
It is measured before and after eight weeks.
Method of measurement
Body composition device
4
Description
Fasting blood glucose measurement
Timepoint
It is measured before and after eight weeks.
Method of measurement
Blood sampling is taken by expert in laboratory.
5
Description
Blood insulin measurement
Timepoint
It is measured before and after eight weeks.
Method of measurement
Blood sampling is taken by expert in laboratory.
6
Description
Insulin resistance measurement
Timepoint
It is measured before and after eight weeks.
Method of measurement
Blood sampling is taken by expert in laboratory.
7
Description
Measurement of glycosylated hemoglobin
Timepoint
It is measured before and after eight weeks.
Method of measurement
Blood sampling is taken by expert in laboratory.
8
Description
Measurement of sleep quality
Timepoint
It is measured before and after eight weeks.
Method of measurement
Pittsburgh Sleep Quality Questionnaire
9
Description
Back pain measurement
Timepoint
It is measured before and after eight weeks.
Method of measurement
OSWESTRY DISABILITY INDEX Questionnaire
10
Description
Measurement of pelvic girdle pain
Timepoint
It is measured before and after eight weeks.
Method of measurement
Pelvic Girdle Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: There are three sessions per week of the training program in the water, which lasts for 75 minutes. The exercise program is carried out under the supervision of a hydrotherapy specialist.
Category
Other
2
Description
Control group: They do not have any sports activities and only do daily activities.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan university
Full name of responsible person
Shahla Lessani
Street address
Faculty of Sports Sciences - Isfahan University - Hazarjarib Street - Isfahan City - Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
shahlalessani@spr.ui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hadi Amiri
Street address
Faculty of Sports Sciences - Isfahan University - Hezar Jarib Street - Isfahan City - Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
shahlalessani@spr.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Isfahan
Proportion provided by this source
50
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 Kargari Fard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
Faculty of Sports Sciences - Isfahan University - Hazarjarib Street - Isfahan City - Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
m.kargarfard@spr.ui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mehdi Kargari Fard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Faculty of Sports Sciences - Isfahan University - Hazarjarib Street - Isfahan City - Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
m.kargarfard@spr.ui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mehdi Kargari Fard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physioligy
Street address
Faculty of Sports Sciences - Isfahan University - Hazarjarib Street - Isfahan City - Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
m.kargarfard@spr.ui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Title and more details about the data/document
Usage data is shared after being de-identified.
When the data will become available and for how long
The access period starts 6 months after the publication of the results
To whom data/document is available
Community members, clinical experts and sports science researchers
Under which criteria data/document could be used
The results obtained using statistical analysis show the effectiveness of the exercise program and only pregnant women with diabetes are allowed to use this exercise protocol.
What processes are involved for a request to access data/document
The implementation of the research design lasts for 10 weeks, the first and tenth weeks are related to the measurement of the study variables, and the exercise program is eight weeks, with three sessions per week.