The effect of aerobic ,resistant ,and combined training on maternal blood pressure and fetal and maternal heart rate variability is studied.
Design
4 arm parallel group randomized trial with blinded outcome assessment and 10 person in each group is done.
Settings and conduct
The research is done in Shahid Akbarabadi hospital in Tehran.Low risk pregnant women are assessed with wellbeing checklist ,physical activity, and nutrition questionnaires. َAlso their anthropometric criteria are assessed .All assessments are done at 8-12 AM. Electrocardiogram and NST are done for all subjects at gestational age of 24-26 and after 8 week training as well.
Participants/Inclusion and exclusion criteria
Pregnant women at age of 20-35 years with no pregnancy complications and no history of programmed exercise participate in this study
Intervention groups
Intervention groups are : aerobic, resistant, combined, and control group .َ All groups primarily do warm up. Then they do special training.At the last stage cool down is done.
The aerobic group do light dance.
The resistant group use theraband .
The combined group do light dance and resistant activities by theraband.
The control group do no programmed exercise.
Main outcome variables
Maternal blood pressure ؛ Maternal and Fetal Heart rate ؛ and Maternal and Fetal Heart rate variability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190227042856N1
Registration date:2019-06-01, 1398/03/11
Registration timing:registered_while_recruiting
Last update:2019-06-01, 1398/03/11
Update count:0
Registration date
2019-06-01, 1398/03/11
Registrant information
Name
khadijeh ahrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2275 4109
Email address
kh.ahrari@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise training mode on maternal blood pressure and maternal and fetal heart rate variability
Public title
The effect of exercise training mode on maternal blood pressure and maternal and fetal heart rate variability
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Women at 20-35 years
Women with no pregnancy complications
women with no history of programmed exercise.
Exclusion criteria:
multiple pregnancy
vaginal bleeding
uterine contractions , history of premature delivery
dyspnea
chest pain
smoking, alcohol consumption , and drug abused
sleep disorder
participation in another programmed exercise
Hypothyroidism and Hyperthyroidism
Diabetes
cervical incompetency
hypertension
History of infertility
BMI more than 25 and less than 18.5
Anemia
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling is used.Randomization is done individually with Random number table.Pregnant women file numbers with inclusion criteria are used. Number of pregnant women is divided on 40 .Considering the obtained number and random number table, subjects are chosen. After that they allocate to control and intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
During the post-intervention measurements, neither the participants nor the assessor was blinded for group assignment. The data analyzer blinded to the participants’ allocation throughout the entire project.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Science and Research Branch
Street address
Islamic Azad University Science and Research Branch Simon Bulivar Blvd, Tehran Post Office Box: 14515/775
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2019-01-22, 1397/11/02
Ethics committee reference number
IR.IAU.SRB.REC.1397.101
Health conditions studied
1
Description of health condition studied
Blood pressure and Heart rate variability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maternal blood pressure that is measured by digital sphygmomanometer device
Timepoint
The 26th and 34th week of pregnancy
Method of measurement
Blood pressure is measured with digital sphygmomanometer made in Switzerland sensitivity 3 mmhg
2
Description
Maternal heart rate variability that is assessed with electrocardiogram machine.
Timepoint
The 26th and 34th week of pregnancy
Method of measurement
Maternal heart rate variability is assessed with electrocardiogram machine Kenzecg 1210 model made in Japan
3
Description
Fetal heart rate variability Is assessed with fetal heart rate monitoring machine .
Timepoint
The 26th and 34th week of pregnancy
Method of measurement
Fetal heart rate variability Is assessed with Bionet fetal heart rate monitoring machine made in south korea FC1900 model with sensitivity of 5% is assessed.
Secondary outcomes
empty
Intervention groups
1
Description
ّThe first Intervention group:This group do aerobic exercise 3 times per week ,each session 50 minutes for 8 weeks.
Category
Lifestyle
2
Description
Second Intervention group: This group do resistance exercise 3 times per week ,each session 50 minutes for 8 weeks.
Category
Lifestyle
3
Description
Third Intervention group:This group do aerobic and resistance exercise 3 times per week ,each session 50 minutes for 8 weeks.
Category
Lifestyle
4
Description
Control group: This group do no special exercise.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar abadi Hospital of Tehran
Full name of responsible person
khadijeh ahrati
Street address
West molavi.,Mohamadieh square., Tehran town
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Web page address
http://crta.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
khadijeh ahrari
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
Post Code: 147789385
Phone
+98 21 4486 5154
Email
kh.ahrari@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
khadijeh ahrari
Position
student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
no 4,saeedi ave.,fereshteh street.,parkway
City
Tehran
Province
Tehran
Postal code
1964944118
Phone
+98 21 2260 5347
Email
kh.ahrari@srbiau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
khadijeh ahrari
Position
student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
no 4,saeedi Ave., Fereshte street.,parkway
City
Tehran
Province
Tehran
Postal code
1964944118
Phone
+98 21 2260 5347
Email
kh.ahrari@srbiau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
khadijeh ahrari
Position
student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
no 4,saeedi Ave.,Fereshteh street.,park way
City
Tehran
Province
Tehran
Postal code
1964944118
Phone
+98 21 2260 5347
Email
kh.ahrari@srbiau.ac.ir
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