Comparison of the effect of eight weeks councarent training on pain intensity and functional disability and quality of life in pregnant women with pregnancy low back pain
Comparison of the effect of 8 weeks of aerobic and resistance exercises on pain intensity, functional disability and quality of life in pregnant women.
Design
The study includes 40 convenient samples who are randomly divided into two experimental and control groups of 20 people.
The experimental group performs exercises for 8 weeks and the control group does not participate in any physical exercises.
Settings and conduct
The samples are randomly selected from among pregnant women with back pain referring to Nikan hospital in Tehran for pregnancy exercise.
Pregnant women with back pain, with the doctor's confirmation that they have the necessary conditions to perform exercises under the supervision of a pregnancy trainer, perform exercises privately and online for a period of 8 weeks and 3 sessions per week. Each exercise session is 45 to 60 minutes long.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Between 16th and 36th weeks of pregnancy.
First and singleton pregnancy& without history of abortion.
with mechanical & non-specific back pain.
Not participating in any specific treatment in last 3 months.
Signing informed consent.
ability to perform practical activities.
Non-entry criteria:
without Doctor's approval to perform pregnancy exercises.
below 20 years & above 35 years.
with any disease related or not related to pregnancy such as diabetes, high blood pressure, etc.
Intervention groups
The experimental group performs 8 weeks of combined exercises under the supervision of a pregnancy trainer.
The control group does not participate in any specific physical exercises or treatment.
Main outcome variables
Back pain during pregnancy, quality of life, disability caused by pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230620058543N1
Registration date:2023-08-09, 1402/05/18
Registration timing:prospective
Last update:2023-08-09, 1402/05/18
Update count:0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
Hengame Rostamy
Name of organization / entity
The Allame Tabatabaee university
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 3929
Email address
hengame.rostami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of eight weeks councarent training on pain intensity and functional disability and quality of life in pregnant women with pregnancy low back pain
Public title
The effect of pregnancy exercises on pain intensity, functional disability and quality of life in pregnancy back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Between 16 and 38 weeks of pregnancy
Doctor approved for pregnancy exercise
Having mechanical and non-specific back pain
Having no history of back pain before pregnancy
It is the person's first pregnancy and no history of abortion
Not participating in any specific treatment for back pain in the last three months
No restrictions in connection with recognition and attention
Sign informed consent to participate in the study
Exclusion criteria:
History of miscarriage and multiple pregnancy
History of having any specific or non-specific treatment for back pain
Lack of doctor's confirmation that you do not have the necessary conditions for pregnancy exercise
Having any disease related or not related to pregnancy such as diabetes, high blood pressure, etc
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of AllameTababaee University
Street address
Quds settlement (West), between South Flamak and Zarafshan, Simai Iran street, Ministry of Health and Medical Education headquarters, block A, 13th floor
City
Tehran
Province
Tehran
Postal code
-814555618
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.ATU.REC.1402.031
Health conditions studied
1
Description of health condition studied
Pragnancy low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Low back pain in pragnancy Quality of life Functional disability
Timepoint
Before doing eight weeks of training and after doing the training protocol
Experimental group (intervention): pregnant women with back pain during pregnancy referring to Nikan Hospital with the doctor's approval do 8 weeks of combined exercises (aerobic and strength) under the supervision of a pregnancy trainer 3 sessions a week and each session lasts 45-60 minutes. And before Performing the protocol and completing the relevant questionnaires after 8 weeks of practice.
Category
Other
2
Description
The control group : pregnant women with back pain who do not participate in any physical exercise.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikan haspital
Full name of responsible person
Laila Panahi
Street address
Plaque 23, corner of Kocheh 20, North Rabzeh St., Zamzam St., Fourth Bridge, Abu Dhar Blvd, pirozi st.
City
Tehran
Province
Tehran
Postal code
1778783115
Phone
+98 21 3316 3939
Email
Hengame.rostami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Allameh Tabatabaei Universityّ
Full name of responsible person
Farideh Babakhani
Street address
Olympic village boulevard, intersection of Shahid Hemet highway, central campus of Allameh Tabatabai University
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
Farideh.Babakhani@atu.ac
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabatabaei Universityّ
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 Allame Tabatabae University
Full name of responsible person
Hengame Rostami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports science
Street address
Plaque 23, corner of Kocheh 20, North Rabzeh St., Zamzam St., Fourth Bridge, Abu Dhar Blvd,Pirozi st.
City
Tehran
Province
Tehran
Postal code
1778783115
Phone
+98 912 419 7618
Email
Hengame.roatami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allameh Tabatabaie University
Full name of responsible person
Hengameh Rostami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport science
Street address
Unit 9, No. 23, No. 23, Corner of Alley 20, North Rabzeh Street, Zamzam Street, Abu Dhar Blvd.
City
Tehran
Province
Tehran
Postal code
1778783115
Phone
+98 912 419 7618
Email
Hengame.rostami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Allame Tabatabae University
Full name of responsible person
Hengame rostami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport sciense
Street address
Plaque 23, corner of Kocheh 20, North Rabzeh St., Zamzam St., Fourth Bridge, Abu Dhar Blvd,Pirozi st.
City
Tehran
Province
Tehran
Postal code
1778783115
Phone
+98 912 419 7618
Email
Hengame.rostami@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