Protocol summary

Study aim
Comparison of effect of isometric exercisees and pelvic tilt on the lumbar and pelvic pain in secondary trimester of pregnancy
Design
Clinical trial with a control group, with parallel, randomized groups with a sample size of 120 people
Settings and conduct
The researcher started to sample qualified people by referring to clinics in Bushehr during the study period. Then Each of the two test groups receive basic training individually in theory and practice by the trained individual. In the control group, only routine pregnancy cares is done. At the beginning of the study, Week 4 and Eighth Week, extent and severity of back and hip pain are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primary gravida women, Age 18-35, 16-28 weeks of pregnancy, Visual Analog Scale(VAS) score of 20mm-70mm, Normal Body Mass Index(BMI), Not having a history of back pain before pregnancy, Not having a practice ban during pregnancy, Having reading and writing skills
Intervention groups
Intervention group 1: Isometric exercises are performed in the supine position. Over the course of eight weeks, it is done five times per week and it involves the isometric contraction of the abdominal transverse muscles, the gluteal and the bottom of the pelvic, that each contraction is kept 5 seconds and 5 seconds rest with iteration 10 times. Intervention group 2: The tilt exercise is performed in the supine position.While the legs extend outwards and stomach muscles and lower pelvis and buttock are contract, they lift the joint from the ground. they hold the position for five seconds and then released.The exercises are performed twice a day and 5 days a week for eight weeks.Control group: In the control group, only routine pregnancy cares is done.
Main outcome variables
The severity of back pain; The severity of pelvic pain; Duration of back pain; Duration of pelvic pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190410043227N1
Registration date: 2019-08-24, 1398/06/02
Registration timing: registered_while_recruiting

Last update: 2019-08-24, 1398/06/02
Update count: 0
Registration date
2019-08-24, 1398/06/02
Registrant information
Name
Sara Jomhouri angali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3367 2979
Email address
s.jomhouri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-09, 1398/05/18
Expected recruitment end date
2019-10-11, 1398/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of isometric exercises and pelvic tilt on the lumbar and pelvic pain in secondary trimester in primary gravida women
Public title
Comparison of effect of isometric exercises and pelvic tilt on the lumbar and pelvic pain in primary gravida women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary gravida women Age 18-35 16-28 weeks of pregnancy Visual Analog Scale(VAS) score of 20mm-70mm Normal Body Mass Index(BMI) Not having a history of back pain before pregnancy Not having a practice ban during pregnancy Having reading and writing skills Satisfaction and willingness to participate in the study
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization with a block size of 3 is used. Different permutations with the following sequence assigned to 1-6 include A=STUDY1, B=STUDY2, C=CONTROL, 1.ABC, 2.ACB, 3.BAC, 4.BCA, 5.CAB and 6.CBA. The numbers are now extracted from a table of random numbers in a way that 55 blocks of size 3 are selected one at a time and depending on the corresponding randomly-selected number between 1 and 6. Zero, seven, eight and nine are ignored if selected, and the procedure continues until the list is completed for the whole sample.
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand Ave.,
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.SUMS.REC.1398.208

Health conditions studied

1

Description of health condition studied
Back pain
ICD-10 code
M54.5
ICD-10 code description
low back pain

2

Description of health condition studied
Pelvic pain
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen

Primary outcomes

1

Description
Visual Analogue Scale score of back pain
Timepoint
Before intervention, 4 & 8 weeks later
Method of measurement
Visual Analogue Scale questionnaire

2

Description
Pelvic pain severity
Timepoint
Before intervention, 4 & 8 weeks later
Method of measurement
Active Straight Leg Raise(ASLR) test

Secondary outcomes

empty

Intervention groups

1

Description
In the first group, isometric exercises are performed in the supine position. Over the course of eight weeks, is done five times a week. It is done five times per week and it involves the isometric contraction of the abdominal transverse muscles, the gluteal and the bottom of the pelvis, that each contraction is kept 5 seconds and 5 seconds rest with iteration 10 times.
Category
Treatment - Other

2

Description
In the second group, the tilt exercise is performed in the supine position with the bent over of the knees and hip on the ground. While the legs extend outwards and stomach muscles and lower pelvis and buttock are contract, they lift the joint from the ground. With a deep breath, they hold the position for five seconds and then released. Then they place their buttock on the ground and relax their musceles for 5 seconds. The exercises are performed within five days of the week for eight weeks with a repeat of 2 times a day.
Category
Treatment - Other

3

Description
In the control group, only routine pregnancy cares is done and Do not see any training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of Bushehr city
Full name of responsible person
Hasan Fakhraei
Street address
Health center of Bushehr city, Dashtestan Alley, Daneshamooz Ave
City
Bushehr
Province
Boushehr
Postal code
7516965593
Phone
+98 77 3335 0038
Fax
Email
bu_hc_2008@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yuones Ghasemi
Street address
Central building of Shiraz University of Medical Sciences, Opposite the street of Palestine, Zand Ave.,
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶۷۱۳۴۸
Phone
+98 71 3212 2430
Email
vrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Jomhouri Angali
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of nursing and midwifery, Namazi Square, Zand Ave.,
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
s.jomhouri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Jomhouri Angali
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of nursing and midwifery, Namazi Square, Zand Ave.,
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
s.jomhouri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Jomhouri Angali
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of nursing and midwifery, Namazi Square, Zand Ave.,
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
s.jomhouri@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
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