The effect of core stabilization exercises focusing on pelvic floor and deep abdominal muscles on pain, functional disability and quality of life in pregnant women with lumbopelvic pain
An appropriate guide to relieving lumbopelvic pain in pregnant women in a specific, targeted and conservative manner.
Design
Clinical trial with community-based and pragmatic control group, with parallel, double-blind, randomized groups
Settings and conduct
This study is done for 10 weeks and 3 sessions a week in the training group. Each group therapy session lasted 60 minutes, including 10 minutes of general warm-up, 40 minutes of stability exercises, focusing on the deep abdominal and pelvic floor muscles, and 10 minutes of cooling exercises.
Participants/Inclusion and exclusion criteria
Entry Requirements:
18 years and older
First pregnancy
Week 14-18 of pregnancy
Lumbopelvic pain for more than one week
Exit Requirements:
Abortion history
High-risk pregnancy
Medicinal Therapies during pregnancy
Lumbopelvic pain history before pregnancy
Contra indication of exercise during pregnancy to diagnose of doctor
Intervention groups
In the training group, stability exercises on deep abdominal muscles and pelvic floor muscles in 3 stages is done by isometric contraction, isolation contraction and co-contraction, then loading low load into them and eventually combining with functional postures.The control group only received usual care and education from a doctor or midwife, but they are not prohibited from exercising themselves.
Main outcome variables
Intensity of pain, functional ability, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181007041265N1
Registration date:2018-10-24, 1397/08/02
Registration timing:registered_while_recruiting
Last update:2018-10-24, 1397/08/02
Update count:0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Hosein Negahban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 7029
Email address
negahbanh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of core stabilization exercises focusing on pelvic floor and deep abdominal muscles on pain, functional disability and quality of life in pregnant women with lumbopelvic pain
Public title
Stabilization exercises in improvement of lumbopelvic pain in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years and older
First pregnancy
Week 14-18 of pregnancy
Lumbopelvic pain more than 1 week
Exclusion criteria:
Abortion history
High-risk pregnancy
Medicinal Therapies during pregnancy
Lumbopelvic pain history before pregnancy
Contra indication of exercise during pregnancy to diagnose of doctor
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be unaware of the existence of the two groups and which group they are in.
An individual has the responsibility to evaluate patients in three stages as well as which group of patients will be unaware of.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakilabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185763788
Approval date
2018-10-07, 1397/07/15
Ethics committee reference number
IR.MUMS.REC.1397.163
Health conditions studied
1
Description of health condition studied
Lumbopelvic pains
ICD-10 code
026
ICD-10 code description
Maternal care for other conditions predominantly related to pregnancy
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before the start of the treatment, immediately after the completion of the program, the last week of pregnancy and 6 weeks after delivery
Method of measurement
Visual Analogue Scale
2
Description
Functional disability
Timepoint
Before the start of the treatment, immediately after the completion of the program, the last week of pregnancy and 6 weeks after delivery
Method of measurement
Oswestry disability index questionnaire
3
Description
Quality of Life
Timepoint
Before the start of the treatment, immediately after the completion of the program, the last week of pregnancy and 6 weeks after delivery
Method of measurement
The World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study was conducted for 10 weeks and 3 sessions per week in the training group, one session grouped under the supervision of a physiotherapist. Since it's difficult to attend training sessions at all sessions, doing 2 sessions of weekly exercises is done by giving a visual instruction to a person at home. Each group therapy session lasted for 60 minutes, including 10 minutes of general warm-up (walking), 40 minutes of stability training, focusing on abdominal muscles and pelvic floor, and 10 minutes of cooling training (including breathing and relaxation exercises).The exercises at home are similar to the same group exercises and are performed at least twice a week for 30 minutes. In the training group, the exercise is performed in three stages, such that the first phase consists of four sessions, which in 2 sessions First, on the isometric contraction and the isolation of the abdominal muscles and pelvic floor muscles in various positions, such as four hands and feet, supine, sitting and standing, and in the next 2 sessions, exercises were made by concurrent abdominal muscles and pelvic floor muscles in the position The above mentioned is done. The second stage, if properly performed, will begin muscle contraction, so that 3 sessions, while maintaining abdominal contraction and pelvic floor, will be loaded quantitatively by the controlled movements of the limbs in different positions. In the third phase, during 3 sessions, this is also a contraction of the muscles, with functional postures and activities that have already exacerbated the symptoms of the patient. At this stage, the patient is encouraged to activate these muscles regularly during daily activities. It should be noted that during each treatment session, each of the exercises will be performed in 10set 10 second
Category
Treatment - Other
2
Description
Control group: The control group received only the usual care and education from the doctor or midwife, but they are not prohibited from exercising themselves.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mobini hospital
Full name of responsible person
Samira Farazmehr
Street address
Mobini hospital, Kashefi Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613984191
Phone
+98 51 4423 8100
Email
mobini.h@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakilabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185763788
Phone
+98 51 3882 7029
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hosein Negahban
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Vakilabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185763788
Phone
+98 51 3882 7029
Email
negahbanh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hosein Negahban
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Vakilabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185763788
Phone
+98 51 3882 7029
Email
negahbanh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hosein Negahban
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Vakilabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185763788
Phone
+98 51 3882 7029
Email
negahbanh@mums.ac.ir
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