1. Home
  2. Approved trials
  3. » فارسی

The Effectiveness of Eight Weeks Suspension Training exercises than Isotonic-Isometric CORE Stabilizer in the Treatment of Diastasis Recti Abdominis in Postpartum Period.

Protocol summary

Study aim
The aim of this clinical trial is to study the effectiveness of Eight Weeks TRX Exercises than Isotonic-Isometric CORE Stabilizer in the Treatment of Diastasis Recti Abdominis in Postpartum Period.
Design
Clinical trials with control group, parallel groups, Double blind Study, randomized
Settings and conduct
Diagnosis of diastasis recti in Fatemieh Hospital and evaluation of study parameters in Sport rehabilitation laboratory of Bu-Ali Sina University in Hamedan, and exercise interventions for 8 weeks (3 sessions in week) will be under the supervision of the researcher. In this study, the evaluators, participants and data analyzers are unaware of the details.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age ranges between 20 and 40 years, The distance between the two rectus abdominal muscles is greater than 2 cm, Above and below the umbilicus and 2.5 cm in the umbilicus area, BMI below 30, WHR Above 0/85, The number of birth above one, Exit criteria: Heart disease, Respiratory Diseases, Postpartum depression,   Abdominal surgery, Anxiety and stress, Gestational Diabetes Mellitus, Smoking, exercises training before and during pregnancy,
Intervention groups
Intervention group: TRX training Intervention group: Isotonic-Isometric CORE Stabilizer training control group: No intervention
Main outcome variables
Linea Alba Width; pain and disability; lumbopelvic proprioception; lumbopelvic control; musculoskeletal disorders of the trunk; balance; pressure distribution

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190219042761N1
Registration date: 2019-07-06, 1398/04/15
Registration timing: retrospective

Last update: 2019-07-06, 1398/04/15
Update count: 0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
Nahid Bigdeli
Name of organization / entity
Bu Ali Sina university
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1423
Email address
n.bigdeli@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-02, 1397/12/11
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Eight Weeks Suspension Training exercises than Isotonic-Isometric CORE Stabilizer in the Treatment of Diastasis Recti Abdominis in Postpartum Period.
Public title
The effect of training interventions in the treatment of diastasis recti.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ranges between 20 and 40 years The distance between the two rectus abdominal muscles is greater than 2 cm above and below the umbilicus and 2.5 cm in the umbilicus area. BMI below 30 WHR Above 0/85 The number of birth above one
Exclusion criteria:
Heart disease Respiratory Diseases Postpartum depression Abdominal surgery Anxiety and stress Gestational Diabetes Mellitus Smoking exercises training before and during pregnancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the subjects were numbered and then we placed them in the Random Number Generator software and the software completely randomly placed the subjects in one of the TRX exercises, isometric-isotonic exercises of the core muscle and the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, assessors of the parameters in the study and data analyzers
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid fahmideh st, Pajuhesh sq, Hamrdan, Iran
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.UMSHA.REC.1397.825

Health conditions studied

1

Description of health condition studied
Diastasis Recti Abdominis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Diastasis Recti Width
Timepoint
30 to 60 days after postpartum
Method of measurement
Digital Caliper

Secondary outcomes

1

Description
pain and disability; lumbopelvic proprioception; lumbopelvic control; musculoskeletal disorders of the trunk; balance; pressure distribution
Timepoint
30 to 60 Days after postpartum
Method of measurement
Visual Analogue Scale, Oswestry Disability Questionnaire, Goniometer, lateral step down test, Flexible ruler, Biodex balance System, Foot pressure measurement system

Intervention groups

1

Description
Intervention group: TRX Training, 24 session and each session is 1 hour, 3 day a week
Category
Rehabilitation

2

Description
Intervention group: than Isotonic-Isometric CORE Stabilizer, 24 session and each session is 1 hour, 3 day a week
Category
Rehabilitation

3

Description
Control group: No Intervention
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital of Hamedan
Full name of responsible person
Roghayeh Anvari Ali Abad
Street address
Fatemieh Hospital, Pasdaran St, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
vc_research@umsha.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Ali Yalfani
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 81 3838 1423
Email
Ali.yalfani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali Sina University
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
Bu Ali Sina University
Full name of responsible person
Ali Yalfani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 81 3838 1423
Email
Ali.yalfani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Ali Yalfani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 81 3838 1423
Email
Ali.yalfani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Nahid Bigdeli
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Phone
+98 81 3838 1423
Email
n.bigdeli@phe.basu.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
Loading...