- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239417
Effect of Preoperative Abdominal Exercises and Russian Current on Muscle Strength Post Ventral Hernioplasty
March 24, 2021 updated by: Mohammed E. Ali, Ph. D Candidate., South Valley University
Effect of Preoperative Graduated Abdominal Exercises and Russian Current Stimulation on Muscle Strength Post Ventral Hernioplasty
The study was conducted to investigate the effect of preoperative graduated abdominal strengthening exercises and Russian stimulation on the abdominal muscles strength after ventral hernioplasty by using isokinetic dynamometer and Ultrasonography as methods of measurement.
Study Overview
Status
Completed
Conditions
Detailed Description
The study was conducted to investigate the effect of preoperative graduated abdominal strengthening exercises and Russian stimulation on the abdominal muscles strength after ventral hernioplasty by using isokinetic dynamometer and Ultrasonography as methods of measurement.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Qina, Egypt, 83523
- South Valley University, Faculty of Physical Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Criteria of inclusion:
- The age is from 20 to 45 years.
- All patients want to optionally repair surgery.
- Ventral hernia is diagnosed on the basis of a surgeon evaluation.
- The study will include all patients.
- The informed consent of all the patients enrolled.
Criteria for exclusion:
- history of surgical interference for less than one year (abdominal surgery).
- Cirrhosis of the liver with ascites or without them.
- Deformity or contracture of the hip or spine.
- Obstruction of bowel, peritonitis or drilling.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The Study group A
graduated abdominal strengthening exercises group
|
|
Experimental: The Study group B
Russian stimulation group
|
The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.
|
Experimental: The Study group C
combination group
|
Combination product: Graduated abdominal strengthening exercises and the Russian current stimulation
Combination between The Russian current and abdominal exercises
|
No Intervention: The Control group D
presume in normal activities of daily living.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal muscles peak torque
Time Frame: first or initial assessment at day 0.
|
Peak torque is the single highest torque output of the joint produced by muscular contraction as the limb moves through the range of motion.
|
first or initial assessment at day 0.
|
Abdominal muscles peak torque
Time Frame: second or preoperative assessment after 6 weeks of treatment.
|
Peak torque is the single highest torque output of the joint produced by muscular contraction as the limb moves through the range of motion.
|
second or preoperative assessment after 6 weeks of treatment.
|
Abdominal muscles peak torque
Time Frame: third assessment at 2 months post-operative.
|
Peak torque is the single highest torque output of the joint produced by muscular contraction as the limb moves through the range of motion.
|
third assessment at 2 months post-operative.
|
Abdominal muscles peak torque
Time Frame: fourth assessment at 4 months post-operative.
|
Peak torque is the single highest torque output of the joint produced by muscular contraction as the limb moves through the range of motion.
|
fourth assessment at 4 months post-operative.
|
Abdominal muscles thickness
Time Frame: first or initial assessment at day 0.
|
it is a method for muscle strength measurement as muscle strength is correlated to its cross section or diameter.
|
first or initial assessment at day 0.
|
Abdominal muscles thickness
Time Frame: second or preoperative assessment after 6 weeks of treatment.
|
it is a method for muscle strength measurement as muscle strength is correlated to its cross section or diameter.
|
second or preoperative assessment after 6 weeks of treatment.
|
Abdominal muscles thickness
Time Frame: third assessment at 2 months post-operative.
|
it is a method for muscle strength measurement as muscle strength is correlated to its cross section or diameter.
|
third assessment at 2 months post-operative.
|
Abdominal muscles thickness
Time Frame: fourth assessment at 4 months post-operative.
|
it is a method for muscle strength measurement as muscle strength is correlated to its cross section or diameter.
|
fourth assessment at 4 months post-operative.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammed E. Ali, PhD student, South Valley University, Faculty of Physical Therapy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ward AR, Shkuratova N. Russian electrical stimulation: the early experiments. Phys Ther. 2002 Oct;82(10):1019-30.
- Aguirre DA, Santosa AC, Casola G, Sirlin CB. Abdominal wall hernias: imaging features, complications, and diagnostic pitfalls at multi-detector row CT. Radiographics. 2005 Nov-Dec;25(6):1501-20. doi: 10.1148/rg.256055018.
- Ahmed U, Ahmed R, Kamat S, Elkholy K. An ovary as unusual contents of an incarcerated umbilical hernia. Ann R Coll Surg Engl. 2014 Sep;96(6):e4-5. doi: 10.1308/003588414X13946184901443.
- de Carvalho Froufe Andrade AC, Caserotti P, de Carvalho CM, de Azevedo Abade EA, da Eira Sampaio AJ. Reliability of Concentric, Eccentric and Isometric Knee Extension and Flexion when using the REV9000 Isokinetic Dynamometer. J Hum Kinet. 2013 Jul 5;37:47-53. doi: 10.2478/hukin-2013-0024. eCollection 2013.
- Deeken CR, Lake SP. Mechanical properties of the abdominal wall and biomaterials utilized for hernia repair. J Mech Behav Biomed Mater. 2017 Oct;74:411-427. doi: 10.1016/j.jmbbm.2017.05.008. Epub 2017 May 6.
- Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.
- Howell B, Medina LE, Grill WM. Effects of frequency-dependent membrane capacitance on neural excitability. J Neural Eng. 2015 Oct;12(5):056015-56015. doi: 10.1088/1741-2560/12/5/056015. Epub 2015 Sep 8.
- Wang HQ, Wei YY, Wu ZX, Luo ZJ. Impact of leg lengthening on viscoelastic properties of the deep fascia. BMC Musculoskelet Disord. 2009 Aug 21;10:105. doi: 10.1186/1471-2474-10-105.
- Vinstrup J, Sundstrup E, Brandt M, Jakobsen MD, Calatayud J, Andersen LL. Core Muscle Activity, Exercise Preference, and Perceived Exertion during Core Exercise with Elastic Resistance versus Machine. Scientifica (Cairo). 2015;2015:403068. doi: 10.1155/2015/403068. Epub 2015 Oct 18.
- van Bemmel AJ, van Marle AG, Schlejen PM, Schmitz RF. Handlebar hernia: a case report and literature review on traumatic abdominal wall hernia in children. Hernia. 2011 Aug;15(4):439-42. doi: 10.1007/s10029-010-0665-0. Epub 2010 May 1.
- Aboodarda SJ, Page PA, Behm DG. Muscle activation comparisons between elastic and isoinertial resistance: A meta-analysis. Clin Biomech (Bristol, Avon). 2016 Nov;39:52-61. doi: 10.1016/j.clinbiomech.2016.09.008. Epub 2016 Sep 20.
- Allen WM, Xu Z, Asman AJ, Poulose BK, Landman BA. Quantitative Anatomical Labeling of the Anterior Abdominal Wall. Proc SPIE Int Soc Opt Eng. 2013 Mar 28;8673:867312. doi: 10.1117/12.2007071.
- Becker I, Woodley SJ, Stringer MD. The adult human pubic symphysis: a systematic review. J Anat. 2010 Nov;217(5):475-87. doi: 10.1111/j.1469-7580.2010.01300.x. Epub 2010 Sep 14.
- Campanelli G, Pettinari D, Cavalli M, Avesani EC. Inguinal hernia recurrence: Classification and approach. J Minim Access Surg. 2006 Sep;2(3):147-50. doi: 10.4103/0972-9941.27728.
- Dur AH, den Hartog D, Tuinebreijer WE, Kreis RW, Lange JF. Low recurrence rate of a two-layered closure repair for primary and recurrent midline incisional hernia without mesh. Hernia. 2009 Aug;13(4):421-6. doi: 10.1007/s10029-009-0487-0. Epub 2009 Mar 19.
- Ellenbecker TS, Davies GJ. The application of isokinetics in testing and rehabilitation of the shoulder complex. J Athl Train. 2000 Jul;35(3):338-50.
- Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
January 20, 2020
First Submitted That Met QC Criteria
January 20, 2020
First Posted (Actual)
January 27, 2020
Study Record Updates
Last Update Posted (Actual)
March 29, 2021
Last Update Submitted That Met QC Criteria
March 24, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/002036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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