Effect of Preoperative Abdominal Exercises and Russian Current on Muscle Strength Post Ventral Hernioplasty

• Sponsor: South Valley University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04239417
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 4
• Actual Duration (Months): 6
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Strength	Other: Graduated abdominal strengthening exercises; Device: The Russian current stimulation; Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: Sixty patients with ventral hernia, preoperatively, were randomly distributed into four equal groups: groups (A) & (B) & (C) ( three study groups ) and group (D) ( control group ).Sixty patients with ventral hernia, preoperatively, were randomly distributed into four equal groups: groups (A) & (B) & (C) ( three study groups ) and group (D) ( control group ).
• Masking: Single (Outcomes Assessor)
• Masking Description: Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: groups (A) & (B) & (C) ( three study groups ) and group (D) ( control group )
• Primary Purpose: Treatment
• Official Title: Effect of Preoperative Graduated Abdominal Exercises and Russian Current Stimulation on Muscle Strength Post Ventral Hernioplasty
• Actual Study Start Date: Oct 1, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The Study group A graduated abdominal strengthening exercises group	Other: Graduated abdominal strengthening exercises; Exercise mat and inflatable Swiss ball Wall bar, wedges, elastic tubing
Experimental: The Study group B Russian stimulation group	Device: The Russian current stimulation; 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.

Outcome Measures

Primary Outcome Measures

1. Abdominal muscles peak torque [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.

2. Abdominal muscles peak torque [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.

3. Abdominal muscles peak torque [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.

4. Abdominal muscles peak torque [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.

5. Abdominal muscles thickness [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.

6. Abdominal muscles thickness [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.

7. Abdominal muscles thickness [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.

8. Abdominal muscles thickness [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Valley University, Faculty of Physical Therapy	Qina		Egypt	83523

Sponsors and Collaborators

• South Valley University

Investigators

• Principal Investigator: Mohammed E. Ali, PhD student, South Valley University, Faculty of Physical Therapy

Study Documents (Full-Text)

• Study Protocol - Mar 22, 2021

More Information

Publications

• 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. Review.
• 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. Review.
• Ward AR, Shkuratova N. Russian electrical stimulation: the early experiments. Phys Ther. 2002 Oct;82(10):1019-30.

• Responsible Party: Mohammed E. Ali, Ph. D Candidate., Assistant Lecturer, South Valley University
• ClinicalTrials.gov Identifier: NCT04239417
• Other Study ID Numbers: P.T.REC/012/002036
• First Posted: Jan 27, 2020
• Last Update Posted: Mar 29, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohammed E. Ali, Ph. D Candidate., Assistant Lecturer, South Valley University: ventral hernia; graduated abdominal exercises; isokinetic dynamometer.

Study Results

No Results Posted as of Mar 29, 2021