NCT04239417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

January 20, 2020

Last Update Submit

March 24, 2021

Conditions

Keywords

ventral herniagraduated abdominal exercisesisokinetic dynamometer.

Outcome Measures

Primary Outcomes (8)

  • Abdominal muscles peak torque

    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

    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

    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

    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

    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

    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

    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

    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.

Study Arms (4)

The Study group A

EXPERIMENTAL

graduated abdominal strengthening exercises group

Other: Graduated abdominal strengthening exercises

The Study group B

EXPERIMENTAL

Russian stimulation group

Device: The Russian current stimulation

The Study group C

EXPERIMENTAL

combination group

Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulation

The Control group D

NO INTERVENTION

presume in normal activities of daily living.

Interventions

1. Exercise mat and inflatable Swiss ball 2. Wall bar, wedges, elastic tubing

The Study group A

The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.

The Study group B

Combination between The Russian current and abdominal exercises

The Study group C

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

Location

Related Publications (17)

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

    PMID: 12350217BACKGROUND
  • 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.

    PMID: 16284131BACKGROUND
  • 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.

    PMID: 25198958BACKGROUND
  • 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.

    PMID: 24146704BACKGROUND
  • 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.

    PMID: 28692907BACKGROUND
  • 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). 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.

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammed E. Ali, PhD student

    South Valley University, Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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 )
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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 ).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 27, 2020

Study Start

October 1, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

March 29, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations