Muscle StrengthNCT04239417

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

A study testing Graduated abdominal strengthening exercises, The Russian current stimulation and Graduated abdominal strengthening exercises and the Russian current stimulation in people with Muscle Strength, run by South Valley University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 45 years
Conditions the study is for: Muscle Strength
What is being tested?: Graduated abdominal strengthening exercises, The Russian current stimulation and Graduated abdominal strengthening exercises and the Russian current stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 1 Oct 2019to 1 Apr 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
All sexes
No healthy volunteers
Adult

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

South Valley University, Faculty of Physical Therapy
Qina, 83523

Other trials in Egypt

About this study

Official title: Effect of Preoperative Graduated Abdominal Exercises and Russian Current Stimulation on Muscle Strength Post Ventral Hernioplasty

Read the detailed description

Conditions: Muscle Strength
Being tested: Graduated abdominal strengthening exercises, The Russian current stimulation, Graduated abdominal strengthening exercises and the Russian current stimulation
Keywords: ventral hernia, graduated abdominal exercises, isokinetic dynamometer.
Medical subject headings: Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Graduated abdominal strengthening exercisesOther
1. Exercise mat and inflatable Swiss ball
2. Wall bar, wedges, elastic tubing
The Russian current stimulationDevice
The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.
Graduated abdominal strengthening exercises and the Russian current stimulationCombination product
Combination between The Russian current and abdominal exercises

Study groups in NCT04239417
Study group	Role	What they receive
The Study group A	Experimental	graduated abdominal strengthening exercises group Receives: Other: Graduated abdominal strengthening exercises
The Study group B	Experimental	Russian stimulation group Receives: Device: The Russian current stimulation
The Study group C	Experimental	combination group Receives: Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulation
The Control group D	No intervention	presume in normal activities of daily living.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: fourth assessment at 4 months post-operative.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20191 Apr 2020

First posted27 Jan 2020
Study start1 Oct 2019
Primary completion1 Apr 2020
Study completion1 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Muscle StrengthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
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 ).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04239417
Sponsor's protocol ID: P.T.REC/012/002036
Status last verified: Mar 2021
First submitted: 20 Jan 2020
Last updated: 29 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ward AR, Shkuratova N. Russian electrical stimulation: the early experiments. Phys Ther. 2002 Oct;82(10):1019-30.
PubMed 12350217
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.
PubMed 16284131
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.
PubMed 25198958
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.
PubMed 24146704
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.
PubMed 28692907
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.
PubMed 22312327
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.
PubMed 26348707
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.
PubMed 19698092
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.
PubMed 26557405
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.
PubMed 20437188
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.
PubMed 27681867
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.
PubMed 24478827
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.
PubMed 20840351
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.
PubMed 21187986
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.
PubMed 19296196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Muscle Strength trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Preoperative Graduated Abdominal Exercises and Russian Current Stimulation on Muscle Strength Post Ventral Hernioplasty
ClinicalTrials.gov ID: NCT04239417
Acronym / sponsor ID: P.T.REC/012/002036
Conditions: Muscle Strength
Keywords: ventral hernia, graduated abdominal exercises, isokinetic dynamometer.
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: South Valley UniversityUniversity, hospital or other
Study start: 1 Oct 2019 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 Apr 2020 (actual)
First posted: 27 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4
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 ).

Arm	Type	Receives
The Study group A	Experimental	Other: Graduated abdominal strengthening exercisesgraduated abdominal strengthening exercises group
The Study group B	Experimental	Device: The Russian current stimulationRussian stimulation group
The Study group C	Experimental	Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulationcombination group
The Control group D	No intervention	–presume in normal activities of daily living.

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Graduated abdominal strengthening exercises1. Exercise mat and inflatable Swiss ball 2. Wall bar, wedges, elastic tubing	Other	The Study group A
The Russian current stimulationThe Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.	Device	The Study group B
Graduated abdominal strengthening exercises and the Russian current stimulationCombination between The Russian current and abdominal exercises	Combination product	The Study group C

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
Background: PubMed 12350217Ward AR, Shkuratova N. Russian electrical stimulation: the early experiments. Phys Ther. 2002 Oct;82(10):1019-30.
Background: PubMed 16284131Aguirre 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.
Background: PubMed 25198958Ahmed 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.
Background: PubMed 24146704de 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.
Background: PubMed 28692907Deeken 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.
Results publication: PubMed 22312327Young 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.
Results publication: PubMed 26348707Howell 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.
Results publication: PubMed 19698092Wang 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.
Results publication: PubMed 26557405Vinstrup 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.
Results publication: PubMed 20437188van 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.
Results publication: PubMed 27681867Aboodarda 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.
Results publication: PubMed 24478827Allen 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohammed E. Ali, PhD student principal investigator

South Valley University, Faculty of Physical Therapy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal muscles peak torque (time frame: first or initial assessment at day 0.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04239417, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.