- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712331
Effect of Abdominal Exercises and Russian Stimulation on The Abdominal Muscles Strength After Abdominoplasty
Effect of Preoperative Graduated Abdominal Exercises and Russian Stimulation on The Abdominal Muscles Strength After Abdominoplasty
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Qina, Egypt, 83523
- South Valley University, Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age range between 20-45 years. All patients desire an elective surgical repair.
- All patients were diagnosed with ventral hernia based on surgeon assessment.
- All patients will participate in the study.
- All patients enrolled to the study will have their informed consent.
- All patients are able to act in abdominal training program.
- All patients are able to follow orders during testing and training times.
Exclusion Criteria:
- A strangulated hernia.
- History of surgical interference (abdominal surgery) less than one year.
- Liver cirrhosis with or without ascites.
- Hip or spine deformities or contractures.
- Bowel obstruction, peritonitis, or perforation.
- Local or systemic infection.
- Patient is pregnant or intended to become pregnant during this period.
- Patient has indication for urgent surgery determinate by surgeon.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: The Study group A
they received graduated abdominal strengthening exercises for 30 min., 3 times per week for 6 weeks preoperatively.
|
Graduated abdominal strengthening exercises In this study the following equipments will be used to achieve treatment approaches: Exercise mat and inflatable Swiss ball 55 cm & 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors). |
EXPERIMENTAL: The Study group B
they received Russian stimulation on abdominal muscles for 30 min., 3 times per week for 6 weeks preoperatively.
|
The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.
|
EXPERIMENTAL: The Study group C
they received combination between graduated abdominal strengthening exercises and Russian stimulation on abdominal muscles for 30 min., 3 times per week for 6 weeks preoperatively.
|
Graduated abdominal strengthening exercises and the Russian current stimulation In this study the following equipments will be used to achieve treatment approaches: Exercise mat and inflatable Swiss ball 55 cm & 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors). The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation. |
NO_INTERVENTION: The Control group D
they were instructed to presume in normal activities of daily living preoperatively, without abdominal exercises or Russian stimulation.
|
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: 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: 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.
|
Abdominal muscles peak torque
Time Frame: second or preoperative assessment after 42 days 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 42 days of treatment.
|
Abdominal muscles thickness
Time Frame: second or preoperative assessment after 42 days 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 42 days of treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayman M. Elmakaky, South Valley University
Publications and helpful links
General Publications
- de Vries CEE, Klassen AF, Hoogbergen MM, Alderman AK, Pusic AL. Measuring Outcomes in Cosmetic Abdominoplasty: The BODY-Q. Clin Plast Surg. 2020 Jul;47(3):429-436. doi: 10.1016/j.cps.2020.03.003. Epub 2020 Apr 17.
- Le Roy B, Selvy M, Slim K. The concept of prehabilitation: What the surgeon needs to know? J Visc Surg. 2016 Apr;153(2):109-12. doi: 10.1016/j.jviscsurg.2016.01.001. Epub 2016 Feb 3.
- Knight KA, Moug SJ, West MA. Systematic review: the impact of exercise on mesenteric blood flow and its implication for preoperative rehabilitation. Tech Coloproctol. 2017 Mar;21(3):185-201. doi: 10.1007/s10151-017-1589-9. Epub 2017 Feb 27.
- Valkenet K, van de Port IG, Dronkers JJ, de Vries WR, Lindeman E, Backx FJ. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011 Feb;25(2):99-111. doi: 10.1177/0269215510380830. Epub 2010 Nov 8.
- Park SH, Hwangbo G. Effects of combined application of progressive resistance training and Russian electrical stimulation on quadriceps femoris muscle strength in elderly women with knee osteoarthritis. J Phys Ther Sci. 2015 Mar;27(3):729-31. doi: 10.1589/jpts.27.729. Epub 2015 Mar 31.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/002578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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