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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04712331
Other study ID # P.T.REC/012/002578
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date February 1, 2021

Study information

Verified date January 2021
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the effect of preoperative graduated abdominal exercises and Russian stimulation on the abdominal muscles' strength after abdominoplasty


Description:

To investigate the effect of preoperative graduated abdominal exercises and Russian stimulation on the abdominal muscles' strength after abdominoplasty. Sixty patients will undergo abdominoplasty, their age ranged from 20 to 45 years, they were randomly distributed into four equal groups. The ultrasonography was used to evaluate abdominal muscle thickness as indicator for muscle strength at 4 occasions, initial assessment, pre-operative assessment, 2 months post-operative assessment, and finally 4 months post-operative assessment). For study group (A); received graduated abdominal exercises, group (B); received Russian stimulation on abdominal muscles, group (c); received combination between graduated abdominal exercises and Russian stimulation on abdominal muscles, the study groups received the treatment protocol for 30 min., 3 times per week for 6 weeks preoperatively for control group (D); were instructed to presume in normal activities of daily living preoperatively


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date February 1, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Graduated abdominal strengthening exercises
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).
Device:
The Russian current stimulation
The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.
Other:
Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulation
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.

Locations

Country Name City State
Egypt South Valley University, Faculty of Physical Therapy Qina

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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 — View Citation

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. Re — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 42 days of treatment.
Primary 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.
Primary 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.
Primary 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.
Primary 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 42 days of treatment.
Primary 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.
Primary 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.
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