Effect of Abdominal Exercises and Russian Stimulation on The Abdominal Muscles Strength After Abdominoplasty

NCT04712331 | Unknown

• 1 other identifier: P.T.REC/012/002578
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominoplasty

Keywords

abdominoplasty; Abdominal Exercises; Ultrasonography; Muscle Strength; Russian stimulation

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 42 days 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 42 days 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

they received graduated abdominal strengthening exercises for 30 min., 3 times per week for 6 weeks preoperatively.

Other: Graduated abdominal strengthening exercises

The Study group B

EXPERIMENTAL

they received Russian stimulation on abdominal muscles for 30 min., 3 times per week for 6 weeks preoperatively.

Device: The Russian current stimulation

The Study group C

EXPERIMENTAL

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.

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

The Control group D

NO INTERVENTION

they were instructed to presume in normal activities of daily living preoperatively, without abdominal exercises or Russian stimulation.

Interventions

Graduated abdominal strengthening exercises OTHER

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).

The Study group A

The Russian current stimulation DEVICE

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

The Study group B

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

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.

The Study group C

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University, Faculty of Physical Therapy

Qina, 83523, Egypt

Location

Related 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.

  PMID: 32448479 RESULT

• 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.

  PMID: 26851994 RESULT

• 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.

  PMID: 28243813 RESULT

• 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.

  PMID: 21059667 RESULT

• 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.

  PMID: 25931718 RESULT

Study Officials

• Mohammed E. Ali, Ph.D student

  South Valley University

  PRINCIPAL INVESTIGATOR

• Ayman M. Elmakaky

  South Valley University

  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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: 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

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: October 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)