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Clinical Trials/NCT04712331
NCT04712331UnknownNot Applicable

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

South Valley University1 site in 1 country60 target enrollmentStarted: October 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Abdominal muscles peak torque

Study Overview

Brief Summary

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

Detailed 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

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 )

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

The Study group A

Experimental

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

Intervention: Graduated abdominal strengthening exercises (Other)

The Study group B

Experimental

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

Intervention: The Russian current stimulation (Device)

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.

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

The Control group D

No Intervention

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

Outcomes

Primary Outcomes

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: 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.

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 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.

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 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 42 days 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed E. Ali, Ph. D Candidate.

Assistant Lecturer

South Valley University

Study Sites (1)

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