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临床试验/NCT04712331
NCT04712331Unknown不适用

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

South Valley University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Abdominal muscles peak torque

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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 )

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

The Study group A

Experimental

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

干预措施: 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.

干预措施: 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.

干预措施: 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.

结局指标

主要结局

Abdominal muscles peak torque

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed E. Ali, Ph. D Candidate.

Assistant Lecturer

South Valley University

研究点 (1)

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