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临床试验/NCT06301126
NCT06301126进行中(未招募)不适用

Effect of Virtual Reality on Pulmonary Function, Respiratory Muscle Strength and Functional Capacity After Upper Abdominal Surgeries

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Forced vital capacity (FVC)

研究概览

简要总结

After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain.

详细描述

Virtual reality (VR) encourages an environment that attempts to create a moment of entertainment, motivation, and enjoyment with a variety of stimuli, with movements that stimulate physical and cognitive development, as well as the patient's active participation in the rehabilitation process. It is possible to assist in the alleviation of pain using the platform, at a low cost, through the playfulness given during rehabilitation, with an effective consumption of oxygen, range of motion, and use of the respiratory muscles more efficiently.

Participants with upper abdominal surgery will be randomly distributed into Group A (VR Group) which will receive VR for plus conventional physical therapy program and Group B (Control Group) which will receive conventional physical therapy program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergone open upper abdominal surgery (hernia repair, cholecystectomy, large bowel removal, conventional laparotomy)
  • •no prior surgical intervention for esophageal, gastric, or biliary tract resection
  • •age 18-60 years
  • •acceptable physical condition (permitting pulmonary function and functional capacity test).

排除标准

  • •Cerebrovascular disease
  • •use of immunosuppressants within 30 days of surgery
  • •cardiovascular instability
  • •chest physical therapy within the 8 weeks preceding study enrollment
  • •visual impairment or hearing impairment;
  • •bed-ridden patients;
  • •any lung disorders
  • •insulin-dependent diabetes mellitus
  • •less than 6-months post thoracic or cardiac surgery
  • •musculoskeletal impairment
  • •cognitive disorders
  • •Patients undergoing laparoscopic surgery as this induces smaller changes in the postoperative breathing mechanics than laparotomy does
  • •heavy smokers or alcoholism

研究组 & 干预措施

Virtual reality

Experimental

Participants will receive VR for 20 minutes followed by conventional physical therapy program for 45 minutes, 5 days/ week for 8 weeks.

干预措施: Virtual reality (Other)

Virtual reality

Experimental

Participants will receive VR for 20 minutes followed by conventional physical therapy program for 45 minutes, 5 days/ week for 8 weeks.

干预措施: conventional physical therapy exercise program (Other)

Control

Active Comparator

Participants will receive conventional physical therapy program (Deep diaphragmatic, costal breathing exercises, bronchial hygiene techniques and assisted cough) for 45 minutes, 5 days/ week for 8 weeks.

干预措施: conventional physical therapy exercise program (Other)

结局指标

主要结局

Forced vital capacity (FVC)

时间窗: 8 weeks

FVC will be measured by using spirometer.

次要结局

  • Respiratory muscle strength(8 weeks)
  • diaphragmatic mobility(8 weeks)
  • Functional capacity(8 weeks)
  • Peak expiratory flow (PEF)(8 weeks)
  • Forced expiratory volume in 1 second (FEV1)(8 weeks)

研究者

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

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Cairo University

研究点 (1)

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