跳至主要内容
临床试验/NCT04297306
NCT04297306Unknown不适用

The Use of Virtual Reality Exercise Games to Improve Prehabilitation Exercise Compliance in Patients Awaiting Bariatric Surgery

Royal Cornwall Hospitals Trust2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Heart rate and Heart rate variability using Activity Tracker

研究概览

简要总结

Exercise is a vital part of cardiopulmonary conditioning, this means improving general fitness. Undertaking surgery has been likened, physiologically, to running a marathon. It is essential that before any operation the patient undergoing the procedure is as optimised as possible.

Bariatric surgery is no exception. Patients with a high weight often have other conditions most commonly related to the heart and lungs through the excess visceral fat content. This places this group of patients at particular risk of potentially, albeit rare, of having a major and possibly catastrophic cardiac event on the operating table during anaesthetic. Pre-operative conditioning is therefore vital in this group of patients who are often young and not other than their weight necessarily unwell. Exercise plays an important role in the run up to surgery however, many pre-operative exercise prescription programs in the past have failed, often related to the lack of compliance. However, this maybe due to the poor body image they have of themselves presenting in public to the gym or swimming pool.

Current Virtual Reality Games propose that, through their use they encourage exercise and increase heart rate. Given the more personalised nature of this form of media over public engagement, this new media may offer an opportunity to explore whether there is any benefit in terms of pre-conditioning this group of patients prior to their surgery. This study aims, in its first instance, to evaluate whether the Virtual Reality promoted exercise games encourage and can sustain increased activity prior to surgery.

详细描述

It is estimated that the annual social care costs of obesity to NHS local authorities is £352 million. Obesity surgery currently offers the only long term cure but it carries substantial risk to a group of patients who are often young with other obesity related health concerns; including of the heart and lungs.

The need to improve the condition of the heart and lungs within this patient group prior to surgery is essential. Activity can improve these organs and promote a much lower risk during surgery, reducing the risk of heart attacks or dangerous abnormal rhythms of the heart from occurring during the procedure.

Although exercise alone cannot support long term weight-loss it is vital to promoting a stronger healthier heart in the short term prior to surgery.

This study aims to explore the use of Virtual Reality Gaming to increase activity within this patient group compared to simply encouraging exercise as is undertaken in standard current practice. The initial consideration is as to whether this new media is capable of increasing activity in this group and hopefully improve their heart and lungs going into surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients referred to the Weight Management and Obesity Surgery Service at the Royal Cornwall Hospital between January 2020 and December 2020 for Primary Bariatric Surgery.
  • Patients aged 18yrs and over.
  • Patient able to consent (with or without interpreter).
  • Patient able to undergo a general anaesthetic (seen by anaesthetist).

排除标准

  • Patients referred for Revisional Bariatric Surgery.
  • Patients unable to use the Virtual Reality Gaming system.
  • Patient unable to consent.
  • Patients without a clear understanding of the English language.

结局指标

主要结局

Heart rate and Heart rate variability using Activity Tracker

时间窗: 6 weeks preoperatively

Measured using Activity tracker

Complications at surgery using Clavien-Dindo Classification

时间窗: 90 days post operatively

Record of 90 day surgical complications

Activity minutes using Activity tracker

时间窗: 6 weeks preoperatively

Measured using Activity tracker

Calories Burnt using Activity Tracker

时间窗: 6 weeks preoperatively

Measured using Activity tracker

次要结局

  • Total excess Weight-loss post surgery (Kg)(18 months)

研究者

发起方
Royal Cornwall Hospitals Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Virtual Reality Exercise Gaming in Patients Awaiting... | 临床试验