Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery

NCT ID: NCT04297306

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bariatric Surgery Prehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Case-controlled trial randomised, prospective trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise prescription

This group will be provided with a prescript exercise program, taken from UK National Guidance.

The advice will be directed to be undertaken for 6 weeks immediately prior to surgery.

Group Type ACTIVE_COMPARATOR

Exercise Prescription

Intervention Type BEHAVIORAL

Standardised Exercise Prescription.

Exercise prescription and Virtual Reality Exercise Gaming

This group will be provided with a prescript exercise program as in Arm 1. However, this group of patients will also be presented with a Virtual Reality Headset, pre-programmed with Exercise promoted games which will be provided to support and encourage their exercise regimen.

Again this advice and support will be directed to be undertaken for 6 weeks immediately prior to surgery.

Group Type EXPERIMENTAL

Exercise Prescription and Virtual Reality Exercise Gaming support

Intervention Type DEVICE

Standardised Exercise Prescription with the additional support of Virtual Reality Promoted Exercise Games.

Interventions

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Exercise Prescription

Standardised Exercise Prescription.

Intervention Type BEHAVIORAL

Exercise Prescription and Virtual Reality Exercise Gaming support

Standardised Exercise Prescription with the additional support of Virtual Reality Promoted Exercise Games.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Patients aged 18yrs and over.
3. Patient able to consent (with or without interpreter).
4. Patient able to undergo a general anaesthetic (seen by anaesthetist).

Exclusion Criteria

1. Patients referred for Revisional Bariatric Surgery.
2. Patients unable to use the Virtual Reality Gaming system.
3. Patient unable to consent.
4. Patients without a clear understanding of the English language.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Cornwall Hospitals Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Clark, FRCS PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Cornwall Hospitals NHS Trust

Locations

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Royal Cornwall Hospitals Trust

Truro, Cornwall, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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James Clark, FRCS PhD

Role: CONTACT

07958662710 ext. 07958662710

Mike Visick, PhD

Role: CONTACT

01872256430 ext. 56430

Facility Contacts

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Gina Townley

Role: primary

01872 256430 ext. 56430

Michael Visick, PhD

Role: backup

01872256430 ext. 56430

Other Identifiers

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2020.RCHT.08

Identifier Type: -

Identifier Source: org_study_id

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