Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery
The Use of Virtual Reality Exercise Games to Improve Prehabilitation Exercise Compliance in Patients Awaiting Bariatric Surgery
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedAugust 2, 2022
July 1, 2022
2.6 years
February 27, 2020
July 29, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Activity minutes using Activity tracker
Measured using Activity tracker
6 weeks preoperatively
Calories Burnt using Activity Tracker
Measured using Activity tracker
6 weeks preoperatively
Heart rate and Heart rate variability using Activity Tracker
Measured using Activity tracker
6 weeks preoperatively
Complications at surgery using Clavien-Dindo Classification
Record of 90 day surgical complications
90 days post operatively
Secondary Outcomes (1)
Total excess Weight-loss post surgery (Kg)
18 months
Other Outcomes (1)
Exercise pre-operatively only using Activity Tracker
Each day for 4 weeks prior to surgery
Study Arms (2)
Exercise prescription
ACTIVE COMPARATORThis 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.
Exercise prescription and Virtual Reality Exercise Gaming
EXPERIMENTALThis 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.
Interventions
Standardised Exercise Prescription with the additional support of Virtual Reality Promoted Exercise Games.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Cornwall Hospitals Trust
Truro, Cornwall, TR1 3HD, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
James Clark, FRCS PhD
Royal Cornwall Hospitals NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 5, 2020
Study Start
September 14, 2020
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share