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

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery; Prehabilitation
• Intervention / Treatment: Behavioral: Exercise Prescription; Device: Exercise Prescription and Virtual Reality Exercise Gaming support

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Clark, FRCS PhD; Phone Number: 07958662710 07958662710; Email: james.clark10@nhs.net
• Study Contact Backup: Name: Mike Visick, PhD; Phone Number: 56430 01872256430; Email: michael.visick@nhs.net

Study Locations

• United Kingdom
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3HD
      • Recruiting
      • Royal Cornwall Hospitals Trust
      • Contact: Gina Townley; Phone Number: 56430 01872 256430; Email: gina.townley@nhs.net
      • Contact: Michael Visick, PhD; Phone Number: 56430 01872256430; Email: michael.visick@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Exercise Prescription; Standardised Exercise Prescription.
Experimental: 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.	Device: Exercise Prescription and Virtual Reality Exercise Gaming support; Standardised Exercise Prescription with the additional support of Virtual Reality Promoted Exercise Games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total excess Weight-loss post surgery (Kg)	Measurement of weight at postoperative consultations	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise pre-operatively only using Activity Tracker	Measurement of exercise taken	Each day for 4 weeks prior to surgery

Collaborators and Investigators

• Sponsor: Royal Cornwall Hospitals Trust
• Investigators: Principal Investigator: James Clark, FRCS PhD, Royal Cornwall Hospitals NHS trust

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020.RCHT.08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No