Bariatric SurgeryNCT04297306
Virtual Reality Exercise Gaming in Patients Awaiting Bariatric Surgery
A study testing Exercise Prescription and Exercise Prescription and Virtual Reality Exercise Gaming support in people with Bariatric Surgery and Prehabilitation, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bariatric Surgery, Prehabilitation
- What is being tested?
- Exercise Prescription and Exercise Prescription and Virtual Reality Exercise Gaming support
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Cornwall Hospitals Trust
Truro, Cornwall, TR1 3HD
Gina Townley, 01872 256430 ext. 56430, gina.townley@nhs.net
Michael Visick, PhD, 01872256430 ext. 56430, michael.visick@nhs.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Bariatric Surgery, Prehabilitation
- Being tested
- Exercise Prescription, Exercise Prescription and Virtual Reality Exercise Gaming support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise PrescriptionBehavioural
Standardised Exercise Prescription.
Exercise Prescription and Virtual Reality Exercise Gaming supportDevice
Standardised Exercise Prescription with the additional support of Virtual Reality Promoted Exercise Games.
| Study group | Role | What they receive |
|---|---|---|
| Exercise prescription | Active comparator | 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. Receives: Behavioral: Exercise Prescription |
| Exercise prescription and Virtual Reality Exercise Gaming | Experimental | 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. Receives: Device: Exercise Prescription and Virtual Reality Exercise Gaming support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity minutes using Activity tracker
Measured using Activity tracker
Measured: 6 weeks preoperatively
Calories Burnt using Activity Tracker
Measured using Activity tracker
Measured: 6 weeks preoperatively
Heart rate and Heart rate variability using Activity Tracker
Measured using Activity tracker
Measured: 6 weeks preoperatively
Complications at surgery using Clavien-Dindo Classification
Record of 90 day surgical complications
Measured: 90 days post operatively
Secondary outcomes (1)
Total excess Weight-loss post surgery (Kg)
Measurement of weight at postoperative consultations
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start14 Sep 2020
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case-controlled trial randomised, prospective trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Cornwall Hospitals Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Clark, FRCS PhD, Principal investigator, Royal Cornwall Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297306
- Sponsor's protocol ID
- 2020.RCHT.08
- Status last verified
- Jul 2022
- First submitted
- 27 Feb 2020
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality Exercise Games to Improve Prehabilitation Exercise Compliance in Patients Awaiting Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04297306
- Acronym / sponsor ID
- 2020.RCHT.08
- Conditions
- Bariatric Surgery, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Cornwall Hospitals TrustUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-controlled trial randomised, prospective trial
| Arm | Type | Receives |
|---|---|---|
| Exercise prescription | Active comparator | Behavioral: Exercise PrescriptionThis 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 | Experimental | Device: Exercise Prescription and Virtual Reality Exercise Gaming supportThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise PrescriptionStandardised Exercise Prescription. | Behavioural | Exercise prescription |
| Exercise Prescription and Virtual Reality Exercise Gaming supportStandardised Exercise Prescription with the additional support of Virtual Reality Promoted Exercise Games. | Device | Exercise prescription and Virtual Reality Exercise Gaming |
Primary outcome
Activity minutes using Activity tracker
Time frame: 6 weeks preoperatively
Measured using Activity tracker
Calories Burnt using Activity Tracker
Time frame: 6 weeks preoperatively
Measured using Activity tracker
Heart rate and Heart rate variability using Activity Tracker
Time frame: 6 weeks preoperatively
Measured using Activity tracker
Complications at surgery using Clavien-Dindo Classification
Time frame: 90 days post operatively
Record of 90 day surgical complications
1 secondary outcome
Total excess Weight-loss post surgery (Kg)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Clark, FRCS PhD principal investigator
Royal Cornwall Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Prescription and Exercise Prescription and Virtual Reality Exercise Gaming support in people with Bariatric Surgery and Prehabilitation, run by Royal Cornwall Hospitals Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Clark, FRCS PhD (07958662710 ext. 07958662710, james.clark10@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity minutes using Activity tracker (time frame: 6 weeks preoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.