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Virtual Reality Therapy for Obesity (SPA-VR Trial)

N/A

Recruiting

Research Sponsored by Universite du Quebec en Outaouais

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after each virtual reality session (weeks 1, 2, 3, 4, 5,6 , 9 amd 12)

Awards & highlights

SPA-VR Trial Summary

This trialwill assess the feasibility and effects of VR-exposure and exercise on SPA, compliance, adherence and PA persistence in 45 women with obesity.

Who is the study for?

This trial is for women aged 18-45 with obesity (BMI ≥ 30 kg/m2) who are physically inactive and can visit Université du Québec en Outaouais twice a week. It's not for those pregnant, planning pregnancy, with past bariatric surgery, contraindications to exercise, motion sickness hypersensitivity, recent weight-influencing meds or physical activity programs, low SPA levels, intellectual disabilities or severe psychiatric issues.Check my eligibility

What is being tested?

The study tests if virtual reality exposure combined with exercise can reduce social physical anxiety in obese women. Forty-five participants will be randomly assigned to either an Exercise + VR group, an Exercise + psychological control group or a waiting list. The impact on adherence to exercise and long-term physical activity will also be evaluated.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing VR equipment like headaches or dizziness due to motion sickness (for those without hypersensitivity), as well as typical risks associated with starting an exercise regimen such as muscle soreness.

SPA-VR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before the intervention (baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before the intervention (baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before the intervention (baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the protocol and the intervention

Feasibility of the protocol and the intervention

Secondary outcome measures

Adherence to the physical activity (PA) intervention

Compliance with the PA intervention

Persistance in the practice of PA after the intervention

+2 more

Other outcome measures

Affects during exercise change (0-12 weeks)

Body Appreciation change (0-12 weeks)

Body composition change (0-12 weeks)

+13 more

SPA-VR Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Virtual reality and exerciceExperimental Treatment2 Interventions

This group will receive the exposure intervention in virtual reality and physical activity during 12 weeks

Group II: waiting listActive Control1 Intervention

This group will receive no intervention during 12 weeks, then will be randomized in the experimental or placebo group

Group III: Placebo and exercicePlacebo Group2 Interventions

This group will receive the placebo intervention (relaxation) and physical activity during 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Universite du Quebec en OutaouaisLead Sponsor

12 Previous Clinical Trials

865 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04630184 — N/A

Exercise Research Study Groups: Virtual reality and exercice, Placebo and exercice, waiting list

Exercise Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04630184 — N/A

Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630184 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is enrollment in this trial open?

"To be eligible for the trial, volunteers must possess obesity and fall in the 18-45 age range. 45 participants are sought after in total."

Answered by AI

What is the extent of participation in this research initiative?

"Yes, according to the data available on clinicaltrials.gov, this research project is actively searching for participants. This trial was initially posted on September 1st 2021 and has been updated as recently as October 31th 2022. The study aims to recruit 45 patients at a single location."

Answered by AI

Are there any spots available in this trial for new participants?

"As evidenced on clinicaltrials.gov, this research study is presently seeking applicants. The protocol was initially published on September 1st 2021 and most recently updated at the end of October 2022."

Answered by AI

Does this research protocol accept participants of twenty years or older?

"This clinical trial requires that prospective participants be aged between 18 and 45 years. There is a total of 225 studies available to minors and 679 for those above the retirement age."

Answered by AI

What is the main mission of this research endeavor?

"The main result this trial hopes to observe at the end of 36 weeks is participant acceptance of the protocol and intervention. Secondary objectives include tracking physical activity change through accelerometers, measuring adherence to PA interventions, as well as evaluating compliance with said interventions using heart rate monitors and diaries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity

Aurelie Baillot 2021. "A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04630184.