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VR-guided Exercise and Mindfulness Program for People with Chronic Pain

Virtual-reality-guided Exercise and Mindfulness Program for People with Chronic Pain Under Rehabilitation: a Randomised Controlled Cross-over Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06611566
Acronym
VRalgia
Enrollment
27
Registered
2024-09-25
Start date
2022-08-01
Completion date
2023-03-01
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Rehabilitation

Keywords

adult, humans, rehabilitation, virtual reality, chronic pain

Brief summary

In this study we assessed the feasibility of a VR-guided intervention seeking to improve physical fitness in individuals with chronic pain. In a randomised controlled trial with a cross-over design and participants in rehabilitation for chronic pain were asked to perform, in a counter-balanced order, five minutes of aerobic exercise following identical instructions given through either a VR headset or TV screen. The procedures were then repeated with mindfulness exercises. Heart rate (HR) was monitored throughout all four sessions and participants self-reported perceived exercise intensity, benefit, relaxation, and reward. Paired Student's t-test, Wilcoxon signed rank test and McNemar's test were performed to compare the outcome variables across sessions for individuals, as appropriate.

Detailed description

Participants: were recruited through partner patients' organizations, a local exercise group aimed at people living with rheumatological conditions, and an inpatient occupations rehabilitation centre. The study was conducted according to the Helsinki declaration and approved by the Local committee for medical and health research ethics at the Inland Norway University of Applied Sciences (Ref. 20616405). Study design The study was designed as a randomised controlled trial with a cross-over design. Intervntion: Each participant underwent five exercise sessions in total. Firstly, all participants performed a six- minutes warm-up session following instructions projected on a TV screen. Subsequently, the participants performed two aerobic exercise sessions, identical in content and duration (five- minutes), once following the instructions from VR (VR-A) and once following the identical program that was displayed on a TV screen (TV-A). The allocation of the first aerobic exercise session as VR-A or TV-A was randomly assigned for each individual. After completing the first aerobic exercise session, the participants were subsequently asked to complete the second session guided through the opposite mode of delivery. After the exercise sessions the same randomised cross-over design was followed for two five- minute mindfulness sessions, with the participants undergoing, in a counter-balanced and random order, a guided mindfulness program, once delivered through VR (VR-M) and once displayed on a TV screen (TV-M). Virtual environment and technology In the VR-A and VR-M, the participants wore a stand-alone HMD (Oculus Quest 2 with stock headstrap, Meta Platforms, Menlo Park, California, USA). The virtual environment was developed by Fynd Reality AS (Hamar, Norway), in line with general criteria outlined during the participatory process and consisted of a computer-generated replication of Hamar's town square (Norway). Each participant would enter this town square as a virtual avatar with virtual arms and body. The position of the arms was tracked by the hand-held controllers. A large screen would appear in the virtual town square, showing a video in which an instructor guided the exercises for the various sessions. This was the same video as shown on the TV screen. Data collection at baseline Participant were assessed according to the Polysymptomatic Distress Scale (PDS). The Widespread Pain Index and Symptom Scale that together compose thePDS were completed by participants. The PDS is composed of variables used in the 2010 American College of Rheumatology (ACR) fibromyalgia criteria which were later modified for use in clinical research and self-evaluation in epidemiological surveys 17-19. The PSD is thus both a diagnostic aid and a measure of fibromyalgia severity. A diagnosis of fibromyalgia may be indicated by a PSD score of 12 or more in an epidemiological study1. The PDS has been translated and validated in Norwegian 20. Outcome measures HR was registered throughout the sessions using a HR-monitors worn at the wrist (Garmin® Forerunner 55). The mean HRs for the last three minutes of each session were calculated for each individual. For the aerobic exercise sessions, HR was also categorised into HR-zones according to the ACSM recommendations based on the participants' predicted maximal HR (220 minus age) 4, with the proportion of time spent in moderate-vigorous exercise intensity (HR 65% of maximum heart rate or more) being calculated and used for further analysis. Participants also completed questionnaires Statistics We compared the mean HR values recorded within the last three minutes of the warm-up vs. all other sessions, as well between each aerobic exercise (VR-A vs. TV-A) and mindfulness sessions (VR-M vs. TV-M), using paired Student's t-test. The time spent in each HR category was compared using the paired Wilcoxon signed rank test and time in the moderate-vigorous vs low ACSM zone in the VR-A vs. TV-A sessions using McNemar's test for dichotomised variables. Comparisons between the self-reported measurements collected after the aerobic exercise (VR-A vs. TV-A) and mindfulness sessions (VR-M vs. TV-M) were performed using the paired Wilcoxon signed rank test for each session for ordinal data and McNemars test for dichotomised variables.

Interventions

BEHAVIORALVR-guided aerobic exercise

The intervention was 5 minutes of VR-guided aerobic exercise

BEHAVIORALVR-guided mindfulness exercise

The intervention was 5 minutes of VR-guided mindfulness exercise

BEHAVIORALTV-guided aerobic exercises

The intervention was 5 minutes of TV-guided aerobic exercises

BEHAVIORALTV-guided mindfulness exercises

The intervention was 5 minutes of VR-guided mindfulness exercises

Sponsors

The Research Council of Norway
CollaboratorOTHER
Inland Norway University of Applied Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Masking description

No masking was possible

Intervention model description

The studydesign was crossover and sequential. All participants tried VR- and TV- guided aerobic exercise and VR-and TV-guided mindfulness exercises, but in counterbalanced order

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The inclusion criteria were adults (>18 years of age) with chronic musculo-skeletal pain.

Exclusion criteria

* The

Design outcomes

Primary

MeasureTime frameDescription
Heart rateFor duration of interventions, an average of 30 minutes.HR was registered throughout the sessions using a HR-monitors worn at the wrist (Garmin® Forerunner 55). The mean HRs for the last three minutes of each session were calculated for each individual. For the aerobic exercise sessions, HR was also categorised into HR-zones according to the ACSM recommendations based on the participants' predicted maximal HR (220 minus age) 4, with the proportion of time spent in moderate-vigorous exercise intensity (i.e., HR > 65% of maximum heart rate) being calculated and used for further analysis.

Secondary

MeasureTime frameDescription
Perceived degree of relaxationAfter 10 minutesAfter each mindfulness sessions, the participants were asked to complete a short questionnaire regarding the degree of relaxation. The question was phrased as follow: How relaxing was the session? rated on a 5-point Likert scale ranging from 1 (least imaginable) to 5 (most imaginable).
Exercise intensityAfter 10 minutesParticipants self-reported exercise intensity after each aerobic sessions by completing a short paper questionnaire. The question was phrased as follow: How challenging was the session rated on a 5-point Likert scale ranging from 1 (least imaginable) to 5 (most imaginable).
Perceived rewardAfter 10 minutesAfter each mindfulness sessions, the participants were asked to complete a short questionnaire regarding the degree of perceived reward. The question was phrased as follow:How rewarding was the session? rated on a 5-point Likert scale ranging from 1 (least imaginable) to 5 (most imaginable).
Exercise adherenceAfter 10 minutesParticipants self-reported personal adherence directly after each aerobic sessions by completing a short paper questionnaire. The question was phrased as follow: How well did you exercise? rated on a 5-point Likert scale ranging from 1 (least imaginable) to 5 (most imaginable).

Other

MeasureTime frameDescription
Adverse events consequenceAfter 30 minutesParticipants were indicate correct phrase: I have to visit Accidents and Emergency department after the sessions/ I do not have to visit the Accidents and Emergency department after the sessions
Adverse events VR MildAfter30 minutesParticipants were asked to respond in text to following question: Did you dizziness , unsteady, too tired, excessive muscle ache while or after performing exercises with VR mask
Adverse events VR OthersAfter 30 minutesParticipants were asked to respond in text to following quetion: Did you fall, twist your ankle og hit the wall/other persones while wearing the mask?

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026