VR-guided Exercise and Mindfulness Program for People with Chronic Pain
VRalgia
Virtual-reality-guided Exercise and Mindfulness Program for People with Chronic Pain Under Rehabilitation: a Randomised Controlled Cross-over Trial
1 other identifier
interventional
27
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Aug 2022
Shorter than P25 for not_applicable chronic-pain
2 active sites
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
Study Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 9, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedSeptember 25, 2024
September 1, 2024
7 months
September 9, 2024
September 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart rate
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.
For duration of interventions, an average of 30 minutes.
Secondary Outcomes (4)
Exercise intensity
After 10 minutes
Perceived degree of relaxation
After 10 minutes
Perceived reward
After 10 minutes
Exercise adherence
After 10 minutes
Other Outcomes (3)
Adverse events VR Others
After 30 minutes
Adverse events VR Mild
After30 minutes
Adverse events consequence
After 30 minutes
Study Arms (4)
VR-guided aerobic exercise then TV-guided aerobic exercise
EXPERIMENTALParticipants were randomised to VR-guided aerobic exercise followed by TV-guided aerobic exercise
TV-guided exercise then VR-guided aerobic exercise
EXPERIMENTALParticipants were randomised toTV-guided aerobic exercise followed by VR- aerobic guided exercise
VR-guided mindfulness exercise then TV-guided mindfulness exercise
EXPERIMENTAL5 minutes of VR-guided mindfulness exercise followed by 5 minutes of TV-guided mindfulness exercise
TV-guided mindfulness exercise then VR-guided mindfulness exercise
EXPERIMENTAL5 minutes of TV-guided mindfulness exercise followed by 5 minutes of VR-guided mindfulness exercise
Interventions
The intervention was 5 minutes of VR-guided aerobic exercise
The intervention was 5 minutes of VR-guided mindfulness exercise
The intervention was 5 minutes of TV-guided aerobic exercises
The intervention was 5 minutes of VR-guided mindfulness exercises
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Inland Norway University of Applied Sciences
Elverum, Norway, 2406, Norway
Stiftelsen Hernes Institutt
Hernes, Norway, 2410, Norway
Related Publications (1)
Provan SA, Calogiuri G, Roset L, Mariussen M, Rosoy I, Johnsen TJ, Johansen T, Flaten OE, Litleskare S. VR-guided exercise and mindfulness program for people with chronic pain: a randomised controlled cross-over pilot trial. BMC Sports Sci Med Rehabil. 2025 Mar 21;17(1):55. doi: 10.1186/s13102-025-01102-9.
PMID: 40119474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sella A Provan, MD PHD
Inland Norway University of Applied Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking was possible
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2024
First Posted
September 25, 2024
Study Start
August 1, 2022
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
September 25, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share
We have not described sharing data from this small trial in the application to the ethical committe. If a relevant party was to ask for individual level data we would consider the application and consult the ethical committee.