Virtual Reality-based Mindful Movement Therapy for Seniors

Feasibility and Acceptability of Virtual Reality-based Mindful Movement Therapy for Older Adults

The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Cognitive Decline; Psychological Wellbeing
• Intervention / Treatment: Behavioral: Virtual reality based mindful movement therapy

Detailed Description

Age-related cognitive decline is a significant public health issue. Despite the benefit of regular physical activity in preserving cognitive function and overall health and wellbeing, approximately 30% of older adults are physically inactive due to a lack of motivation and other engagement barriers. Further, social isolation and loneliness are common in older adults which are associated with an increased risk of developing Alzheimer's disease (AD) and dementia. A combination of physical and cognitive training appears to be effective to improve cognitive function in older adults experiencing cognitive deterioration. Growing evidence suggests virtual reality(VR) is a promising tool to improve cognitive functioning in older adults. We have developed a novel virtual reality-based mindful movement therapy (VR-MMT) program for older adults that combines VR games, multisensory and cognitive stimulation, hand-eye and full body coordination, creative processes, expressive movement, mindfulness practice, and social connectedness. The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a VR-MMT protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. As this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach, it meets the definition of "innovative, high impact" research. Our specific aims include:

Aim 1: To develop (a) a technical platform and (b) an implementation plan for the delivery of a VR-MMT intervention for older adults. Technical development and implementation planning will be guided by the expert project team with key input from community stakeholders.

Aim 2: To conduct a clinical feasibility trial to examine the safety, feasibility, and preliminary efficacy (primary outcomes: cognitive function, psychological wellbeing, physical activity participation, secondary outcomes: mobility performance, loneliness, self-efficacy) of an 8-week VR-MMT intervention for older adults.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel Universitsy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects must be age 65 or older at the time of informed consent.
• Able to move and stand without assistance
• Subjects must be proficient in spoken and written English for consenting as well as for study participation
• Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
• Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
• Subject must have adequate hearing acuity as indicated by self-report.

Exclusion Criteria:

• Existing diagnosis of a neurodegenerative disorder (e.g., Alzheimer's Disease, Lewy Body Dementia, Frontal-Temporal Dementia).
• Prior diagnosis that might impact cognition and movement abilities including: cardiovascular or respiratory illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases (e.g., epilepsy, Parkinson's disease, seizure disorder).
• Affirmative answer to any Physical Activity Readiness Questionnaire for 70+ year-old adults (PAR-Q-70+) questionnaire.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual reality based mindful movement therapy; Participants will be asked to complete 12 VR-MMT sessions over a 6-week period, with two 30-minute sessions per week. Each session will be comprised of a guided warm-up (5 min, pre-recorded video played on the computer monitor) followed by a VR module with a head-mounted display (HMD) on (20 min). The VR module includes both structured and freestyle dance/movement guided by the therapist's prompts that are pre-recorded. Sessions will end with a closing routine (5 min, including guided breathing, stretching, and meditation) in order to assist participants to transition back to the real environment.

Behavioral: Virtual reality based mindful movement therapy; VR-MMT combines VR games, multisensory and cognitive stimulation, hand-eye and full body coordination, creative processes, expressive movement, mindfulness practice, and social connectedness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment adherence	We will log participants' session attendance to track treatment adherence	Throughout the intervention (week 1-week 6)
Treatment acceptability	Treatment Evaluation Inventory Short Form (post-intervention only) is a 9-item measure of the perceived acceptability of behavioral treatments. Items are rated on a 5-point scale with the anchor points 1 (strongly disagree) and 5 (strongly agree). Higher score meaning greater levels of treatment acceptability.	Post intervention (Week 6)
Treatment satisfaction	Usefulness, Satisfaction, and Ease of Use Questionnaire (post-intervention only) is a 30-item instrument that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. Each question is rated on a seven-point scale with the anchor points 1 (strongly disagree) and 7 (strongly agree). There are also two open-ended response questions asking the user to list the most negative aspects and the most positive aspects. All items are summed to give a total score, with higher scores indicating greater usability.	Post intervention (Week 6)
Qualitative feedback	A semi-guided individual interview (30 min) will be conducted upon the completion of the intervention to learn about participants' experience of participating in the study, perceived benefits, perceived barriers, and suggestions for improvement.	Post intervention (within 1-2 weeks after the conclusion of the 6-week intervention)
Safety	We will log adverse event to assess safety of the intervention	Throughout the intervention (week 1-week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation.	Pre and post intervention (Week 0 and Week 6)
Trail making test	Trail-Making Test is a measure of attention, speed, and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition.	Pre and post intervention(Week 0 and Week 6)
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)	WEMWBS is a 14-item scale of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health.	Pre and post intervention(Week 0 and Week 6)
Physical Activity Scale for the Elderly (PASE)	PASE is a 10-item scale that uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 - 793, with higher scores indicating greater physical activity.	Pre and post intervention(Week 0 and Week 6)
Physical Performance Battery (SPPB)	SPPB will be administered to assess mobility performance. SPPB is a group of measures that combines the results of gait speed, chair stand, and balance tests developed using data from a large population-based epidemiologic study of older persons. It consists of repeated chair stands, balance testing, and walking.	Pre and post intervention(Week 0 and Week 6)
General Self-Efficacy Scale	General Self-Efficacy Scale is a 10-item scale measuring self-efficacy, which has been correlated with positive emotion, optimism, and work satisfaction.	Pre and post intervention(Week 0 and Week 6)
Positive Affect and Negative Affect Scale (PANAS)	PANAS is a 20-item self-report measure of affect. The total score is calculated by finding the sum of the 10 positive items and the 10 negative items.	Pre and post intervention(Week 0 and Week 6)

Collaborators and Investigators

• Sponsor: Drexel University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2205009237

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