Clinical trial NCT06334328: Virtual Reality-based Mindful Movement Therapy for Seniors
Official title: Feasibility and Acceptability of Virtual Reality-based Mindful Movement Therapy for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Physical Activity
Psychological Wellbeing
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment adherence
timeFrame: Throughout the intervention (week 1-week 6)
measure: Treatment acceptability
timeFrame: Post intervention (Week 6)
measure: Treatment satisfaction
timeFrame: Post intervention (Week 6)
measure: Qualitative feedback
timeFrame: Post intervention (within 1-2 weeks after the conclusion of the 6-week intervention)
measure: Safety
timeFrame: Throughout the intervention (week 1-week 6)
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Pre and post intervention (Week 0 and Week 6)
measure: Trail making test
timeFrame: Pre and post intervention(Week 0 and Week 6)
measure: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: Pre and post intervention(Week 0 and Week 6)
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: Pre and post intervention(Week 0 and Week 6)
measure: Physical Performance Battery (SPPB)
timeFrame: Pre and post intervention(Week 0 and Week 6)
measure: General Self-Efficacy Scale
timeFrame: Pre and post intervention(Week 0 and Week 6)
measure: Positive Affect and Negative Affect Scale (PANAS)
timeFrame: Pre and post intervention(Week 0 and Week 6)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel Universitsy
state: Pennsylvania
Study officials:
References: