Virtual Reality-based Mindful Movement Therapy for Seniors

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06334328
• Other study ID #: 2205009237
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Physical Activity
• Psychological Wellbeing

Intervention

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.

Locations

Country	Name	City	State
United States	Drexel Universitsy	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment adherence	We will log participants' session attendance to track treatment adherence	Throughout the intervention (week 1-week 6)
Primary	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)
Primary	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)
Primary	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)
Primary	Safety	We will log adverse event to assess safety of the intervention	Throughout the intervention (week 1-week 6)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)