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Completed

NCT Number: NCT06334328

Virtual Reality-based Mindful Movement Therapy for Seniors

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel Universitsy

Philadelphia, Pennsylvania, 19102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality based mindful movement therapy

Behavioral

VR-MMT combines VR games, multisensory and cognitive stimulation, hand-eye and full body coordination, creative processes, expressive movement, mindfulness practice, and social connectedness.

Primary outcomes

  1. Treatment adherence

    Time frame: Throughout the intervention (week 1-week 6)

    We will log participants' session attendance to track treatment adherence

  2. Treatment acceptability

    Time frame: Post intervention (Week 6)

    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.

  3. Treatment satisfaction

    Time frame: Post intervention (Week 6)

    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.

  4. Qualitative feedback

    Time frame: Post intervention (within 1-2 weeks after the conclusion of the 6-week intervention)

    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.

  5. Safety

    Time frame: Throughout the intervention (week 1-week 6)

    We will log adverse event to assess safety of the intervention

Secondary outcomes

  1. Montreal Cognitive Assessment (MoCA)

    Time frame: Pre and post intervention (Week 0 and Week 6)

    MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation.

  2. Trail making test

    Time frame: Pre and post intervention(Week 0 and Week 6)

    Trail-Making Test is a measure of attention, speed, and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition.

  3. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    Time frame: Pre and post intervention(Week 0 and Week 6)

    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.

  4. Physical Activity Scale for the Elderly (PASE)

    Time frame: Pre and post intervention(Week 0 and Week 6)

    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.

  5. Physical Performance Battery (SPPB)

    Time frame: Pre and post intervention(Week 0 and Week 6)

    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.

  6. General Self-Efficacy Scale

    Time frame: Pre and post intervention(Week 0 and Week 6)

    General Self-Efficacy Scale is a 10-item scale measuring self-efficacy, which has been correlated with positive emotion, optimism, and work satisfaction.

  7. Positive Affect and Negative Affect Scale (PANAS)

    Time frame: Pre and post intervention(Week 0 and Week 6)

    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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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