Cognitive DeclineNCT06334328
Virtual Reality-based Mindful Movement Therapy for Seniors
A study testing Virtual reality based mindful movement therapy in people with Cognitive Decline and Physical Activity, run by Drexel University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Physical Activity, Psychological Wellbeing
- What is being tested?
- Virtual reality based mindful movement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel Universitsy
Philadelphia, Pennsylvania, 19102
About this study
Official title: 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.
Read the 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.
- Being tested
- Virtual reality based mindful movement therapy
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality based mindful movement therapyBehavioural
VR-MMT combines VR games, multisensory and cognitive stimulation, hand-eye and full body coordination, creative processes, expressive movement, mindfulness practice, and social connectedness.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality based mindful movement therapy | Experimental | 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. Receives: Behavioral: Virtual reality based mindful movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence
We will log participants' session attendance to track treatment adherence
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Throughout the intervention (week 1-week 6)
Secondary outcomes (7)
Montreal Cognitive Assessment (MoCA)
MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre and post intervention(Week 0 and Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start15 Aug 2022
- Primary completion30 Sep 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minjung Shim, PhD, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334328
- Sponsor's protocol ID
- 2205009237
- Status last verified
- Mar 2024
- First submitted
- 29 Jul 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Virtual Reality-based Mindful Movement Therapy for Older Adults
- ClinicalTrials.gov ID
- NCT06334328
- Acronym / sponsor ID
- 2205009237
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality based mindful movement therapy | Experimental | Behavioral: Virtual reality based mindful movement therapyParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality based mindful movement therapyVR-MMT combines VR games, multisensory and cognitive stimulation, hand-eye and full body coordination, creative processes, expressive movement, mindfulness practice, and social connectedness. | Behavioural | Virtual reality based mindful movement therapy |
Primary outcome
Treatment adherence
Time frame: Throughout the intervention (week 1-week 6)
We will log participants' session attendance to track treatment adherence
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.
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.
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.
Safety
Time frame: Throughout the intervention (week 1-week 6)
We will log adverse event to assess safety of the intervention
7 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: Pre and post intervention (Week 0 and Week 6)
Trail making test
Time frame: Pre and post intervention(Week 0 and Week 6)
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: Pre and post intervention(Week 0 and Week 6)
Physical Activity Scale for the Elderly (PASE)
Time frame: Pre and post intervention(Week 0 and Week 6)
Physical Performance Battery (SPPB)
Time frame: Pre and post intervention(Week 0 and Week 6)
General Self-Efficacy Scale
Time frame: Pre and post intervention(Week 0 and Week 6)
Positive Affect and Negative Affect Scale (PANAS)
Time frame: Pre and post intervention(Week 0 and Week 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality based mindful movement therapy in people with Cognitive Decline and Physical Activity, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence (time frame: Throughout the intervention (week 1-week 6)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.