Online Wellness Interventions for Cognitive Impairment

(MOTION Trial)

Overseen By Chelsea Leung, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Dementia medications, Psychoactive medications

Disqualifiers: Psychiatric disorders, Dementia, Disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different online wellness programs can boost physical and mental functions in adults with memory or thinking challenges. Participants will engage in one of three interventions: Health and Wellness Education, a gentle movement class combining various exercises (Preventing Loss of Independence through Exercise, or PLIE), or Tai Chi. Individuals who have noticed a gradual decline in memory or thinking abilities and have stable internet at home might be suitable candidates. Participants must be open to some in-person visits in California for assessments. As an unphased trial, this study offers a unique opportunity to explore innovative wellness programs that could enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot start or change any psychoactive medications during the study period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Gentle, Mindful Movement and Tai Chi are safe and well-tolerated methods to enhance thinking and memory. Studies indicate that meditation, a component of Gentle, Mindful Movement, can improve brain performance and health without harm. One study found that yoga, also part of this practice, is safe for adults with mild memory issues and may aid brain function and sleep.

For Tai Chi, research indicates it is safe and can enhance memory and thinking skills. Specifically, one study found Tai Chi to be more beneficial for brain function than walking. Over three years, Tai Chi has boosted memory and thinking in older adults.

These activities are generally considered safe, with no major side effects reported. This suggests minimal risk for participants, especially when guided by an instructor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to address cognitive impairment through online wellness interventions. Unlike traditional treatments that might involve medications or face-to-face therapy sessions, these interventions leverage online platforms, making them more accessible to a wider audience. The trial includes unique approaches like Tai Chi and a Gentle, Mindful Movement class, which combine elements from diverse exercise and mindfulness practices. These methods emphasize holistic wellness and might offer an alternative or complement to conventional treatments by focusing on enhancing both physical and mental well-being through easily accessible, live-streamed sessions.

What evidence suggests that this trial's treatments could be effective for cognitive impairment?

Research has shown that the Preventing Loss of Independence through Exercise (PLIÉ) program, a treatment in this trial, can improve physical and mental abilities and enhance the quality of life for people with cognitive challenges. Studies have found that PLIÉ participants experienced significant improvements in these areas. Meanwhile, Tai Chi, another treatment option in this trial, has been proven in several studies to enhance mental function. Specifically, one study discovered that after 24 weeks of Tai Chi, participants improved in overall mental abilities, including thinking speed and skills like planning and decision-making. Both PLIÉ and Tai Chi offer promising options for those facing memory and cognitive difficulties. ^{6 7 8 9 10}

Who Is on the Research Team?

Linda L Chao, PhD

Principal Investigator

University of California, San Francisco & SFVAHCS

Are You a Good Fit for This Trial?

Adults over 55 with mild cognitive impairment (MoCA score <26) and subjective memory complaints can join this trial. They must speak English, have internet at home, and be able to travel to specific California locations for assessments. Exclusions include severe disabilities, insufficient English proficiency, life expectancy concerns, other study participation, recent psychoactive medication changes or dementia diagnosis.

Inclusion Criteria

Montreal Cognitive Assessment (MoCA) score suggestive of Mild Cognitive Impairment (MCI) status (i.e., < 26)

I feel my thinking skills have gotten worse without a specific cause.

I am willing to travel to specific locations in California for study visits.

Exclusion Criteria

I have started or plan to start dementia medication recently.

I plan to start or change my mental health medication during the study.

I do not have any major psychiatric, recent unstable medical, or neurological conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in one of three online wellness interventions (Tai Chi, mindful movement, or health and wellness education) for 12 weeks, with sessions held twice a week.

12 weeks

24 sessions (online)

Follow-up

Participants are monitored for durability of cognitive and behavioral effects 6 months after the completion of the interventions.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Health and Wellness Education
• Preventing Loss of Independence through Exercise (PLIE)
• Tai Chi

Trial Overview The MOTION study is testing three online wellness programs: Health and Wellness Education, Tai Chi exercises, and PLIE training. These are aimed at improving physical function, cognition, and brain connectivity in older adults with memory or cognitive issues.

How Is the Trial Designed?

Group I: Tai Chi Experimental Treatment 1 Intervention

Participants will engage in 60-minute Tai Chi classes twice a week for 12 weeks. The classes will be live-streamed over the internet. Tai Chi is an ancient Chinese system of gentle physical exercise and stretching. It involves a series of movements performed in a slow, focused manner and accompanied by deep breathing.

Group II: Gentle, Mindful Movement Experimental Treatment 1 Intervention

Participants will engage in a gentle, mindful movement class twice a week for 12 weeks. The classes will be one hour long and will be live-streamed over the internet. The mindful movement classes will combine elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.

Group III: Health and Wellness Education Active Control 1 Intervention

Participants will engage in bi-weekly 60 minute sessions of Health and Wellness Education classes. The classes will be held on-line for 12 weeks.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

San Francisco VA Health Care System

Collaborator

Trials

11

Recruited

865,000+

Published Research Related to This Trial

Tai Chi (TC) exercise shows promise as a safe complementary therapy for managing cognitive impairment, but the evidence supporting its efficacy is currently of very low quality based on a review of 8 systematic reviews/meta-analyses.

All included studies had significant methodological flaws and reporting deficiencies, indicating a need for higher-quality research with better study designs and larger participant groups to validate the effectiveness of Tai Chi in cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence Quality Assessment of Tai Chi Exercise Intervention in Cognitive Impairment: An Overview of Systematic Review and Meta-Analysis. Shi, H., Dong, C., Chang, H., et al.[2022]

Tai chi (TC) is generally safe, with no serious adverse events reported in a review of 153 randomized controlled trials, primarily involving older adults, although minor musculoskeletal issues like knee and back pain were noted.

Only 33% of the trials reported adverse events, and just 12% had a clear protocol for monitoring them, indicating that the inconsistent reporting limits our understanding of TC's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. Wayne, PM., Berkowitz, DL., Litrownik, DE., et al.[2022]

A 12-week Tai Chi program for older adults with mild cognitive impairment (MCI) or dementia was found to be feasible and well-accepted, with an impressive attendance rate of 87% and no reported adverse events.

Participants with MCI showed significant improvements in grip strength and health-related quality of life, while both MCI and dementia groups improved their mobility as measured by the Timed Up and Go (TUG) test, indicating that Tai Chi can enhance physical functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 12-week Tai Chi program on physical function, depression, and quality of life among cognitively impaired older adults: a feasibility study. Oh, H., Song, R., Kim, SJ.[2023]

Tai Chi Chuan (TCC) significantly improved cognitive adaptations and reduced fear of movement in older adults with mild cognitive impairment, as shown by increased scores on relevant scales after 12 weeks of exercise.

The study, involving 20 participants who practiced TCC twice a week for 35-40 minutes, suggests that TCC can be safely implemented in nursing homes to enhance physical activity and cognitive status in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of Tai Chi Chuan on fear of movement, prevention of falls, physical activity, and cognitive status in older adults with mild cognitive impairment: A randomized controlled trial. Birimoglu Okuyan, C., Deveci, E.[2022]

The HABIT® program, which includes various interventions like wellness education and yoga, significantly improves quality of life and mood for individuals with mild cognitive impairment (pwMCI), especially when wellness education is included.

Cognitive training (CCT) was found to have the most substantial effect on cognitive function, while yoga improved functional status and reduced caregiver burden, suggesting that a combination of these interventions tailored to patient preferences could optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Interventions in Mild Cognitive Impairment (MCI): Lessons from a Multicomponent Program. Levy, SA., Smith, G., De Wit, L., et al.[2023]

A study involving 48 individuals with amnestic mild cognitive impairment found that both a combined intervention of Taoist Tai Chi (TTC) and a memory intervention program (MIP) and MIP alone improved memory strategy knowledge and everyday memory behaviors.

However, the addition of TTC did not provide any additional benefits for cognition, gait, or balance, suggesting that while both interventions were effective, TTC did not enhance the outcomes beyond those achieved with MIP alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taoist Tai Chi® and Memory Intervention for Individuals with Mild Cognitive Impairment. Fogarty, JN., Murphy, KJ., McFarlane, B., et al.[2017]

This systematic review will evaluate the effectiveness and safety of Tai Chi (TC) for individuals with mild cognitive impairment (MCI) by analyzing randomized controlled trials from various databases, covering studies published from January 1990 to March 2019.

The review aims to provide updated evidence on whether TC can improve cognitive function in MCI patients compared to placebo, conventional treatments, or no treatment, potentially highlighting TC as a beneficial intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai Chi for patients with mild cognitive impairment: A protocol for a systematic review and meta-analysis of randomized controlled trials. Yang, J., Chon, TY., Li, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8461710/

Preventing Loss of Independence through Exercise (PLIÉ) Although we hypothesized that PLIÉ may have a greater likelihood of slowing cognitive decline in individuals with less neurodegeneration (e.g., ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03526146

Preventing Loss of Independence Through Exercise (PLIÉ) ... Pilot study results suggest that PLIE is associated with meaningful improvements in physical function, cognitive function and quality of life in individuals ...

3. researchgate.net researchgate.net/publication/263934747_Preventing_Loss_of_Independence_through_Exercise_PLIE_A_Pilot_Clinical_Trial_in_Older_Adults_with_Dementia

A Pilot Clinical Trial in Older Adults with Dementia Conclusions: These qualitative results suggest that the PLIÉ program may be associated with beneficial functional, emotional, and social changes ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03526146/preventing-loss-of-independence-through-exercise-plie-in-persons-with-mild-cognitive-impairment-mci?activelyRecruiting=false&page=538&id=312&slug=dementia

Preventing Loss of Independence Through Exercise (PLIÉ) ... Pilot study results suggest that PLIE is associated with meaningful improvements in physical function, cognitive function and quality of life in ...

5. osher.ucsf.edu osher.ucsf.edu/research/current-research-studies/preventing-loss-independence-through-exercise-persons-dementia

Preventing Loss of Independence through Exercise in ... This study tests a novel, integrative exercise program for individuals with dementia called Preventing Loss of Independence through Exercise (PLIÉ).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162321/

Meditation for subjective cognitive decline, mild cognitive ... This meta-analysis suggests that meditation is an effective adjunct therapy for improving global cognitive performance, sleep quality, and health status in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6541218/

The effects of yoga on patients with mild cognitive ... Studies suggest that yoga is safe and feasible in adults with MCI and dementia, and may have beneficial effects on cognitive functioning, sleep, ...

8. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.976636/full

Mindfulness-based cognitive therapy vs. a health ... The proposed study will assess the clinical potential of MBCT to improve symptoms of depression, as well as examine its impact on cognitive impairments and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1877065725000739

Effects of mindfulness and exercise on cognition ... All 12-week, home-based interventions were delivered online, with 5 sessions per week. The primary outcomes included 3 cognitive and 2 mental health measures; ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05779137

The Effects of Mindfulness-based Cognitive Therapy in ... Also called a data safety and monitoring board, or DSMB. ... The sessions include meditation exercises (body-scan, sitting meditation, gentle movement ...