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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare the effects of three on-line wellness interventions for improving physical and cognitive function and brain connectivity in adults who are at least 55 years old and are experiencing symptoms of memory and/or cognitive difficulties.

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.

What data supports the effectiveness of the treatment 'Online Wellness Interventions for Cognitive Impairment'?

Research shows that Tai Chi, a component of the treatment, can improve physical function, reduce depression, and enhance quality of life in older adults with cognitive impairment. Additionally, wellness education, another component, has been found to positively impact mood and quality of life in people with mild cognitive impairment. ^{1 2 3 4 5}

Is Tai Chi safe for people with cognitive impairment?

Tai Chi is generally considered safe and is a gentle form of exercise recommended for people with various health conditions, including cognitive impairment. It has been studied for its effects on physical functioning, well-being, and quality of life, with no significant safety concerns reported in the research. ^{1 5 6 7 8}

How is the treatment 'Online Wellness Interventions for Cognitive Impairment' different from other treatments for cognitive impairment?

This treatment is unique because it combines online wellness education with physical activities like Tai Chi, which is a gentle exercise known to improve physical function and quality of life in people with cognitive decline. Unlike many treatments that focus solely on medication, this approach emphasizes holistic health and physical activity to support brain health. ^{1 4 9 10 11}

Research Team

Linda L Chao, PhD

Principal Investigator

University of California, San Francisco & SFVAHCS

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Tai chi and perceived health status in older adults who are transitionally frail: a randomized controlled trial. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral Interventions in Mild Cognitive Impairment (MCI): Lessons from a Multicomponent Program. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a Modified Tai Chi Program on Older People with Mild Dementia: A Randomized Controlled Trial. [2020]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effect of Tai Chi Chuan in reducing falls among elderly people: design of a randomized clinical trial in the Netherlands [ISRCTN98840266]. [2018]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Taoist Tai Chi® and Memory Intervention for Individuals with Mild Cognitive Impairment. [2017]

9. United States 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Evidence Quality Assessment of Tai Chi Exercise Intervention in Cognitive Impairment: An Overview of Systematic Review and Meta-Analysis. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

The effects of holistic health group interventions on improving the cognitive ability of persons with mild cognitive impairment: a randomized controlled trial. [2019]