Gentle Moves for Mild Cognitive Impairment and Dementia

(Pro-Home MeC Trial)

Overseen By Naoko Muramatsu, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Illinois at Chicago

Disqualifiers: Major stroke, Severe hearing loss, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new physical activity program called "Gentle Moves" for individuals with mild cognitive impairment (MCI) or mild dementia. The researchers aim to assess the program's feasibility and acceptability and measure its effects on cognitive health. Participants will either engage in the Gentle Moves program or continue with their usual care. Ideal candidates are English-speaking individuals over 50, diagnosed with MCI or mild dementia, and not currently very active. As a Phase 1 trial, this research seeks to understand how the Gentle Moves program functions in people, offering participants the chance to be among the first to experience its potential benefits.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Gentle Moves intervention is safe for older adults with mild cognitive impairment or mild dementia?

Research has shown that physical activity benefits people with mild cognitive impairment (MCI) and dementia. Studies have found that exercise improves both physical and mental health. For instance, increased physical activity can lift mood and enhance physical abilities in older adults. This is important because staying active helps maintain both mental and physical well-being.

While the specific "Gentle Moves" program is still under evaluation, similar exercise programs have gained popularity among older adults. Participants often find these programs easy to follow and report positive outcomes. This suggests that Gentle Moves could also be safe and well-received.

This trial focuses on physical activity, which is generally considered safe. Similar exercise programs have not reported serious side effects, which should reassure potential participants about the safety of joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional medication-based treatments for mild cognitive impairment and dementia, like cholinesterase inhibitors or NMDA receptor antagonists, Gentle Moves focuses on a non-pharmacological approach. This treatment involves a three-month physical activity intervention, which is designed to engage patients in gentle exercises tailored to their abilities. Researchers are excited about Gentle Moves because physical activity has the potential to improve cognitive function and overall well-being without the side effects associated with drugs. The hope is that this intervention can offer a safer, more natural way to support cognitive health in those affected by these conditions.

What evidence suggests that Gentle Moves might be an effective treatment for mild cognitive impairment or mild dementia?

Research shows that gentle physical activities can help people with mild cognitive impairment (MCI) and dementia. Studies have found that these exercises improve balance, flexibility, and brain health. A review found that maintaining an exercise routine leads to many benefits, such as a better mood and improved physical abilities. Some research even suggests that significant lifestyle changes, like regular exercise, can greatly enhance thinking skills and daily activities over time. Overall, these activities hold promise for helping older adults with MCI or dementia stay independent and improve their mental abilities. Participants in this trial will either engage in the "Gentle Moves" physical activity intervention or continue with usual care provided by a neuropsychologist. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older who speak English and have been diagnosed with mild cognitive impairment (MCI) or mild dementia. They should be physically inactive, doing less than 150 minutes of planned exercise per week, and able to sit independently for at least 15 minutes. Those with significant mental or physical disabilities, severe hearing or vision loss, insufficient decision-making capacity, lack of safety awareness, current participation in similar research, or unwillingness to be assigned randomly can't join.

Inclusion Criteria

I can sit by myself in a chair for more than 15 minutes.

Fluent in English

Physically inactive (< 150 min/wk of planned PA)

Exclusion Criteria

I have a disability that makes it unsafe for me to do physical activities.

I have severe hearing or vision loss that is not treated.

I have difficulty recognizing safety hazards.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a three-month physical activity intervention called 'Gentle Moves'

12 weeks

In-home activities

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gentle Moves

Trial Overview The 'Pro-Home MeC' study tests a physical activity program called 'Gentle Moves' designed for older adults with MCI or mild dementia in a memory clinic setting. The goal is to see if the program is doable and liked by participants while also checking its effect on brain function.

How Is the Trial Designed?

Group I: Gentle Moves Experimental Treatment 1 Intervention

Three-month physical activity intervention.

Group II: Usual Care Active Control 1 Intervention

Usual care provided by neuropsychologist.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Patients with moderate Alzheimer's disease (AD) exhibited significantly poorer balance and functional capacity compared to those with mild AD and control subjects, indicating that balance declines as the disease progresses.

There is a correlation between balance impairment and falls in AD patients, but the loss of functional capacity does not directly relate to an increased risk of falls, suggesting that while balance is important, other factors may also contribute to fall risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of balance in mild and moderate stages of Alzheimer's disease: implications on falls and functional capacity. Kato-Narita, EM., Nitrini, R., Radanovic, M.[2022]

A 3-month aerobic dance routine significantly improved cognitive function in patients with mild cognitive impairment (MCI), particularly enhancing memory and processing speed, as shown by a study involving 60 participants.

The treatment group demonstrated a notable increase in memory scores and a decrease in P300 latency, indicating faster cognitive processing, compared to the control group receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a specially designed aerobic dance routine on mild cognitive impairment. Zhu, Y., Wu, H., Qi, M., et al.[2022]

A review of 30 systematic reviews found that physical exercise, particularly multimodal exercises, significantly improves daily living activities, walking, balance, and visual processing in individuals with dementia or mild cognitive impairment.

Engaging in regular exercise can enhance independence for cognitively impaired individuals, highlighting the importance of incorporating exercise into their care routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does physical exercise improve the capacity for independent living in people with dementia or mild cognitive impairment: an overview of systematic reviews and meta-analyses. Begde, A., Jain, M., Hogervorst, E., et al.[2023]

The PrAISED intervention, which involved up to 50 therapy sessions focusing on exercise and functional activities for adults with early dementia or mild cognitive impairment, did not show significant improvements in daily living activities, physical activity, or quality of life compared to usual care after 12 months.

Although the intervention group experienced fewer falls (79 falls) compared to the control group (200 falls), the difference was not statistically significant, indicating that the exercise program did not effectively reduce fall risk or improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. Harwood, RH., Goldberg, SE., Brand, A., et al.[2023]

This study aims to determine the most effective type of exercise for improving cognitive function in individuals with mild cognitive impairment (MCI) or dementia through a systematic review and network meta-analysis of various exercise types.

The findings will help guide clinical practices in nursing by identifying which specific domains of cognitive function respond best to different exercise interventions, ultimately optimizing therapy for patients with MCI or dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relative effectiveness of different types of exercise for people with Mild Cognitive Impairment or dementia: Systematic review protocol. Zhao, X., Huang, X., Li, B., et al.[2021]

A multi-centre randomized controlled trial (RCT) is being conducted to evaluate a novel intervention aimed at promoting activity and independence in 368 individuals with mild cognitive impairment (MCI) or early dementia, which may help slow cognitive decline and prevent falls.

The intervention includes up to 50 tailored exercise sessions delivered in participants' homes by trained professionals, and will assess various outcomes such as daily living activities, cognition, and quality of life, alongside a health economic evaluation to determine cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol. Bajwa, RK., Goldberg, SE., Van der Wardt, V., et al.[2021]

In a study of 140 older adults referred for cognitive symptoms, basic mobility and dual-task performance were found to be affected in individuals with very mild Alzheimer's disease (AD), but not in those with mild cognitive impairment.

Participants with Alzheimer's disease exhibited slower movement and challenges in performing cognitive tasks while walking, highlighting the impact of cognitive decline on motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor function in subjects with mild cognitive impairment and early Alzheimer's disease. Pettersson, AF., Olsson, E., Wahlund, LO.[2022]

Dance movement interventions (DMI) have been shown to significantly improve global cognition, memory, balance, and reduce depression in older adults with mild cognitive impairment (MCI), Alzheimer's disease (AD), and dementia, based on a review of 29 studies involving 1708 participants.

DMI is a non-pharmacological, effective, and engaging treatment option that can complement traditional therapies for cognitive decline in older adults, although it did not show significant effects on executive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of dance movement interventions for older adults with mild cognitive impairment, Alzheimer's disease, and dementia: A systematic scoping review and meta-analysis. Tao, D., Awan-Scully, R., Ash, GI., et al.[2023]

The StandingTall exercise program, delivered via tablet, was found to be feasible and safe for older adults with dementia, with a usability score of 68, indicating it met the target for usability.

Participants showed increasing adherence to the program over 12 weeks, with some exercising over 115 minutes by the end, and only one minor fall occurred without injury, suggesting the program is safe for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of a home-based fall prevention exercise program (StandingTall) delivered through a tablet computer (iPad) in older people with dementia. Taylor, ME., Close, JCT., Lord, SR., et al.[2022]

A 16-week dyadic Tai Chi exercise program was successfully completed by 86.4% of Alzheimer's disease (AD) patients, indicating high adherence and potential for safety in exercise interventions for this population.

Participants showed significant improvements in fall-risk-related functional mobility, with Unipedal Stance Time increasing from 4.0 to 5.6 seconds and Timed Up and Go times improving from 13.2 to 11.6 seconds, suggesting that Tai Chi may enhance mobility and reduce fall risk in individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fall risk-relevant functional mobility outcomes in dementia following dyadic tai chi exercise. Yao, L., Giordani, BJ., Algase, DL., et al.[2022]

The pilot study of the IMOVE trial involved 10 dyads (people with mild cognitive impairment or early-stage dementia and their caregivers) participating in an 8-week improvisational dance intervention, which showed promising increases in quality of life and balance.

Participants attended classes 96% of the time and reported feeling socially connected, while brain imaging indicated improvements in brain network characteristics, suggesting that dance may enhance cognitive and social engagement in individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvisational Movement to Improve Quality of Life in Older Adults With Early-Stage Dementia: A Pilot Study. Thumuluri, D., Lyday, R., Babcock, P., et al.[2022]

The six-week music-with-movement (MM) intervention showed greater improvements in memory and depressive symptoms among 58 nursing home residents with moderate dementia compared to those in music listening and social activity groups.

While the MM intervention appeared beneficial, the overall effects on cognitive functions did not significantly differ over time from the other interventions, suggesting more research is needed to confirm its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the music-with-movement intervention on the cognitive functions of people with moderate dementia: a randomized controlled trial. Cheung, DSK., Lai, CKY., Wong, FKY., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-dementia-2-2023-27109

Gentle Moves for Mild Cognitive Impairment and Dementia These studies suggest that such interventions are feasible and may improve cognitive function and promote activity and independence, but specific safety data ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7414005/

Adherence to exercise interventions in older people with mild ... Adherence to physical exercise is associated with multiple benefits in people with mild cognitive impairment (MCI) and dementia.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724006204

Lifestyle interventions for dementia risk reduction: A review ... These exercises involve gentle movements, offering benefits for balance, flexibility, and cognitive health [47]. Studies suggest that these traditional ...

4. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-024-01482-z

Effects of intensive lifestyle changes on the progression of ... Comprehensive lifestyle changes may significantly improve cognition and function after 20 weeks in many patients with MCI or early dementia due to AD.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2518041/

Exercise Interventions for Dementia and Cognitive Impairment Research evidence strongly suggests that increased physical exercise may not only improve physical function in older adults but may also improve mood and ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70696

A scoping review and comprehensive needs assessment for ... Mild cognitive impairment (MCI) is a high-risk state for dementia, marked by cognitive decline with preserved daily functioning.