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

28 Participants Needed

Trial Summary

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 data supports the idea that Gentle Moves for Mild Cognitive Impairment and Dementia is an effective treatment?

The available research shows that exercise and activity-based treatments can be beneficial for people with mild cognitive impairment and dementia. For example, a study on a similar exercise program found that participants improved in their ability to stand on one leg and complete a simple walking test, which are indicators of better balance and mobility. This suggests that exercise programs like Gentle Moves could help improve physical abilities in people with these conditions. However, the research does not provide specific data on Gentle Moves itself, so more studies are needed to confirm its effectiveness. ^{1 2 3 4 5}

What safety data exists for Gentle Moves in treating mild cognitive impairment and dementia?

The research provided does not directly address the safety data for Gentle Moves specifically. However, it includes studies on dance movement interventions and exercise routines for individuals with mild cognitive impairment and dementia, which are related to Gentle Moves. These studies suggest that such interventions are feasible and may improve cognitive function and promote activity and independence, but specific safety data for Gentle Moves is not detailed in the provided research. ^{5 6 7 8 9}

Is Gentle Moves a promising treatment for mild cognitive impairment and dementia?

Gentle Moves could be a promising treatment because exercise and movement therapies have shown potential benefits for people with mild cognitive impairment and dementia. These therapies can help improve quality of life, balance, and social engagement, which are important for people with these conditions. ^{2 5 10 11 12}

What is the purpose of this trial?

The objective of the proposed study, "Promoting In-Home Activities at a Memory \& Aging Clinic (Pro-Home MeC)", is to assess and improve the feasibility of a physical activity (PA) intervention and the measurement of cognitive outcomes in a memory clinic setting for inactive older adults with mild cognitive impairment (MCI) or mild dementia and to examine how and improve the feasibility and acceptability of the procedures.

Eligibility Criteria

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

Fluent in English

I am 50 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Australia 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]

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

Fall risk-relevant functional mobility outcomes in dementia following dyadic tai chi exercise. [2022]

4. England 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. [2023]

5. England 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. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Assessment of balance in mild and moderate stages of Alzheimer's disease: implications on falls and functional capacity. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Motor function in subjects with mild cognitive impairment and early Alzheimer's disease. [2022]

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

Effects of a specially designed aerobic dance routine on mild cognitive impairment. [2022]

9. England 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. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The relative effectiveness of different types of exercise for people with Mild Cognitive Impairment or dementia: Systematic review protocol. [2021]

11. England 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. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Improvisational Movement to Improve Quality of Life in Older Adults With Early-Stage Dementia: A Pilot Study. [2022]