Physical Activity for Alzheimer's Disease

(RAATE-MCI Trial)

Overseen By Callie Hebert, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Dementia, Uncontrolled hypertension, Recent heart surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how physical activity affects risk factors for Alzheimer's Disease, specifically in older African American adults. Participants will join either a physical activity program or a group focused on low-intensity activities and healthy aging education. Ideal candidates are African American, 60 or older, physically able to exercise, and not currently active. The study will last 52 weeks and aims to provide insights into how staying active might aid in Alzheimer's prevention. As an unphased trial, this study offers a unique opportunity to contribute to important research on Alzheimer's prevention within the community.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that physical activity is safe and beneficial for brain health, particularly in older adults. Studies have found that regular exercise can enhance thinking, learning, and memory.

In some studies, individuals who exercised regularly had a lower risk of memory problems related to Alzheimer's disease, suggesting that physical activity might slow or delay memory issues.

Additionally, these studies report that participants generally express satisfaction with the exercise programs and maintain them for a year with few problems. This indicates that the exercises are easy to follow and do not cause major issues.

For those in the successful aging program, similar positive results have been observed. Regular physical activity, even simple activities like walking, is linked to maintaining brain health and may reduce the risk of developing Alzheimer's disease over time.

In summary, both programs emphasize physical activity, which appears safe and beneficial for the brain. They are designed to integrate into daily life without causing harm. For those considering joining a trial, these findings suggest that the activities are manageable and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Alzheimer's disease because they focus on physical and healthy lifestyle changes, which are different from the usual medication-based approaches like cholinesterase inhibitors or NMDA receptor antagonists. One approach involves a structured program of 150 minutes of physical activity per week, which is believed to potentially improve cognitive function and overall well-being. The other approach combines low-intensity activities with educational components on healthy aging, aiming to enhance quality of life through lifestyle changes. These methods represent a shift towards holistic, non-pharmacological strategies that could offer additional benefits without the side effects associated with drugs.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

Research has shown that physical activity can benefit people with Alzheimer's. Studies have found that exercise might improve the ability to perform daily tasks and maintain mental stability. Regular exercisers are up to 20% less likely to develop dementia, including Alzheimer's. In this trial, participants will join one of two treatment arms. The Physical Activity arm involves 150 minutes of physical activity weekly, which can enhance thinking skills and quality of life for those with Alzheimer's. The Successful Aging arm includes a low-intensity activity program and a healthy aging educational component. Even light activities can help keep the mind sharp and improve memory and decision-making. Both approaches suggest that regular exercise can slow mental decline. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert L Newton, Jr., PhD

Principal Investigator

Pennington Biomedical Research

Owen Carmichael, PhD

Principal Investigator

Pennington Biomedical Research

Are You a Good Fit for This Trial?

The RAATE-MCI trial is for African American adults aged 60 or older who self-identify as such, are willing to be randomly assigned to groups, can attend sessions and travel within the study area for a year. They must be physically able to exercise but not currently active, have mild cognitive impairment without severe dementia, and agree to data use after the study.

Inclusion Criteria

Physically capable of exercise

Free of conditions that would make regular exercise unsafe as deemed by the medical investigator

Willing to accept randomization

Exclusion Criteria

I am not willing to sign consent or be randomly assigned to a study group.

I am currently in a heart and lung rehab program.

My diabetes is not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either a physical activity intervention or a successful aging group for 52 weeks

52 weeks

Regular sessions at Pennington Biomedical or local community facilities

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physical activity program
• Successful Aging

Trial Overview This trial tests if physical activity affects Alzheimer's risk factors in older African Americans. Participants will either join a physical activity program or an active control group for one year. The goal is to see how exercise influences cognitive health compared with usual activities.

How Is the Trial Designed?

Group I: Successful Aging Experimental Treatment 1 Intervention

Low intensity activity program and a healthy aging educational component

Group II: Physical Activity Experimental Treatment 1 Intervention

150 minutes of physical activity weekly

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A home-based exercise program for patients with Alzheimer's Disease (AD) showed good adherence and a trend towards improved functional performance, particularly in hand function and lower extremity strength, after 6 and 12 weeks.

Despite the positive trends in functional performance, there were also indications of worse depression and lower quality of life ratings among participants, suggesting the need for further research to optimize the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a home-based exercise program in the treatment of Alzheimer's disease: the Maximizing Independence in Dementia (MIND) study. Steinberg, M., Leoutsakos, JM., Podewils, LJ., et al.[2022]

Exercise interventions have been shown to significantly improve physical fitness in community-dwelling adults with Alzheimer's disease, based on a review of 17 studies involving 1,068 participants.

While some studies indicated potential benefits for cognitive function, the evidence is less conclusive, highlighting the need for further research to confirm these effects and explore the mechanisms behind different types of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative review of exercise interventions among community-dwelling adults with Alzheimer's disease. Li, B., Liu, C., Wan, Q., et al.[2020]

A 12-month exercise program consisting of walking, strength, balance, and flexibility training significantly slowed the decline in the ability to perform activities of daily living (ADLs) in 134 patients with Alzheimer's disease compared to routine medical care.

The exercise program also improved physical performance, as evidenced by better 6-meter walking speed, with no adverse effects reported, highlighting its safety and potential benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise program for nursing home residents with Alzheimer's disease: a 1-year randomized, controlled trial. Rolland, Y., Pillard, F., Klapouszczak, A., et al.[2022]

Physical exercise may offer significant physical and mental benefits for individuals with Alzheimer's disease (AD), potentially addressing some of the metabolic and neuropathological changes associated with the condition.

The article reviews clinical studies that support the role of structured physical exercise programs in the treatment of AD, providing guidance on how to effectively prescribe these programs for older adults with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of physical exercise for older adults with Alzheimer's disease. Pérez, CA., Cancela Carral, JM.[2008]

In a randomized controlled trial involving 82 long-term care residents with Alzheimer's disease, an activity-specific exercise program significantly improved participants' ability to perform transfers compared to a walking program and an attention control group, which both showed declines.

This study suggests that targeted exercise interventions can enhance basic mobility skills in individuals with Alzheimer's disease, highlighting the potential for tailored physical activity to support functional independence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an activity specific exercise program for individuals with Alzheimer disease in long-term care settings. Roach, KE., Tappen, RM., Kirk-Sanchez, N., et al.[2021]

A home-based multimodal exercise program for 40 older adults with mild to moderate Alzheimer's disease is expected to improve muscle strength, balance, cognition, and overall functioning after 16 weeks of training.

The study aims to provide a foundation for future clinical interventions and health promotion strategies tailored for older individuals with Alzheimer's, highlighting the potential benefits of at-home exercise for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based multimodal exercise program in older people with Alzheimer disease: Randomized controlled trial protocol. Cezar, NOC., Ansai, JH., de Andrade, LP.[2021]

In a review of 63 articles from AARP magazines, only 3 English articles mentioned that physical activity (PA) could reduce the risk of Alzheimer's disease (AD), while no Spanish articles made this connection.

The study highlights a significant gap in cognitive health information in Spanish-language media, indicating a need for culturally relevant content to better inform diverse populations about the benefits of physical activity in relation to Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are older Latinos told about physical activity and cognition? A content analysis of a top-circulating magazine. Rose, ID., Friedman, DB., Marquez, DX., et al.[2021]

A 7-week physical exercise program for 23 elderly patients with Alzheimer's disease led to significant improvements in nutritional status and cognitive function, as measured by the MNA and MMS scales, respectively.

The program also resulted in a reduced risk of falls and fewer behavioral problems, suggesting that physical activity can be a beneficial therapeutic strategy for managing Alzheimer's disease complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility [corrected] of regular physical exercise for patients with moderate to severe Alzheimer disease. Rolland, Y., Rival, L., Pillard, F., et al.[2019]

A six-month home-based exercise program for 40 individuals with mild to moderate Alzheimer's disease was found to be feasible and safe, with 58% of participants completing the program without any reported adverse events.

Participants in the exercise group showed significant improvements in balance and mobility, as evidenced by a notable increase in Functional Reach and a reduction in falls risk compared to those in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial. Suttanon, P., Hill, KD., Said, CM., et al.[2022]

A systematic review of 13 randomized controlled trials involving 811 older adults with Alzheimer's disease found that multimodal exercise significantly improves activities of daily living (ADLs), suggesting it is beneficial for functional capacity in this population.

While multimodal exercise showed positive effects on ADLs, other types of exercise like aerobic and resistance training did not demonstrate significant improvements in mobility, muscle strength, or flexibility, highlighting the importance of tailored exercise programs for older adults with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of physical exercise at improving functional capacity in older adults living with Alzheimer's disease: a systematic review of randomized controlled trials. Braz de Oliveira, MP., Moreira Padovez, RFC., Serrão, PRMDS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11631704/

A meta-analysis of the efficacy of physical exercise ... The results showed that physical exercise might significantly improve ADL in Alzheimer's patients (SMD = 0.33, 95% CI: 0.12–0.54, I2 = 81.7%).

2. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724002693

Effectiveness of Physical Exercise on Alzheimer's disease. ... This study suggests a walking-based PE program can stabilize and slow down the progressive cognitive dysfunctions exhibited by individuals with AD and improve ...

3. nature.com nature.com/articles/s41598-023-44771-7

Effectiveness of exercise interventions to improve long ... A growing body of literature reports that exercise and physical activity (EXPA) can slow down the onset of dementia and prevent problems ...

4. alzheimers.org.uk alzheimers.org.uk/about-dementia/managing-the-risk-of-dementia/reduce-your-risk-of-dementia/physical-activity

Physical activity and the risk of dementia Research has shown that people who take regular exercise may be up to 20% less likely to develop dementia than those who don't take regular exercise.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8926300/

Effectiveness of Physical Activity Interventions on Cognition ... The overall results show that physical activity intervention can improve the cognition, neuropsychiatric symptoms and quality of life (Qol) of AD patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7498620/

Physical exercise in the prevention and treatment of ... Low levels of physical activity are a risk factor associated with Alzheimer's disease. Older adults who exercise are more likely to maintain cognition.

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/trc2.70115

The promotion of physical activity for use in Alzheimer's ... Participant retention at 12 months was 100%. Attendance at exercise and support/education sessions averaged ~85% and ~86%, respectively. Linear ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6130261/

Physical activity can improve cognition in patients with ... This meta-analysis and systematic review indicated that exercise intervention might improve the cognitive function of AD or slow down the decline of cognition.

9. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2024.1391611/full

The effect of physical exercise intervention on the ability ... According to clinical trials, physical exercise has shown a good impact on the functional and cognitive results of patients with AD (Kwak et al.

10. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224033994

The effectiveness of physical exercise interventions in ... The analysis of the results has shown that physical activity can inhibit or delay the emergence of severe NPS as the disease progresses. The difference in the ...