Exercise for Alzheimer's Disease

(RAATE Trial)

Overseen By Melissa Harris, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 52 weeks

125 Participants Needed

Trial Summary

What is the purpose of this trial?

The RAATE proposal is designed to determine the effects of physical activity on risk factors for Alzheimer's Disease in older African American adults. The study will compare a physical activity program to an active control group. There are three main objectives of the protocol: 1) to determine if a physical activity intervention tailored to older African American adults is effective in modifying cognitive function associated with Alzheimer's Disease, 2) to determine if a physical activity intervention tailored to older African American adults is effective in modifying brain function and structure associated with Alzheimer's Disease, and 3) to determine if a physical activity promotion intervention tailored to African American adults is effective at enhancing physiological parameters. The primary endpoints for the study are episodic memory and executive functioning. The secondary outcomes include anthropometry, blood pressure, brain activation, cerebral blood flow, volume of whole brain and white matter hyperintensities, cardiorespiratory fitness, objectively measured physical activity, circulating hormones, and telomere length.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Physical activity, Exercise, Physical Exercise, Physical Activity, Successful Aging, Healthy Aging, Physical Activity Intervention for Alzheimer's Disease?

Research shows that exercise can help improve daily life activities, mental health, and some thinking skills in people with Alzheimer's disease. It may also enhance physical abilities like balance and strength, which are important for overall health. ^{1 2 3 4 5}

Is exercise safe for people with Alzheimer's disease?

The research does not provide specific safety data for exercise in people with Alzheimer's disease, but exercise is generally considered safe for most people and is known to reduce overall mortality and improve health. ^{5 6 7 8 9}

How does exercise as a treatment for Alzheimer's disease differ from other treatments?

Exercise for Alzheimer's disease is unique because it improves brain blood flow, increases brain volume, and enhances the growth of new brain cells, which can help improve memory and daily functioning. Unlike medications, exercise has fewer side effects and better adherence, making it a promising option for managing symptoms and slowing disease progression. ^{1 5 10 11 12}

Research Team

Robert L Newton, Jr., PhD

Principal Investigator

Pennington Biomedical Research Center

Owen Carmichael, PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

The RAATE trial is for African American adults aged 60 and older who are not currently exercising regularly. Participants must be physically able to exercise, willing to attend group sessions, and have no plans to move during the study. They should not have cognitive impairments that interfere with group interactions or any medical conditions that make regular exercise unsafe.

Inclusion Criteria

You are able to do physical activity.

Lacking plans to move during the study period

My physical ability score is 4 or higher.

Exclusion Criteria

You have health issues that make it hard for you to exercise regularly.

Conditions that the medical or principal investigator determine to warrant exclusion

I do not have any cognitive issues that would prevent me from participating in group activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into a physical activity promotion intervention or a healthy aging information group for 52 weeks

52 weeks

2 visits per week (in-person for supervised activity)

Follow-up

Participants are monitored for changes in cognitive function, brain structure, and other health parameters

4 weeks

Treatment Details

Interventions

• Physical activity
• Successful Aging

Trial Overview This trial tests if a physical activity program can affect risk factors for Alzheimer's Disease in older African Americans. It compares this program against an active control group, focusing on changes in cognitive function, brain structure and function, as well as physiological parameters like blood pressure and fitness levels.

Participant Groups

Group I: Physical activity intervention Experimental Treatment 1 Intervention

The intervention group will target 150 minutes of moderate to vigorous aerobic physical activity and two days of strength training, consistent with the current physical activity recommendations. Participants will engage in 2 days per week of supervised activity at community facilities. These participants will be requested to engage in an additional 30 minutes of moderate to vigorous aerobic physical activity two days per week at home.

Group II: Active control Active Control 1 Intervention

The active control group will be based on a low-intensity activity program and a healthy aging educational component. The physical activities will include stretching, balance training, flexibility, relaxation, and practicing activities of daily living. The successful aging education component will cover topics including avoiding scams, fall prevention, living wills, and dementia awareness.

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+

Findings from Research

A review of 14 studies on exercise and Alzheimer's disease found that exercise can significantly improve daily functioning and performance in patients, enhancing their ability to carry out daily activities.

Exercise also positively impacts neuropsychiatric symptoms and various cognitive functions, including sustained attention and visual memory, suggesting it may be a valuable intervention for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. Hernández, SS., Sandreschi, PF., da Silva, FC., et al.[2018]

A 12-week home-based physical activity program for 30 patients with Alzheimer's disease helped maintain their ability to perform daily activities, while the control group showed a decline in performance over the same period.

The intervention also led to improvements in cognitive functions, such as semantic word fluency and reaction time, and helped stabilize caregiver burden, suggesting that physical activity can be beneficial for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. Holthoff, VA., Marschner, K., Scharf, M., et al.[2022]

In a study of 357 older adults who developed Alzheimer's disease (AD), those who engaged in physical activity (PA) prior to diagnosis had a lower risk of mortality during the follow-up period of about 5.2 years.

While PA did not influence the rate of cognitive or functional decline in AD patients, higher levels of PA were associated with prolonged survival, suggesting that exercise may positively impact the course of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and Alzheimer disease course. Scarmeas, N., Luchsinger, JA., Brickman, AM., et al.[2021]

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]

A 16-week supervised aerobic exercise program for 200 patients with mild Alzheimer's disease did not show significant improvements in overall cognitive performance or quality of life compared to a control group.

However, the exercise program significantly reduced neuropsychiatric symptoms and showed potential cognitive benefits in patients who adhered closely to the exercise regimen, indicating that regular, intense exercise may help improve certain aspects of cognitive function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial. Hoffmann, K., Sobol, NA., Frederiksen, KS., et al.[2022]

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]

In a study of 91,298 older adults, vigorous physical activity (VPA) was found to significantly reduce Alzheimer's disease-related mortality, with optimal benefits observed at 140 minutes per week, potentially preventing up to 37,710 deaths annually in the U.S.

Moderate physical activity (MPA) did not show a significant association with Alzheimer's disease-related mortality, highlighting the greater importance of VPA for health outcomes in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate and vigorous leisure time physical activity in older adults and Alzheimer's disease-related mortality in the USA: a dose-response, population-based study. López-Bueno, R., Yang, L., Stamatakis, E., et al.[2023]

A year-long exercise program for patients with Alzheimer's disease (AD) showed that those participating in group-based or home-based exercise experienced slower deterioration in physical functioning compared to a control group receiving usual care.

The exercise groups also had significantly fewer falls and did not incur higher costs for health and social services, suggesting that intense exercise can be a safe and effective intervention for improving mobility in AD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Finnish Alzheimer disease exercise trial (FINALEX): a randomized controlled trial. Pitkälä, KH., Pöysti, MM., Laakkonen, ML., et al.[2022]

A meta-analysis of 29 studies with over 2 million participants found that physical activity significantly reduces the risk of developing Alzheimer's disease, with a hazard ratio of 0.72, indicating a 28% lower risk.

The protective effect of physical activity is strongest with moderate to vigorous intensity, showing a significant inverse relationship, while low-intensity activity did not demonstrate a protective effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical activity on risk of Alzheimer's disease: A systematic review and meta-analysis of twenty-nine prospective cohort studies. Zhang, X., Li, Q., Cong, W., et al.[2023]

Exercise can be an effective treatment for Alzheimer's disease (AD), showing improvements in cognitive function, reduced neuropsychiatric symptoms, and slower decline in daily activities, making it a valuable intervention alongside traditional medications.

Physical inactivity is a major preventable risk factor for developing AD, and higher levels of physical activity are linked to a lower risk of disease, highlighting the importance of exercise in both prevention and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's Disease and Exercise: A Literature Review. Cass, SP.[2017]

Resistance exercise is the most effective form of exercise for slowing cognitive decline in Alzheimer's patients, with a 72.4% likelihood of benefiting overall cognitive function.

Multi-component exercise is particularly effective for improving executive function, while resistance exercise is the only type that significantly impacts memory function, which is less responsive to exercise overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of various exercise interventions on cognitive function in Alzheimer's patients: A network meta-analysis. Lv, S., Wang, Q., Liu, W., et al.[2023]

In a study of 200 patients with mild Alzheimer's disease, those who carried the APOE ε4 genotype showed greater improvements in cognitive performance and physical measures from an exercise intervention.

The results suggest that the benefits of exercise in Alzheimer's patients may be influenced by their APOE genotype, indicating a potential avenue for personalized treatment strategies in managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with Alzheimer's disease who carry the APOE ε4 allele benefit more from physical exercise. Jensen, CS., Simonsen, AH., Siersma, V., et al.[2022]

References

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

What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. [2018]

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

Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Physical activity and Alzheimer disease course. [2021]

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

Benefits of physical exercise for older adults with Alzheimer's disease. [2008]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial. [2022]

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

What are older Latinos told about physical activity and cognition? A content analysis of a top-circulating magazine. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Moderate and vigorous leisure time physical activity in older adults and Alzheimer's disease-related mortality in the USA: a dose-response, population-based study. [2023]

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

Effects of the Finnish Alzheimer disease exercise trial (FINALEX): a randomized controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effect of physical activity on risk of Alzheimer's disease: A systematic review and meta-analysis of twenty-nine prospective cohort studies. [2023]

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

Alzheimer's Disease and Exercise: A Literature Review. [2017]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of various exercise interventions on cognitive function in Alzheimer's patients: A network meta-analysis. [2023]

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

Patients with Alzheimer's disease who carry the APOE ε4 allele benefit more from physical exercise. [2022]