Sleep and Exercise for Alzheimer's Disease

(CASE Trial)

Recruiting at1 trial location

Overseen by Azizi A Seixas, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Exercise inability, Device use inability, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is studying whether better sleep and more exercise can reduce the risk of dementia in people who are at risk. The idea is that these lifestyle changes might help keep the brain healthy.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment for Alzheimer's disease?

Research shows that exercise can help improve daily life activities, mental health, and some cognitive functions in people with Alzheimer's disease. Exercise programs have been found to enhance physical fitness and may positively impact symptoms related to Alzheimer's. ^{1 2 3 4 5}

Is it safe for humans to use exercise and devices like the Dreem 2 Headband and Fitbit for Alzheimer's disease?

Exercise is generally safe for people with Alzheimer's disease and can improve daily life activities, mental health, and physical fitness. However, specific safety data for devices like the Dreem 2 Headband and Fitbit in this context is not provided in the available research. ^{1 6 7 8 9}

How does the exercise routine treatment for Alzheimer's differ from other treatments?

The exercise routine treatment for Alzheimer's is unique because it focuses on improving sleep quality and cognitive function through physical activity, rather than using medication. This approach leverages the benefits of exercise on sleep efficiency and overall health, which may help reduce the risk of Alzheimer's disease. ^{10 11 12 13 14}

Research Team

Azizi A Seixas, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals experiencing memory, concentration, or information processing issues who can do mild exercise and wear a DREEM 2 Headband and Fitbit watch. They must be able to handle a digital device and perform the Everlywell biomarker test. Participants should speak English and consent willingly.

Inclusion Criteria

I am mentally capable and agree to participate.

I can do the Everlywell biomarker test.

Able to Understand and Speak English

Exclusion Criteria

You are not allowed to do light exercise or have difficulty doing so.

Unable or unwilling to consent for any reason.

Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in sleep and/or exercise interventions for 12 weeks

12 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DREEM 2 Headband (Procedure)
• Exercise Routine (Behavioural Intervention)
• Fitbit (Behavioural Intervention)

Trial Overview The study examines how sleep quality and an exercise routine might influence dementia risk over time using tools like the DREEM 2 Headband to monitor sleep patterns and a Fitbit watch to track activity levels.

Participant Groups

Group I: Sleep Only Group Experimental Treatment 1 Intervention

Participants in this group will wear the DREEM 2 headband for 12 weeks.

Group II: Exercise Only Group Active Control 1 Intervention

Participants in this group will workout twice a week for 12 weeks.

Group III: Exercise and Sleep Group Active Control 2 Interventions

Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Dreem

Industry Sponsor

Trials

7

Recruited

280+

Shipley Foundation

Collaborator

Trials

1

Recruited

30+

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 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]

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]

This systematic review analyzed 23 studies on the effects of physical activity in Alzheimer's disease patients, but most studies did not provide clear evidence on how exercise impacts cognitive function or brain changes associated with the disease.

While the review suggests that there may be potential benefits of physical activity for Alzheimer's patients, it emphasizes the need for more rigorously designed studies to better understand this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of physical exercise on Alzheimer's disease. A sistematic review]. Agüera Sánchez, MÁ., Barbancho Ma, MÁ., García-Casares, N.[2021]

A systematic review of 8 randomized controlled trials involving 562 Alzheimer’s patients found that aerobic physical exercise, whether alone or combined with strength and balance training, can improve physical-functional capacity and cognitive performance in older adults with Alzheimer's disease.

The review also indicated moderate evidence that aerobic exercise can reduce neuropsychiatric symptoms and enhance quality of life for these patients, although results varied across studies and protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Physical Exercise on Alzheimer's disease. A Systematic Review. Cámara-Calmaestra, R., Martínez-Amat, A., Aibar-Almazán, A., et al.[2022]

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]

The psychomotor re-education guide (PSEG) significantly improved quality of life and physical fitness in 64 participants with Alzheimer's disease over a 12-month period.

While cognitive abilities declined due to disease progression, the PSEG was effective in enhancing physical capacity and overall well-being in patients with mild to moderate Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of a psychomotor re-education guide on the quality of life of patients with Alzheimer's disease]. Serdà I Ferrer, BC., Ortiz Collado, A., Avila-Castells, P.[2018]

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 multimodal exercise program over 6 months significantly improved sleep disturbances and performance in instrumental activities of daily living for patients with Alzheimer's and Parkinson's diseases, as shown in a study of 77 participants.

In contrast, control groups showed either maintenance or worsening of these conditions, highlighting the potential benefits of regular physical exercise for cognitive health in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a multimodal exercise program on sleep disturbances and instrumental activities of daily living performance on Parkinson's and Alzheimer's disease patients. Nascimento, CM., Ayan, C., Cancela, JM., et al.[2015]

A 12-week resistance training program significantly improved sleep efficiency and reduced sleep fragmentation in older adults, with 62 participants divided into a resistance training group and a control group.

These benefits were also observed in participants with mild cognitive impairment, suggesting that resistance training can be an effective intervention for enhancing sleep quality in older adults, potentially reducing risks associated with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of resistance training on sleep in Chinese older adults: A randomized controlled trial. Li, Z., Li, J., Yu, G., et al.[2021]

In a 12-week randomized controlled trial involving 72 older adults with sleep and cognitive complaints, low-intensity activities like stretching combined with educational content significantly improved self-reported sleep quality more than moderate- or high-intensity activities.

The stretching+educational DVD group saw an average improvement of 5.1 points in sleep quality scores, particularly in reducing nighttime awakenings and the use of sleep medications, highlighting the potential benefits of low-intensity interventions for sleep issues in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise and cognitive activity on self-reported sleep quality in community-dwelling older adults with cognitive complaints: a randomized controlled trial. Pa, J., Goodson, W., Bloch, A., et al.[2022]

The pilot study involving 37 inactive adults with insomnia showed that zero-time exercise (ZTEx) significantly reduced insomnia severity compared to sleep hygiene education, with a large effect size observed at weeks two, four, and six.

Although the initial benefits of ZTEx diminished by week eight, the training was well-received, with high adherence rates, indicating its potential as a feasible intervention for improving insomnia in inactive adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. Yeung, WF., Lai, AY., Ho, FY., et al.[2019]

In young adults, higher daily energy expenditure is associated with better sleep efficiency, but this relationship weakens in older adults, indicating age-related changes in how physical activity affects sleep.

A 12-month exercise training program improved physical fitness in older participants but did not lead to significant changes in sleep efficiency or other sleep characteristics, suggesting that exercise may be more beneficial for those with existing sleep issues rather than for healthy older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of physical fitness and daily energy expenditure on sleep efficiency in young and older humans. Oudegeest-Sander, MH., Eijsvogels, TH., Verheggen, RJ., 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. England 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. [2022]

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

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

4. Spain pubmed.ncbi.nlm.nih.gov

[Effect of physical exercise on Alzheimer's disease. A sistematic review]. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Physical Exercise on Alzheimer's disease. A Systematic Review. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Feasibility [corrected] of regular physical exercise for patients with moderate to severe Alzheimer disease. [2019]

7. Chile pubmed.ncbi.nlm.nih.gov

[Impact of a psychomotor re-education guide on the quality of life of patients with Alzheimer's disease]. [2018]

8. 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]

9. Japan pubmed.ncbi.nlm.nih.gov

Effect of a multimodal exercise program on sleep disturbances and instrumental activities of daily living performance on Parkinson's and Alzheimer's disease patients. [2015]

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

The effect of resistance training on sleep in Chinese older adults: A randomized controlled trial. [2021]

11. China pubmed.ncbi.nlm.nih.gov

Sleep disorders and exercise: a mini-review. [2023]

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

Effect of exercise and cognitive activity on self-reported sleep quality in community-dwelling older adults with cognitive complaints: a randomized controlled trial. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of Zero-time Exercise on inactive adults with insomnia disorder: a pilot randomized controlled trial. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of physical fitness and daily energy expenditure on sleep efficiency in young and older humans. [2022]