150 Participants Needed

High-Intensity Exercise for Alzheimer's Disease

(CYCLE-AD Trial)

SR
AR
Overseen ByAndrea Rohr, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not currently use Alzheimer's disease medications, including cholinesterase inhibitors and memantine. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study doctor.

What data supports the effectiveness of the treatment Indoor Cycling (IC), High-Intensity Interval Training (HIIT), Stationary Cycling, Home-Based Cycling, Peloton Cycling for Alzheimer's Disease?

Research suggests that exercise, including cycling, may help improve daily life activities, mental health, and physical fitness in people with Alzheimer's disease. While specific data on cycling is limited, general exercise has shown benefits in flexibility, balance, and some cognitive functions.12345

Is high-intensity exercise safe for people with Alzheimer's disease?

Exercise, including aerobic training, is generally safe for older adults with Alzheimer's disease, with studies showing it can improve fitness and cognitive function. It has fewer side effects and better adherence compared to medications.13678

How does the treatment of high-intensity exercise differ from other treatments for Alzheimer's disease?

High-intensity exercise, like indoor cycling, is unique because it focuses on improving brain health through physical activity, which can enhance blood flow to the brain and support brain cell growth, unlike medications that often have mixed effectiveness and more side effects.13479

What is the purpose of this trial?

The overall goal of the CYCLE-AD trial is to determine the role of long-term, high intensity exercise in slowing or delaying the onset of cognitive and AD-related brain changes in e4 carriers. Successful translation and demonstration of the effectiveness of a scalable home-based exercise intervention capable of slowing or delaying disease onset will transform AD treatment, improve patient outcomes and quality of life, and reduce health care costs.

Research Team

Jay Alberts, PhD | Cleveland Clinic

Jay L Alberts, PhD

Principal Investigator

The Cleveland Clinic

SR

Stephen Rao, PhD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

The CYCLE-AD trial is for healthy elders aged 65-80 with no cognitive impairment, carrying the APOE ε4 gene. Participants should be inactive (exercising less than three times a week), fluent in English, able to use a Peloton bike safely, and have in-home Wi-Fi. They must not have severe medical conditions or plan extensive travel during the study.

Inclusion Criteria

You need Wi-Fi at home to use the Peloton exercise system.
I do not plan to travel for more than 2 weeks during the study.
I can safely get on and off a stationary bike by myself.
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Exclusion Criteria

You are too heavy for your height, have metal objects in your body, are pregnant, or have a fear of being in small, enclosed spaces.
You have had problems with drinking too much alcohol or using drugs in the past 2 years.
You have a history of a certain type of mini-stroke or a high score on a scale that measures the risk of having a stroke.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in high-intensity interval training (HIIT) using the Peloton® cycling system or continue their habitual physical activity for 18 months

18 months
Regular home-based sessions, with assessments at study entry and 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cognitive testing and brain MR imaging

4 weeks

Treatment Details

Interventions

  • Indoor Cycling (IC)
Trial Overview This trial tests if long-term high-intensity indoor cycling can slow down or delay Alzheimer's-related brain changes in e4 carriers. It involves using a home-based Peloton exercise program to see if it can improve patient outcomes and reduce healthcare costs related to Alzheimer's Disease.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Indoor Cycling (IC)Experimental Treatment1 Intervention
Participants will engage in high-intensity interval training (HIIT; 60-90% of heart rate reserve) in their home via the commercially available Peloton® cycling system or 2) 3x/week (minimum 90 minutes/week) for 18 months.
Group II: Usual and Customary Care (UCC)Active Control1 Intervention
Participants engage in their habitual level of physical activity.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

University of Maryland, College Park

Collaborator

Trials
163
Recruited
46,800+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

A 2-month aerobic training program showed that older men with moderate Alzheimer's disease (AD) can improve their cardiorespiratory fitness, while those with severe AD may not benefit as much, indicating variability in response to exercise.
The study suggests that a longer duration of aerobic training, such as 6 months, may be more effective for improving fitness in older adults with AD, highlighting the need for tailored exercise programs based on individual fitness levels.
Aerobic training for older men with Alzheimer's disease: individual examples of progression.Yu, F., Leon, AS., Bliss, D., et al.[2021]
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.
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]
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.
Home-based multimodal exercise program in older people with Alzheimer disease: Randomized controlled trial protocol.Cezar, NOC., Ansai, JH., de Andrade, LP.[2021]

References

Aerobic training for older men with Alzheimer's disease: individual examples of progression. [2021]
Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. [2022]
Home-based multimodal exercise program in older people with Alzheimer disease: Randomized controlled trial protocol. [2021]
The effect of physical exercise on cerebral blood flow in Alzheimer's disease. [2021]
What are the Benefits of Exercise for Alzheimer's Disease? A Systematic Review of the Past 10 Years. [2018]
Need for Increased Promotion of Physical Activity Among Adults at Risk for Alzheimer's Disease: A Brief Report. [2022]
Alzheimer's Disease and Exercise: A Literature Review. [2017]
Relationship between physical activity, cognition, and Alzheimer pathology in autosomal dominant Alzheimer's disease. [2021]
Moderate-intensity intermittent exercise prevents memory deficit, hippocampal neuron loss, and elevated level of Alzheimer's dementia markers in the hippocampus of trimethyltin-induced rats. [2023]
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