A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses
NCT ID: NCT05877196
Last Updated: 2025-04-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
216 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-06-22
Study Completion Date
2028-06-30
Brief Summary
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The goal of this clinical trial is to test 6 months of aerobic exercise in older adults who are 65 years or older and have mild cognitive impairment (MCI) or probable/possible mild Alzheimer's Disease. The main questions it aims to answer are:
* test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes;
* identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and
* examines the mechanisms of aerobic exercise's action on memory in older adults with early AD.
Participants will receive 6 months of supervised exercise, undergo cognitive data collection and exercise testing 5 times over a year span, have an MRI brain scan 3 times over a one-year span, and have monthly follow-up discussions on health and wellness.
* test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes;
* identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and
* examines the mechanisms of aerobic exercise's action on memory in older adults with early AD.
Participants will receive 6 months of supervised exercise, undergo cognitive data collection and exercise testing 5 times over a year span, have an MRI brain scan 3 times over a one-year span, and have monthly follow-up discussions on health and wellness.
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Detailed Description
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The purpose of this Phase II, mechanistic Sequential, Multiple Assignment, Randomized Trial (SMART) is to test the effects of 6-month aerobic exercise on aerobic fitness and MRI and plasma biomarkers in community-dwelling older adults with early Alzheimer's disease (AD). The aims are to (I) test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes; (II) identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and (III) examines the mechanisms of aerobic exercise's action on memory in older adults with early AD. This trial builds on our previous work showing inter-individual differences in VO2peak responses to moderate-intensity continuous training (MICT); an ability of plasma neurofilament light chain (NfL) to predict cognition; and 6-month MICT maintained memory, reduced WMH, affected plasma p-tau181, and improved physical function, QoL, and caregiver distress. Aerobic exercise is a promising treatment for Alzheimer's disease (AD) and AD-related dementia (ADRD) but has shown mixed effects on cognition, physical function, behavioral and psychological symptoms of dementia (BPSD), quality of life (QoL), and caregiver burden. These findings are likely due to inter-individual differences in aerobic fitness responses, which have long been established in adults using VO2peak and were first reported in AD/ADRD by our team. Most AD/ADRD exercise trials did not measure VO2peak and those that reported large inter-individual differences in VO2peak responses to MICT. Mechanistically, animal studies support aerobic exercise modifying AD's ATN biomarkers (Amyloid-beta \[Aβ\], Tau, and Neurodegeneration), but human studies are few and have conflicting findings. Hence, precision exercise is critical to improving VO2peak responses with alternative interventions (high-intensity interval training (HIIT) or combined aerobic \& resistance exercise (CARE)). Because VO2peak can improve and peak from 3 months of MICT, 3 months is an ideal time to identify MICT non-responders and initiate HIIT or CARE.
Conditions
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Mild Cognitive Impairment
Alzheimer Disease
Cognitive Impairment
Cognitive Decline
Memory Loss
Memory Impairment
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Sequential, Multiple Assignment, Randomized Trial
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Study Groups
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Moderate Intensity Continuous Training (MICT)
Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months
Group Type
EXPERIMENTAL
Moderate Intensity Continuous Training (MICT)
Intervention Type
BEHAVIORAL
Aerobic cycling at a moderate intensity (50-75% of heart rate reserve) for 30-50 minutes, 3 times per week for 3-6 months.
Chair-based Stretch
Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months
Group Type
SHAM_COMPARATOR
Chair-based Stretch
Intervention Type
BEHAVIORAL
Stretching while seated for 30-50 minutes, 3 times per week for 6 months.
High-Intensity Interval Training (HIIT)
MICT for 3 months, and then cycling on recumbent stationary cycle at alternate high and moderate intensity for 40 minutes, 3 times per week for 3 months.
Group Type
ACTIVE_COMPARATOR
High-Intensity Interval Training (HIIT)
Intervention Type
BEHAVIORAL
Aerobic cycling at a vigorous intensity (80-90% of heart rate reserve 4-minute bouts with 4-minute recovery intervals) for 40 minutes, 3 times per week for 3 months.
Combined Aerobic Resistance Exercise (CARE)
MICT for 3 months, and then cycling on recumbent stationary cycle at moderate intensity for 30 minutes, followed by 20-minute strength-building exercise, 3 times per week for 3 months.
Group Type
ACTIVE_COMPARATOR
Combined Aerobic Resistance Exercise (CARE)
Intervention Type
BEHAVIORAL
6 full-body strength-building exercises followed by 30 minutes of MICT cycling (described above). Total duration is 60 minutes, 3 times per week for 3 months.
Interventions
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Moderate Intensity Continuous Training (MICT)
Aerobic cycling at a moderate intensity (50-75% of heart rate reserve) for 30-50 minutes, 3 times per week for 3-6 months.
Intervention Type
BEHAVIORAL
Chair-based Stretch
Stretching while seated for 30-50 minutes, 3 times per week for 6 months.
Intervention Type
BEHAVIORAL
High-Intensity Interval Training (HIIT)
Aerobic cycling at a vigorous intensity (80-90% of heart rate reserve 4-minute bouts with 4-minute recovery intervals) for 40 minutes, 3 times per week for 3 months.
Intervention Type
BEHAVIORAL
Combined Aerobic Resistance Exercise (CARE)
6 full-body strength-building exercises followed by 30 minutes of MICT cycling (described above). Total duration is 60 minutes, 3 times per week for 3 months.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Continuous Training
Aerobic exercise
Cardio
Stretch
Range of motion
flexibility
HIIT
Vigorous training
Hard exercise
Strength and Cardio Training
CARE
Combination training
Exercise training
Eligibility Criteria
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Inclusion Criteria
Participants:
* Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria.
* Community-dwelling, e.g., homes and assisted living
* Age 65 years and older
* Medical clearance from PCP or cardiovascular provider
* Have a qualified study partner
* Agree to the blood draws
* Verified MRI safety
Study Partner:
* Age 18 or older
* Contact with participant ≥ 2 times per week for ≥ 6 months
* Know the participant's memory status and ability to perform activities of daily living
* Consent to participant
* Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria.
* Community-dwelling, e.g., homes and assisted living
* Age 65 years and older
* Medical clearance from PCP or cardiovascular provider
* Have a qualified study partner
* Agree to the blood draws
* Verified MRI safety
Study Partner:
* Age 18 or older
* Contact with participant ≥ 2 times per week for ≥ 6 months
* Know the participant's memory status and ability to perform activities of daily living
* Consent to participant
Exclusion Criteria
Participants
* Resting HR ≤ 50 or ≥ 100 beats/min after 5-minutes of quiet resting
* American College of Sports Medicine contraindications to exercise
* New, unevaluated symptoms or diseases a healthcare provider has not evaluated
* Abnormal cardiac condition uncovered during VO2peak testing
* Enrollment in another intervention that aims at improving cognition
* Moderate to strenuous exercise ≥150 minutes a week in the previous 6 months
* ≥ 2 anti-depression medications, or poorly managed or unstable depression
* Poorly managed or unstable anxiety
Study partners:
* none
* Resting HR ≤ 50 or ≥ 100 beats/min after 5-minutes of quiet resting
* American College of Sports Medicine contraindications to exercise
* New, unevaluated symptoms or diseases a healthcare provider has not evaluated
* Abnormal cardiac condition uncovered during VO2peak testing
* Enrollment in another intervention that aims at improving cognition
* Moderate to strenuous exercise ≥150 minutes a week in the previous 6 months
* ≥ 2 anti-depression medications, or poorly managed or unstable depression
* Poorly managed or unstable anxiety
Study partners:
* none
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Banner Alzheimer's Institute
OTHER
Sponsor Role
collaborator
Arizona State University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Fang Yu, PhD
Role: PRINCIPAL_INVESTIGATOR
Arizona State University
Locations
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Arizona State University
Phoenix, Arizona, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Reference Type
BACKGROUND
Yu F, Todd M, Salisbury D, Maxfield M, Pruzin J, Joseph RP, Su Y, Li D, Baena E, Coon D. Precision exercise in older adults with early Alzheimer's disease: The study protocol of the FIT-AD Sequential, Multiple Assignment, Randomized Trial (SMART). Trials. 2025 Oct 15;26(1):416. doi: 10.1186/s13063-025-09040-0.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00017678
Identifier Type: -
Identifier Source: org_study_id
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