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| Name | Class |
|---|---|
| Banner Alzheimer's Institute | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Intensity Continuous Training (MICT) | Experimental | Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months |
|
| Chair-based Stretch | Sham Comparator | Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months |
|
| High-Intensity Interval Training (HIIT) | Active Comparator | 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. |
|
| Combined Aerobic Resistance Exercise (CARE) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Intensity Continuous Training (MICT) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen consumption | VO2peak will be assessed from the symptom-limited peak cycle-ergometer test | measured at 0 and 6 months |
| White Matter Hyperintensity volume | WMH will be assessed from MRI. | measured at 0 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Memory | Wechsler Memory Scale - Revised; Logical Memory; score 0-50; higher scores indicate less impairment | measured at 0, 6, and 12 months |
| Physical function | Short Physical Performance Battery: score 0-12; lower scores indicate poorer physical function |
| Measure | Description | Time Frame |
|---|---|---|
| Dementia severity | Montreal cognitive Assessment: score 0-30; higher scores reflect less impairment | measured at 0, 3, 6, 9, & 12 months |
| Executive function | Trail Making Test: number of seconds required to complete the task; therefore, higher scores reveal greater impairment |
Inclusion Criteria:
Participants:
Study Partner:
Exclusion Criteria:
Participants
Study partners:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristi Spieleder, MS | Contact | 480-884-2765 | kspieled@asu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Fang Yu, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Recruiting | Phoenix | Arizona | 85004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25264466 | Background | Almirall D, Nahum-Shani I, Sherwood NE, Murphy SA. Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research. Transl Behav Med. 2014 Sep;4(3):260-74. doi: 10.1007/s13142-014-0265-0. | |
| 34492709 | Background | Salisbury D, Mathiason MA, Yu F. Exercise Dose and Aerobic Fitness Response in Alzheimer's Dementia: Findings from the FIT-AD Trial. Int J Sports Med. 2022 Sep;43(10):850-858. doi: 10.1055/a-1639-2307. Epub 2021 Sep 7. |
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Investigators will create a de-identified dataset and de-identified bio-samples to share at the time of publishing the primary results of our trial or within 9 months of database lock, whichever comes first. The data to be shared include but not limited to:
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May 2027
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Sequential, Multiple Assignment, Randomized Trial
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|
| Chair-based Stretch | Behavioral | Stretching while seated for 30-50 minutes, 3 times per week for 6 months. |
|
|
| High-Intensity Interval Training (HIIT) | 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) | 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. |
|
|
| measured at 0, 3, 6, 9, & 12 months |
| Behavioral and psychiatric symptoms of dementia (BPSD) | Neuropsychiatric Inventory Questionnaire; symptoms present, if yes, then severity and caregiver distress are reported. | measured at 1, 3, 6, 9, & 12 months |
| Caregiver burden | 4-item Zarit Burden Interview: score 0-16; higher scores reflect greater burden | measured at 1, 3, 6, 9, & 12 months |
| Quality of Life (QoL) | Quality of Life - AD: score 0-52; higher scores reflect greater life satisfaction | measured at 1, 3, 6, 9, & 12 months |
| Blood amyloid-beta 42 and 40 | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months |
| Blood phosphorylated tau 181 | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months |
| Blood total tau, neurofilament light chain | 20 mL blood sample collection | measured at 1, 3, 6, 9, & 12 months |
| measured at 0, 3, 6, 9, & 12 months |
| Visuospatial ability | Benson Complex Figure: score 0-17; higher scores reflect better visuospatial abilities. | measured at 0, 3, 6, 9, & 12 months |
| Language preservation | Multilingual naming test: count the number of items correctly named; higher counts reflect better language preservation | measured at 0, 3, 6, 9, & 12 months |
| Fall risk | Timed up and Go: 3-meter course timed; time recorded in seconds; less time reflects lower fall risk | measured at 0, 3, 6, 9, & 12 months |
| Social interaction | Engagement and Independence in Dementia Questionnaire: Scale - not true at all = 0, rarely true = 1, sometimes true = 2, often true = 3, true nearly all of the time = 4; higher ratings reflect more social interaction | measured at 0, 3, 6, 9, & 12 months |
| Anxiety | Generalized Anxiety Disorder - 7: 0-21; lower scores reflect less anxiety | measured at 0, 3, 6, 9, & 12 months |
| Depression | Geriatric Depression Scale: Score 1-15, lowers scores reflect less depression | measured at 0, 3, 6, 9, & 12 months |
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| 41094623 | Derived | 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. |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D016059 | Range of Motion, Articular |
| D018583 | Pliability |
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
| D064797 | Physical Conditioning, Human |
Not provided
Not provided