An interventional study of Moderate Intensity Continuous Training (MICT) and Chair-based Stretch in Mild Cognitive Impairment, Alzheimer Disease and Cognitive Impairment, sponsored by Arizona State University. Recruiting at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Arizona State University · Not applicable, Interventional, and Treatment
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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This study's planned enrollment of 216 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
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Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months
Behavioral: Moderate Intensity Continuous Training (MICT)
Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months
Behavioral: Chair-based Stretch
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.
Behavioral: High-Intensity Interval Training (HIIT)
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.
Behavioral: Combined Aerobic Resistance Exercise (CARE)
Aerobic cycling at a moderate intensity (50-75% of heart rate reserve) for 30-50 minutes, 3 times per week for 3-6 months.
Also known as: Continuous Training, Aerobic exercise, Cardio
Stretching while seated for 30-50 minutes, 3 times per week for 6 months.
Also known as: Stretch, Range of motion, flexibility
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.
Also known as: HIIT, Vigorous training, Hard exercise
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.
Also known as: Strength and Cardio Training, CARE, Combination training, Exercise training
Peak oxygen consumption
VO2peak will be assessed from the symptom-limited peak cycle-ergometer test
Time frame: measured at 0 and 6 months
White Matter Hyperintensity volume
WMH will be assessed from MRI.
Time frame: measured at 0 and 6 months
Memory
Wechsler Memory Scale - Revised; Logical Memory; score 0-50; higher scores indicate less impairment
Time frame: measured at 0, 6, and 12 months
Physical function
Short Physical Performance Battery: score 0-12; lower scores indicate poorer physical function
Time frame: 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.
Time frame: measured at 1, 3, 6, 9, & 12 months
Caregiver burden
4-item Zarit Burden Interview: score 0-16; higher scores reflect greater burden
Time frame: 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
Time frame: measured at 1, 3, 6, 9, & 12 months
Blood amyloid-beta 42 and 40
20 mL blood sample collection
Time frame: measured at 1, 3, 6, 9, & 12 months
Blood phosphorylated tau 181
20 mL blood sample collection
Time frame: measured at 1, 3, 6, 9, & 12 months
Blood total tau, neurofilament light chain
20 mL blood sample collection
Time frame: measured at 1, 3, 6, 9, & 12 months
Dementia severity
Montreal cognitive Assessment: score 0-30; higher scores reflect less impairment
Time frame: 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
Time frame: measured at 0, 3, 6, 9, & 12 months
Visuospatial ability
Benson Complex Figure: score 0-17; higher scores reflect better visuospatial abilities.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: measured at 0, 3, 6, 9, & 12 months
Anxiety
Generalized Anxiety Disorder - 7: 0-21; lower scores reflect less anxiety
Time frame: measured at 0, 3, 6, 9, & 12 months
Depression
Geriatric Depression Scale: Score 1-15, lowers scores reflect less depression
Time frame: measured at 0, 3, 6, 9, & 12 months
Plan to share: Yes — 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: de-identified health history and covariate scores de-identified instrument item and total scores of primary and secondary outcomes de-identified exercise session report data de-identified bio-samples
Time frame: May 2027
Access criteria: a commitment to using the data only for research purposes and not to identify an individual participant a commitment to securing the data using appropriate computer technology a commitment to destroying or returning the data after analyses are completed all data sharing requests must be reviewed and approved by the PI
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