About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
Moderate Intensity Continuous Training (MICT)
BehavioralAerobic 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
BehavioralStretching while seated for 30-50 minutes, 3 times per week for 6 months.
High-Intensity Interval Training (HIIT)
BehavioralAerobic 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)
Behavioral6 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.
Treatment groups
Trial outcomes
Primary outcomes
Peak oxygen consumption
VO2peak will be assessed from the symptom-limited peak cycle-ergometer test
White Matter Hyperintensity volume
WMH will be assessed from MRI.
Secondary outcomes
Memory
Wechsler Memory Scale - Revised; Logical Memory; score 0-50; higher scores indicate less impairment
Physical function
Short Physical Performance Battery: score 0-12; lower scores indicate poorer physical function
Behavioral and psychiatric symptoms of dementia (BPSD)
Neuropsychiatric Inventory Questionnaire; symptoms present, if yes, then severity and caregiver distress are reported.
Caregiver burden
4-item Zarit Burden Interview: score 0-16; higher scores reflect greater burden
Other outcomes
Dementia severity
Montreal cognitive Assessment: score 0-30; higher scores reflect less impairment
Executive function
Trail Making Test: number of seconds required to complete the task; therefore, higher scores reveal greater impairment
Visuospatial ability
Benson Complex Figure: score 0-17; higher scores reflect better visuospatial abilities.
Language preservation
Multilingual naming test: count the number of items correctly named; higher counts reflect better language preservation
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arizona State University
Lead sponsor
Banner Alzheimer's Institute
Collaborator