A SMART Trial of Adaptive Exercises to Optimize Aerobic-Fitness Responses

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Arizona State University
Study ID
NCT05877196
Status
Recruiting
Apply to this trial

Conditions

  • Alzheimer Disease
  • Cognitive Decline
  • Cognitive Impairment
  • Memory Impairment
  • Memory Loss
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 22, 2023
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Sham Comparator: Chair-based Stretch
    Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months
  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Peak oxygen consumption [ Time Frame: measured at 0 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arizona State UniversityPhoenixArizona85004
Kristi Spieleder, MS
[email protected]
480-884-2765
Fang Yu, PhD (PRINCIPAL_INVESTIGATOR)
David Coon, PhD (SUB_INVESTIGATOR)
Rodney Joseph, PhD (SUB_INVESTIGATOR)
Michael Todd, PhD (SUB_INVESTIGATOR)
Molly Maxfield, PhD (SUB_INVESTIGATOR)
Jeremy Pruzin, MD (SUB_INVESTIGATOR)
Yi Su, MD (SUB_INVESTIGATOR)
Dereck Salisbury, PhD (SUB_INVESTIGATOR)
Danni Li, PhD (SUB_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Arizona State University· Phoenix, AZ

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