Recruiting

Adaptive Exercises

Sponsor:

Arizona State University

Code:

NCT05877196

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Cognitive Impairment

Cognitive Decline

Memory Loss

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Moderate Intensity Continuous Training (MICT)

Chair-based Stretch

High-Intensity Interval Training (HIIT)

Combined Aerobic Resistance Exercise (CARE)

Study Details

Brief summary:

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.

Conditions

Mild Cognitive Impairment

Alzheimer Disease

Cognitive Impairment

Cognitive Decline

Memory Loss

Study ID

NCT05877196

Start date

Jun 22, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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

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

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Chair-based Stretch

Stretching while seated for 30-50 minutes, 3 times per week for 6 months.

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.

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.

Primary outcome measure

  • Peak oxygen consumption [ Time Frame: measured at 0 and 6 months ]
  • White Matter Hyperintensity volume [ Time Frame: measured at 0 and 6 months ]

Central Contacts and Locations

Central contacts

Kristi Spieleder, MS

480-884-2765kspieled@asu.edu

Locations

Arizona State University

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Kristi Spieleder, MS

480-884-2765kspieled@asu.edu

Principal Investigator:

Fang Yu, PhD

More Information

Sponsor

Arizona State University

Last update posted

May 5, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arizona State University on 2026-05-05.