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

NCT05877196 | Recruiting DMC

• 1 other identifier: STUDY00017678
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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; Memory Impairment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Memory

  measured at 0, 6, and 12 months

• Physical function

  measured at 0, 3, 6, 9, & 12 months

• Behavioral and psychiatric symptoms of dementia (BPSD)

  measured at 1, 3, 6, 9, & 12 months

• Caregiver burden

  measured at 1, 3, 6, 9, & 12 months

• Quality of Life (QoL)

  measured at 1, 3, 6, 9, & 12 months

Other Outcomes (8)

• Dementia severity

  measured at 0, 3, 6, 9, & 12 months

• Executive function

  measured at 0, 3, 6, 9, & 12 months

• Visuospatial ability

  measured at 0, 3, 6, 9, & 12 months

Study Arms (4)

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

Behavioral: Moderate Intensity Continuous Training (MICT)

Chair-based Stretch

SHAM COMPARATOR

Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months

Behavioral: Chair-based Stretch

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.

Behavioral: High-Intensity Interval Training (HIIT)

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.

Behavioral: Combined Aerobic Resistance Exercise (CARE)

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.

Also known as: Continuous Training, Aerobic exercise, Cardio

Moderate Intensity Continuous Training (MICT)

Chair-based Stretch BEHAVIORAL

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

Also known as: Stretch, Range of motion, flexibility

Chair-based Stretch

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.

Also known as: HIIT, Vigorous training, Hard exercise

High-Intensity Interval Training (HIIT)

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.

Also known as: Strength and Cardio Training, CARE, Combination training, Exercise training

Combined Aerobic Resistance Exercise (CARE)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Banner Alzheimer's Institute: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

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  PMID: 41094623 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Memory Disorders

Interventions

Exercise; Range of Motion, Articular; Pliability; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Mechanical Phenomena; Physical Phenomena; Physical Conditioning, Human

Study Officials

• Fang Yu, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristi Spieleder, MS

CONTACT

480-884-2765; kspieled@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential, Multiple Assignment, Randomized Trial

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 26, 2023
• Study Start: June 22, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• 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

Locations

US (1)