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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorArizona State University

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

216 Participants
are divided into 4 treatment groups
Group A: Moderate Intensity Continuous Training (MICT)Experimental treatment 1 intervention
Group B: Chair-based StretchSham comparator 1 intervention
Group C: High-Intensity Interval Training (HIIT)Active comparator 1 intervention
Group D: Combined Aerobic Resistance Exercise (CARE)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak oxygen consumption

VO2peak will be assessed from the symptom-limited peak cycle-ergometer test

Time frame
measured at 0 and 6 months
2

White Matter Hyperintensity volume

WMH will be assessed from MRI.

Time frame
measured at 0 and 6 months

Secondary outcomes

1

Memory

Wechsler Memory Scale - Revised; Logical Memory; score 0-50; higher scores indicate less impairment

Time frame
measured at 0, 6, and 12 months
2

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
3

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
4

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

Other outcomes

1

Dementia severity

Montreal cognitive Assessment: score 0-30; higher scores reflect less impairment

Time frame
measured at 0, 3, 6, 9, & 12 months
2

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
3

Visuospatial ability

Benson Complex Figure: score 0-17; higher scores reflect better visuospatial abilities.

Time frame
measured at 0, 3, 6, 9, & 12 months
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arizona State University

Lead sponsor

Banner Alzheimer's Institute

Collaborator