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

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease, Cognitive Impairment

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Moderate Intensity Continuous Training (MICT)

Chair-based Stretch

High-Intensity Interval Training (HIIT)

Combined Aerobic Resistance Exercise (CARE)

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Moderate Intensity Continuous Training (MICT)

Chair-based Stretch

High-Intensity Interval Training (HIIT)

Combined Aerobic Resistance Exercise (CARE)

Arm Description

Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months

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

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.

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.

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Quality of Life (QoL)

Quality of Life - AD: score 0-52; higher scores reflect greater life satisfaction

Blood amyloid-beta 42 and 40

20 mL blood sample collection

Blood phosphorylated tau 181

20 mL blood sample collection

Blood total tau, neurofilament light chain

20 mL blood sample collection

Full Information

NCT ID

NCT05877196

First Posted

April 3, 2023

Last Updated

July 19, 2023

Sponsor

Arizona State University

Collaborators

Banner Alzheimer's Institute

1. Study Identification

Unique Protocol Identification Number

NCT05877196

Brief Title

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

Acronym

SMART

Official Title

Precision Medicine in Alzheimer's Disease: A SMART Trial of Adaptive Exercises and Their Mechanisms of Action Using AT(N) Biomarkers to Optimize Aerobic-Fitness Responses (The FIT-AD SMART Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

April 1, 2027 (Anticipated)

Study Completion Date

June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arizona State University

Collaborators

Banner Alzheimer's Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The purpose of this Phase II, mechanistic Sequential, Multiple Assignment, Randomized Trial (SMART) is to test the effects of 6-month aerobic exercise on aerobic fitness and MRI and plasma biomarkers in community-dwelling older adults with early Alzheimer's disease (AD). The aims are to (I) test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes; (II) identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and (III) examines the mechanisms of aerobic exercise's action on memory in older adults with early AD. This trial builds on our previous work showing inter-individual differences in VO2peak responses to moderate-intensity continuous training (MICT); an ability of plasma neurofilament light chain (NfL) to predict cognition; and 6-month MICT maintained memory, reduced WMH, affected plasma p-tau181, and improved physical function, QoL, and caregiver distress. Aerobic exercise is a promising treatment for Alzheimer's disease (AD) and AD-related dementia (ADRD) but has shown mixed effects on cognition, physical function, behavioral and psychological symptoms of dementia (BPSD), quality of life (QoL), and caregiver burden. These findings are likely due to inter-individual differences in aerobic fitness responses, which have long been established in adults using VO2peak and were first reported in AD/ADRD by our team. Most AD/ADRD exercise trials did not measure VO2peak and those that reported large inter-individual differences in VO2peak responses to MICT. Mechanistically, animal studies support aerobic exercise modifying AD's ATN biomarkers (Amyloid-beta [Aβ], Tau, and Neurodegeneration), but human studies are few and have conflicting findings. Hence, precision exercise is critical to improving VO2peak responses with alternative interventions (high-intensity interval training (HIIT) or combined aerobic & resistance exercise (CARE)). Because VO2peak can improve and peak from 3 months of MICT, 3 months is an ideal time to identify MICT non-responders and initiate HIIT or CARE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Sequential, Multiple Assignment, Randomized Trial

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Moderate Intensity Continuous Training (MICT)

Arm Type

Experimental

Arm Description

Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months

Arm Title

Chair-based Stretch

Arm Type

Sham Comparator

Arm Description

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

Arm Title

High-Intensity Interval Training (HIIT)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Combined Aerobic Resistance Exercise (CARE)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Moderate Intensity Continuous Training (MICT)

Other Intervention Name(s)

Continuous Training, Aerobic exercise, Cardio

Intervention Description

Aerobic cycling at a moderate intensity (50-75% of heart rate reserve) for 30-50 minutes, 3 times per week for 3-6 months.

Intervention Type

Behavioral

Intervention Name(s)

Chair-based Stretch

Other Intervention Name(s)

Stretch, Range of motion, flexibility

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

High-Intensity Interval Training (HIIT)

Other Intervention Name(s)

HIIT, Vigorous training, Hard exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Combined Aerobic Resistance Exercise (CARE)

Other Intervention Name(s)

Strength and Cardio Training, CARE, Combination training, Exercise training

Intervention Description

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 Information:

Title

Peak oxygen consumption

Description

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

Time Frame

measured at 0 and 6 months

Title

White Matter Hyperintensity volume

Description

WMH will be assessed from MRI.

Time Frame

measured at 0 and 6 months

Secondary Outcome Measure Information:

Title

Memory

Description

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

Time Frame

measured at 0, 6, and 12 months

Title

Physical function

Description

Short Physical Performance Battery: score 0-12; lower scores indicate poorer physical function

Time Frame

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

Title

Behavioral and psychiatric symptoms of dementia (BPSD)

Description

Neuropsychiatric Inventory Questionnaire; symptoms present, if yes, then severity and caregiver distress are reported.

Time Frame

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

Title

Caregiver burden

Description

4-item Zarit Burden Interview: score 0-16; higher scores reflect greater burden

Time Frame

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

Title

Quality of Life (QoL)

Description

Quality of Life - AD: score 0-52; higher scores reflect greater life satisfaction

Time Frame

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

Title

Blood amyloid-beta 42 and 40

Description

20 mL blood sample collection

Time Frame

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

Title

Blood phosphorylated tau 181

Description

20 mL blood sample collection

Time Frame

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

Title

Blood total tau, neurofilament light chain

Description

20 mL blood sample collection

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Dementia severity

Description

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

Time Frame

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

Title

Executive function

Description

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

Title

Visuospatial ability

Description

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

Time Frame

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

Title

Language preservation

Description

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

Title

Fall risk

Description

Timed up and Go: 3-meter course timed; time recorded in seconds; less time reflects lower fall risk

Time Frame

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

Title

Social interaction

Description

Engagement and Independence in Dementia Questionnaire: Scale - not true at all = 0, rarely true = 1, sometimes true = 2, often true = 3, true nearly all of the time = 4; higher ratings reflect more social interaction

Time Frame

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

Title

Anxiety

Description

Generalized Anxiety Disorder - 7: 0-21; lower scores reflect less anxiety

Time Frame

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

Title

Depression

Description

Geriatric Depression Scale: Score 1-15, lowers scores reflect less depression

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hector Cervantes, MS

Phone

602-496-2292

hcervant@asu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fang Yu, PhD

Organizational Affiliation

Arizona State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arizona State University

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hector Cervantes, MS

Phone

602-496-2292

hcervant@asu.ediu

First Name & Middle Initial & Last Name & Degree

Fang Yu, PhD

First Name & Middle Initial & Last Name & Degree

David Coon, PhD

First Name & Middle Initial & Last Name & Degree

Rodney Joseph, PhD

First Name & Middle Initial & Last Name & Degree

Michael Todd, PhD

First Name & Middle Initial & Last Name & Degree

Molly Maxfield, PhD

First Name & Middle Initial & Last Name & Degree

Jeremy Pruzin, MD

First Name & Middle Initial & Last Name & Degree

Yi Su, MD

First Name & Middle Initial & Last Name & Degree

Dereck Salisbury, PhD

First Name & Middle Initial & Last Name & Degree

Danni Li, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Investigators will create a de-identified dataset and de-identified bio-samples to share at the time of publishing the primary results of our trial or within 9 months of database lock, whichever comes first. The data to be shared include but not limited to: de-identified health history and covariate scores de-identified instrument item and total scores of primary and secondary outcomes de-identified exercise session report data de-identified bio-samples

IPD Sharing Time Frame

May 2027

IPD Sharing 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

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

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