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Adaptive Aerobic Exercise for Alzheimer's Disease (SMART Trial)
N/A
Recruiting
Led By Fang Yu, PhD
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 65 years and older
Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 0, 3, 6, 9, & 12 months
Awards & highlights
SMART Trial Summary
This trial tests 6 months of supervised aerobic exercise for people 65+ w/MCI or early Alzheimer's to assess aerobic fitness, WMH volume, and patient-centered outcomes. Participants receive exercise, cognitive testing, MRI scans, and monthly health discussions.
Who is the study for?
This trial is for adults aged 65 or older with mild cognitive impairment (MCI) or early Alzheimer's Disease. They need medical clearance, a study partner who knows their memory and daily living abilities, and must be living in the community. People can't join if they have certain heart conditions, are on multiple depression medications, do other cognition interventions, exercise heavily already, or have unmanaged anxiety.Check my eligibility
What is being tested?
The trial tests four types of exercises: Moderate Intensity Continuous Training (MICT), Chair-based Stretching, High-Intensity Interval Training (HIIT), and Combined Aerobic Resistance Exercise (CARE). It aims to see which improves aerobic fitness and memory over six months in older adults with MCI or mild Alzheimer's.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects from these exercises may include muscle soreness, fatigue, joint pain or discomfort especially if participants are not used to regular physical activity.
SMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
Select...
I have been diagnosed with mild cognitive impairment or early-stage Alzheimer's.
Select...
My study partner is 18 years old or older.
SMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 0 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 0 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak oxygen consumption
White Matter Hyperintensity volume
Secondary outcome measures
Behavioral and psychiatric symptoms of dementia (BPSD)
Blood amyloid-beta 42 and 40
Blood phosphorylated tau 181
+5 moreOther outcome measures
Anxiety
Dementia severity
Depression
+5 moreSMART Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Moderate Intensity Continuous Training (MICT)Experimental Treatment1 Intervention
Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months
Group II: High-Intensity Interval Training (HIIT)Active Control1 Intervention
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.
Group III: Combined Aerobic Resistance Exercise (CARE)Active Control1 Intervention
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.
Group IV: Chair-based StretchPlacebo Group1 Intervention
Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months
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Who is running the clinical trial?
Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
109,298 Total Patients Enrolled
Banner Alzheimer's InstituteOTHER
7 Previous Clinical Trials
2,468 Total Patients Enrolled
Fang Yu, PhDPrincipal InvestigatorArizona State University
2 Previous Clinical Trials
135 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.You have a heart condition found during a specific test for measuring your body's ability to use oxygen.You have been doing challenging exercise for at least 150 minutes per week in the last 6 months.I am aware of my memory status and can perform daily activities.I have tried at least 2 antidepressants or my depression is not well-controlled.You have symptoms or a new disease that a doctor has not checked yet.Criterion: You have medical reasons that make it unsafe for you to exercise, according to the American College of Sports Medicine.I have been diagnosed with mild cognitive impairment or early-stage Alzheimer's.My study partner is 18 years old or older.I have been in contact with the study team at least twice a week for six months or more.The participant's safety has been confirmed for MRI scans.You are currently taking part in another program to improve your thinking abilities.Your heart rate is too slow (less than 50 beats per minute) or too fast (more than 100 beats per minute) after resting for 5 minutes.You have anxiety that is not being well controlled or keeps changing.You live in a regular home or assisted living facility.
Research Study Groups:
This trial has the following groups:- Group 1: High-Intensity Interval Training (HIIT)
- Group 2: Combined Aerobic Resistance Exercise (CARE)
- Group 3: Moderate Intensity Continuous Training (MICT)
- Group 4: Chair-based Stretch
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study accepting new participants?
"Based on the information currently available to us through clinicaltrials.gov, this trial is not accepting participants at present. This project was posted on May 15th 2023 and last updated on May 25th of that same year; however there are 1,077 other trials actively recruiting volunteers as we speak."
Answered by AI
What are the intended outcomes of this experiment?
"This clinical research aims to evaluate White Matter Hyperintensity volume over the course of 6 months. Additionally, investigators will assess Physical function (Short Physical Performance Battery: 0-12; lower scores indicate poorer physical performance), Behavioral and psychiatric symptoms of dementia (Neuropsychiatric Inventory Questionnaire), as well as Caregiver burden (4-item Zarit Burden Interview)."
Answered by AI
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