RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2023-06-22
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05877196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria.
  2. * Community-dwelling, e.g., homes and assisted living
  3. * Age 65 years and older
  4. * Medical clearance from PCP or cardiovascular provider
  5. * Have a qualified study partner
  6. * Agree to the blood draws
  7. * Verified MRI safety
  8. * Age 18 or older
  9. * Contact with participant ≥ 2 times per week for ≥ 6 months
  10. * Know the participant's memory status and ability to perform activities of daily living
  11. * Consent to participant
  1. * Resting HR ≤ 50 or ≥ 100 beats/min after 5-minutes of quiet resting
  2. * American College of Sports Medicine contraindications to exercise
  3. * New, unevaluated symptoms or diseases a healthcare provider has not evaluated
  4. * Abnormal cardiac condition uncovered during VO2peak testing
  5. * Enrollment in another intervention that aims at improving cognition
  6. * Moderate to strenuous exercise ≥150 minutes a week in the previous 6 months
  7. * ≥ 2 anti-depression medications, or poorly managed or unstable depression
  8. * Poorly managed or unstable anxiety
  9. * none

Contacts and Locations

Study Contact

Hector Cervantes, MS
CONTACT
602-496-2292
hcervant@asu.edu

Principal Investigator

Fang Yu, PhD
PRINCIPAL_INVESTIGATOR
Arizona State University

Study Locations (Sites)

Arizona State University
Phoenix, Arizona, 85004
United States

Collaborators and Investigators

Sponsor: Arizona State University

  • Fang Yu, PhD, PRINCIPAL_INVESTIGATOR, Arizona State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-22
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2023-06-22
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

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