Effects of Aerobic Exercise for Treating Alzheimer's Disease (FIT-AD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
Mayo Clinic
University of St Thomas
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01954550
First received: September 20, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

This randomized controlled trial (RCT) will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention on cognition and hippocampal volume in AD with three aims:

  • Determine the immediate effect of the cycling intervention on cognition in AD.
  • Examine if the cycling intervention slows cognitive decline in AD from baseline to 12 months.
  • Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using MRI.

The investigators will randomize 90 participants to the 6-month cycling or stretching/range of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6, and 12 months.


Condition Intervention
Alzheimer's Disease, Late Onset
Behavioral: Cycling exercise
Behavioral: Range of motion/stretching exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Baseline, 3 months, 6 months, 9 months, and 12 months ] [ Designated as safety issue: No ]
    This outcome measure will be given to all study participants.


Secondary Outcome Measures:
  • Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    Only participants who qualified to undergo MRI will be assessed for hippocampal volume.


Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cycling exercise
An exercise interventionist will guide and supervise participants to participate in moderate-intensity cycling on recumbent stationary cycles for 20-50 minutes, 3 times a week for 6 months.
Behavioral: Cycling exercise
An exercise interventionist will guide and supervise participants to participate in moderate-intensity cycling on recumbent stationary cycles for 20-50 minutes, 3 times a week for 6 months.
Sham Comparator: Range of motion/stretching exercise
An exercise interventionist will guide and supervise participants to participate in low-intensity range of motion/stretching exercise for 20-50 minutes, 3 times a week for 6 months.
Behavioral: Range of motion/stretching exercise
An exercise interventionist will guide and supervise participants to participate in low-intensity range of motion/stretching exercise for 20-50 minutes, 3 times a week for 6 months.

Detailed Description:

Aerobic exercise holds great promise for treating cognitive impairment, the hallmark symptom of Alzheimer's disease (AD), because it may attenuate brain atrophy. AD currently affects more than 5 million Americans, costing $203 billion in 2013 and causing poor outcomes such as loss of independence, low quality of life, and nursing home placement. Available drugs have only modest short-term effects on reducing or slowing cognitive impairment in AD. Hence, there is a pressing need to develop and test aerobic exercise interventions for AD. This randomized controlled trial (RCT) will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention on cognition and hippocampal volume in AD with three aims:

  • Determine the immediate effect of the cycling intervention on cognition in AD.
  • Examine if the cycling intervention slows cognitive decline in AD from baseline to 12 months.
  • Assess the effect of aerobic exercise on hippocampal volume in AD over 12 months using MRI.

The investigators will randomize 90 participants to the 6-month cycling or stretching/range of motion exercise (20-50-minute, 3 times a week). Participants will then be followed for another 6 months. Cognition will be assessed at baseline, 3, 6, 9, and 12 months and hippocampal volume will be measured using magnetic resonance imaging (MRI) at baseline, 6, and 12 months. Transportation will be provided to participants for all study-related activities including exercises. Participants who could not undergo MRI can still participate.

  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable or possible Alzheimer's disease (AD);
  • 15≤ Mini-Mental State Examination (MMSE) score ≤26;
  • Clinical Dementia Rating score 0.5-2;
  • Community-dwelling, e.g., homes and assisted living;
  • Age 66 years and older;
  • English-speaking;
  • Verified exercise safety by the primary care providers and the cardiologists if subjects have significant cardiac history;
  • Stable on AD drugs >1 month if AD drugs are prescribed.

Exclusion Criteria:

  • Resting heart rate (HR) ≤50 or ≥100 beats/min;
  • Neurological disorders in the past 5 years;
  • Psychiatric disorders in the past 5 years;
  • Alcohol or chemical dependency in the past 5 years;
  • Contraindications to exercise;
  • New symptoms or diseases that have not been evaluated by a health care provider, e.g., hip fracture, ongoing and unplanned weight loss, severe shortness of breath, deep vein thrombosis, hernia, unhealed sores, joint swelling, pain or trouble walking;
  • Cardiac ischemia or serious arrhythmia on the electrocardiograph during the screening exercise test.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954550

Contacts
Contact: Mary-Elizabeth Pasquesi, BS 6126269490 mpasques@umn.edu
Contact: Fang Yu, PhD 6126245435 yuxxx244@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Mary-Elizabeth Pasquesi, BS    612-626-9490    mpasques@umn.edu   
Contact: Fang Yu, PhD    6126245435    yuxxx244@umn.edu   
Principal Investigator: Fang Yu, PhD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Mayo Clinic
University of St Thomas
Investigators
Principal Investigator: Fang Yu, PhD Nursing
  More Information

Additional Information:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01954550     History of Changes
Other Study ID Numbers: 1R01AG043392-01A1
Study First Received: September 20, 2013
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Exercise
Dementia
Cognition
Brain Volume
Aging

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014