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

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ClinicalTrials.gov Identifier: NCT01954550
Recruitment Status : Active, not recruiting
First Posted : October 1, 2013
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
Mayo Clinic
University of St Thomas
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Tracking Information
First Submitted Date  ICMJE September 20, 2013
First Posted Date  ICMJE October 1, 2013
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
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 ]
This outcome measure will be given to all study participants.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01954550 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, 6 months, and 12 months ]
Only participants who qualified to undergo MRI will be assessed for hippocampal volume.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Aerobic Exercise for Treating Alzheimer's Disease
Official Title  ICMJE Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease, Late Onset
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cycling exercise
  • 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.
    Intervention: Behavioral: Range of motion/stretching exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
96
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2013)
90
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 66 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01954550
Other Study ID Numbers  ICMJE 1R01AG043392-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE
  • Mayo Clinic
  • University of St Thomas
Investigators  ICMJE
Principal Investigator: Fang Yu, PhD Nursing
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP