Clinical Trial: Effects of Aerobic Exercise for Treating Alzheimer's Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: 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: Same as current

Current Secondary Outcome: 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: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: September 20, 2013
Date Started: March 2014
Date Completion: April 2019
Last Updated: November 9, 2016
Last Verified: November 2016