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Completed

NCT Number: NCT01954550

Effects of Aerobic Exercise for Treating Alzheimer's Disease

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.

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Key information

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cycling exercise

Behavioral

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.

Range of motion/stretching exercise

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Mayo Clinic
  • National Institute on Aging (NIA)
  • University of St Thomas

Registry information

Official study title

Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects

Acronym: FIT-AD

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2013
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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