Effects of Aerobic Exercise for Treating Alzheimer's Disease

Alzheimer's Disease, Late Onset Clinical Trial

— FIT-AD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954550
• Other study ID #: 1306M356
• Secondary ID: 1R01AG043392-01A
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease, Late Onset

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Mayo Clinic, National Institute on Aging (NIA), University of St Thomas

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yu F, Bronas UG, Konety S, Nelson NW, Dysken M, Jack C Jr, Wyman JF, Vock D, Smith G. Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer's disease: study protocol of a randomized controlled trial (The FIT-AD trial). Trials. 2014 Oct 11;15:394. doi: 10.1186/1745-6215-15-394. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale	This outcome measure will be given to all study participants.	Baseline, 3 months, 6 months, 9 months, and 12 months
Secondary	Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI)	Only participants who qualified to undergo MRI will be assessed for hippocampal volume.	Baseline, 6 months, and 12 months

External Links

•   Study Listing at the Alzheimer's Association