Effects of Aerobic Exercise for Treating Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2021-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer's Disease, Late Onset

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cycling exercise

Intervention Type 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

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.

Group Type SHAM_COMPARATOR

Range of motion/stretching exercise

Intervention Type 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.

Interventions

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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 Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No