Clinical trial NCT01954550: Effects of Aerobic Exercise for Treating Alzheimer's Disease
Official title: Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease, Late Onset
Keywords: Exercise
Dementia
Cognition
Brain Volume
Aging
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: University of St Thomas
name: National Institute on Aging (NIA)
First posted: 2013-10-01
Enrollment: 96
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in cognition from baseline to 6 months as measured by the Alzheimer's Disease Assessment Scale - Cognitive Subscale
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes:
measure: Change in hippocampal volume as measured by Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, 6 months, and 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Nursing
name: Fang Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yu F, Mathiason MA, Han S, Gunter JL, Jones D, Botha H, Jack C Jr. Mechanistic Effects of Aerobic Exercise in Alzheimer's Disease: Imaging Findings From the Pilot FIT-AD Trial. Front Aging Neurosci. 2021 Oct 7;13:703691. doi: 10.3389/fnagi.2021.703691. eCollection 2021.
citation: Greimel S, Wyman JF, Zhang L, Yu F. Recruitment and Screening Methods in Alzheimer's Disease Research: The FIT-AD Trial. J Gerontol A Biol Sci Med Sci. 2022 Mar 3;77(3):547-553. doi: 10.1093/gerona/glab092.
citation: Li D, Thomas R, Tsai MY, Li L, Vock DM, Greimel S, Yu F. Vascular biomarkers to predict response to exercise in Alzheimer's disease: the study protocol. BMJ Open. 2016 Dec 30;6(12):e011054. doi: 10.1136/bmjopen-2016-011054.