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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG043392-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| University of St Thomas | UNKNOWN |
| National Institute on Aging (NIA) | NIH |
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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cycling exercise | Experimental | 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. |
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| Range of motion/stretching exercise | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang Yu, PhD | Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25304364 | Background | 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. | |
| 36461134 | Derived | Yu F, Han SY, Salisbury D, Pruzin JJ, Geda Y, Caselli RJ, Li D. Feasibility and preliminary effects of exercise interventions on plasma biomarkers of Alzheimer's disease in the FIT-AD trial: a randomized pilot study in older adults with Alzheimer's dementia. Pilot Feasibility Stud. 2022 Dec 2;8(1):243. doi: 10.1186/s40814-022-01200-2. |
| Label | URL |
|---|---|
| Study Listing at the Alzheimer's Association | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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| 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. |
|
| 34690736 | Derived | 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. |
| 33780529 | Derived | 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. |
| 28039287 | Derived | 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. |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |