Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-29 @ 8:09 AM
Study NCT ID:
NCT01954550
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2013-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aerobic Exercise for Treating Alzheimer's Disease
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Aerobic Exercise in Alzheimer's Disease: Cognition and Hippocampal Volume Effects
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIT-AD
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.
* 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01AG043392-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |