Effects of a Bicycling Intervention on Cognitive Skills and Cardiovascular Health
BIKE
1 other identifier
interventional
33
1 country
1
Brief Summary
Although exercise is known to delay cognitive decline and decrease our risk of Alzheimer's Disease, there is a lack of understanding of how exercise protects the aging brain. The proposed research takes a novel approach to this problem by testing the concept that there are acute, direct effects of exercise in the same brain regions that are affected by chronic exercise training. If the investigators are successful, the acute paradigm will allow us to determine the critical exercise parameters that modulate brain function in humans using only a single exercise dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJanuary 30, 2018
January 1, 2018
2.5 years
April 25, 2015
January 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional brain network integrity: the strength of the correlation between fluctuating functional magnetic resonance imaging (fMRI) signal in different brain regions of the Default Mode Network (DMN) and the Executive Control Network (ECN) at rest
Resting state brain networks known to be vulnerable to decline with normal aging
Change from baseline functional network integrity at 12-weeks
Secondary Outcomes (4)
Motor learning rate
Change from baseline learning rate at 12-weeks
Explicit paired associates learning rate
Change from baseline learning rate at 12-weeks
Executive function composite measure
Change from baseline executive function performance at 12-weeks
Cardiovascular fitness measured as "Vo2 max" from a cycle ergometer test
Change from baseline fitness at 12-weeks
Study Arms (2)
Steady state moderate intensity cycling
EXPERIMENTALModerate intensity exercise training will be a 12-week supervised cycling program, with supervision directly from our research team. All participants will first receive a one-on-one orientation with an exercise training specialist that has been trained by Dr. Gary Pierce in monitoring an exercise program for healthy older adults. Training will start with a 5 minute-warm-up, 20 minutes moderate intensity cycling and 30 minutes passive cycling, and 5 minute cool-down per session, for 3 sessions/week. In each additional week, we will add 6 minutes of moderate intensity cycling per session, until the total time for moderate intensity is 50 minutes per session by the start of week 5 (with additional 5 minute warm-up and 5 minute cool-down).
Intermittent cycling
ACTIVE COMPARATORThe intermittent cycling group will come to the exercise lab for the same duration and frequency each week and complete primarily passive cycling such that a motor in the stationary bicycle moves the pedals for them. To maintain interest in this intervention, we will include short bouts of moderate intensity activity. The short bouts of moderate intensity cycling will be designed to be ineffective for substantially increasing cardiorespiratory fitness over the course of the intervention.
Interventions
The experimental group will complete a 3 month exercise program that includes working up to cycling at a moderate intensity for 50 minutes/session 3 times a week. The comparison group will complete a 3-month exercise program that includes intermittent cycling (alternating between passive and moderate intensity) for 50 minutes/session 3 times a week. Both groups will exercise in our laboratory at Spence Labs, and will be supervised by an exercise trainer that is trained in working with elderly and special populations.
Eligibility Criteria
You may qualify if:
- Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire, and corrected vision of 20/40.
- Because our older adult sample is over the age of 40, we will also require completion of a detailed health history questionnaire and further eligibility for the exercise intervention will be determined following approval from a physician that monitored electrocardiography (ECG) response during a maximal aerobic fitness test that is part of the second study visit described below.
You may not qualify if:
- Not between the ages of 60 and 80 years old
- Not fluent in English
- Score \< 26 (out of 30) on the Montreal Cognitive Assessment (MoCA)
- Inability to comply with experimental instructions
- Qualify as "high risk" for acute cardiovascular event by the published standards of the American College of Sports Medicine
- Left-handed
- Previous diagnosis of neurological, metabolic, or psychiatric condition, and no previous brain injury associated with loss of consciousness
- Inability to complete an MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HBC Lab
Iowa City, Iowa, 52245, United States
Related Publications (1)
Voss MW, Weng TB, Narayana-Kumanan K, Cole RC, Wharff C, Reist L, Dubose L, Sigurdsson G, Mills JA, Long JD, Magnotta VA, Pierce GL. Acute Exercise Effects Predict Training Change in Cognition and Connectivity. Med Sci Sports Exerc. 2020 Jan;52(1):131-140. doi: 10.1249/MSS.0000000000002115.
PMID: 31385912DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Voss, PhD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychological and Brain Sciences
Study Record Dates
First Submitted
April 25, 2015
First Posted
May 25, 2015
Study Start
July 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
January 30, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
In accord with NIH regulations, we will make the data and relevant documentation available to other investigators at their request upon acceptance of the main findings from the study for publication. Because the collected data are to remain anonymous, only a subject number will identify all data. To further protect the privacy and confidentiality of the data, data and documentation will be made available only under a data-sharing agreement that provides for restrictions for the transferring of data to others and a commitment that the data will be used for research purposes only and not for a profit-making enterprise.