Sedentary LifestyleBIKENCT02453178
Effects of a Bicycling Intervention on Cognitive Skills and Cardiovascular Health
A study testing Cycling in people with Sedentary Lifestyle, run by University of Iowa at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Given the rising proportion of older adults worldwide and the progressive decline in brain function with advancing age, there is a pressing need to develop novel interventions that protect the aging brain. The predominant approach for implementing exercise training to improve brain function is to increase cardiovascular fitness. However, there is mixed empirical support for the effectiveness of this approach. Further, there are also acute effects of exercise within one hour of the cessation of a single exercise session. These effects occur before adaptations related to fitness could occur and animal studies have shown they occur in the same brain regions that benefit from longer-term exercise training. Therefore, the investigators propose the acute paradigm is a tool to probe this early, direct response from exercise in order to determine how best to maximize the long-term benefit of exercise training on the aging brain. This presents a critical need to determine the mechanistic relation between acute and long-term effects of exercise on the aging brain. Our long-term goal is to determine how exercise protects the brain from the adverse effects of aging. In turn, our specific objective in this R21 proposal is to support or refute the concept that a single session of exercise produces acute increases in functional synchrony of clinically relevant brain networks that are related to accrued exercise-training effects in the same brain systems. Our central hypothesis is that the effects of moderate intensity exercise will increase the functional synchrony of the hippocampus with the Default Mode Network, and the Prefrontal Cortex with the Fronto-Executive Network, in the same fashion as a 12-week moderate intensity exercise training program. This hypothesis is based on data showing acute effects of exercise on factors related to neuronal plasticity and excitability in the same brain regions that show long-term effects of exercise in animals. The contribution of the proposed research is significant because it will determine the extent to which the acute exercise paradigm can provide insight into how regular exercise protects the brain from adverse effects of aging. The proposed research is innovative because for the first time the investigators will examine the overlapping neural systems and outcomes associated with acute and chronic exercise in the same individuals. Overall, success in this project will enable future research to study how varying exercise parameters such as mode or intensity affect exercise-induced change in brain function and the timecourse of these effects, as well as the neurobiological mechanisms associated with the direct effects of exercise on the aging brain.
- Conditions
- Sedentary Lifestyle
- Being tested
- Cycling
- Keywords
- physical activity, aging, cognition, brain, exercise
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclingBehavioural
Also called Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Steady state moderate intensity cycling | Experimental | Moderate 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). Receives: Behavioral: Cycling |
| Intermittent cycling | Active comparator | The 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. Receives: Behavioral: Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline functional network integrity at 12-weeks
Secondary outcomes (4)
Motor learning rate
Learning rate parameter expressing rate of reaction time speeding in an alternating serial reaction time task (ASRTT)
Measured: Change from baseline learning rate at 12-weeks
Explicit paired associates learning rate
Learning rate parameter expressing rate of improvement in accuracy in a paired associates learning task
Measured: Change from baseline learning rate at 12-weeks
Executive function composite measure
Composite score from performance (speed and accuracy) on four executive function tasks, including Trails A and B, Go/No-Go dual task, a modified flanker task, and a non-verbal working memory n-back task
Measured: Change from baseline executive function performance at 12-weeks
Cardiovascular fitness measured as "Vo2 max" from a cycle ergometer test
The ability of the heart and lungs to supply oxygen to working muscle tissues and the ability of the muscles to use oxygen to produce energy for movement
Measured: Change from baseline fitness at 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle W. Voss, University of Iowa
- Investigators
- Michelle Voss, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453178
- Sponsor's protocol ID
- 201405837
- Acronym
- BIKE
- Status last verified
- Jan 2018
- First submitted
- 25 Apr 2015
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31385912
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Bicycling Intervention on Cognitive Skills and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT02453178
- Acronym / sponsor ID
- BIKE / 201405837
- Conditions
- Sedentary Lifestyle
- Keywords
- physical activity, aging, cognition, brain, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Given the rising proportion of older adults worldwide and the progressive decline in brain function with advancing age, there is a pressing need to develop novel interventions that protect the aging brain. The predominant approach for implementing exercise training to improve brain function is to increase cardiovascular fitness. However, there is mixed empirical support for the effectiveness of this approach. Further, there are also acute effects of exercise within one hour of the cessation of a single exercise session. These effects occur before adaptations related to fitness could occur and animal studies have shown they occur in the same brain regions that benefit from longer-term exercise training. Therefore, the investigators propose the acute paradigm is a tool to probe this early, direct response from exercise in order to determine how best to maximize the long-term benefit of exercise training on the aging brain. This presents a critical need to determine the mechanistic relation between acute and long-term effects of exercise on the aging brain. Our long-term goal is to determine how exercise protects the brain from the adverse effects of aging. In turn, our specific objective in this R21 proposal is to support or refute the concept that a single session of exercise produces acute increases in functional synchrony of clinically relevant brain networks that are related to accrued exercise-training effects in the same brain systems. Our central hypothesis is that the effects of moderate intensity exercise will increase the functional synchrony of the hippocampus with the Default Mode Network, and the Prefrontal Cortex with the Fronto-Executive Network, in the same fashion as a 12-week moderate intensity exercise training program. This hypothesis is based on data showing acute effects of exercise on factors related to neuronal plasticity and excitability in the same brain regions that show long-term effects of exercise in animals. The contribution of the proposed research is significant because it will determine the extent to which the acute exercise paradigm can provide insight into how regular exercise protects the brain from adverse effects of aging. The proposed research is innovative because for the first time the investigators will examine the overlapping neural systems and outcomes associated with acute and chronic exercise in the same individuals. Overall, success in this project will enable future research to study how varying exercise parameters such as mode or intensity affect exercise-induced change in brain function and the timecourse of these effects, as well as the neurobiological mechanisms associated with the direct effects of exercise on the aging brain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steady state moderate intensity cycling | Experimental | Behavioral: CyclingModerate 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 comparator | Behavioral: CyclingThe 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclingAlso: ExerciseThe 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. | Behavioural | Intermittent cycling, Steady state moderate intensity cycling |
Primary outcome
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
Time frame: Change from baseline functional network integrity at 12-weeks
Resting state brain networks known to be vulnerable to decline with normal aging
4 secondary outcomes
Motor learning rate
Time frame: Change from baseline learning rate at 12-weeks
Explicit paired associates learning rate
Time frame: Change from baseline learning rate at 12-weeks
Executive function composite measure
Time frame: Change from baseline executive function performance at 12-weeks
Cardiovascular fitness measured as "Vo2 max" from a cycle ergometer test
Time frame: Change from baseline fitness at 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 31385912Voss 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Voss, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling in people with Sedentary Lifestyle, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Change from baseline functional network integrity at 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.