- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501953
Neurophysiological Mechanisms of Physical Activity Interventions in Unique Environments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research has yet to determine how regular physical activity in different environments influences physical and cognitive performance. Studies show exposure to natural environments can improve cognitive performance, increase creative thinking, and decrease stress-related responses. According to the theory of attention restoration, exposure to natural environments restores attentional resources because nature contains specific qualities that allow for directed attention to replenish and endorses health-related behaviors such as walking, running, and biking. Nature exposure is hypothesized to decrease activation of neural networks involved in cognitive control, therefore allowing for restoration of resources to occur. Activation of the cognitive control network is reflected through increased power of theta frequency (4-8 Hz) at the midfrontal regions (measured using electroencephalography; EEG), which reflects cognitive fatigue during rest. Previous research shows spending time in nature decreases midfrontal theta power, therefore reducing rumination and cognitive fatigue. Likewise, event-related potentials, such as higher P3 amplitude and shorter P3 latency during tasks, indicate better attentional allocation and processing speed, indicating better cognitive processing. These neurophysiological measurements are indicative of cognitive restoration and can determine changes in cognitive functioning over time.
The investigators propose to collect measurements of electroencephalography (spectral EEG, task-evoked event-related potentials), behavioral cognitive assessments (cognitive control, working memory performance), and health factors (VO2max) using a 2 (nature or urban physical activity intervention) x 2 (baseline and post-intervention sessions) design to determine changes in cognitive functioning across time. As part of an ongoing investigation in the cognitive and physical influence of intervention strategies, physical activity interventions will take place for a 6-week period, and participants will be recruited across three intervals of testing. Trained fitness instructors will lead participants in regularly scheduled 45-minute aerobic-based physical activity sessions three times a week. Each session will involve a combination of walking and running that progressively increases the duration of intensity throughout the 6-week period, starting at 20-minutes of moderate-to-vigorous training during the first week, and increasing duration by 5-minute intervals. Intervention groups will differ based on the location of the intervention. The nature-based intervention sessions will occur outdoors in a local public park in the Boston area. The urban-based intervention sessions will occur indoors in the Center for Cognitive & Brain Health intervention activity rooms.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- sedentary (1 or less exercise sessions per week)
- physically healthy
- normal or corrected-to-normal vision
- normal or corrected-to-normal hearing
Exclusion Criteria:
- currently treated for a neurological disorder
- currently treated for a physical health problem
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nature Exposure
6-week physical activity course in a natural environment
|
Six weeks of instructor-led physical activity sessions.
|
|
Active Comparator: Urban Exposure
6-week physical activity course in an urban environment
|
Six weeks of instructor-led physical activity sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in spectral electroencephalography assessment at six weeks
Time Frame: six weeks from start of intervention
|
Power at the midfrontal theta frequency
|
six weeks from start of intervention
|
|
Changes from baseline in event-related potentials at six weeks
Time Frame: six weeks from start of intervention
|
Stimulus-locked P3 component associated with the flanker task
|
six weeks from start of intervention
|
|
Changes from baseline in cognitive assessment reaction time at six weeks
Time Frame: six weeks from start of intervention
|
Reaction time on cognitive task
|
six weeks from start of intervention
|
|
Changed from baseline in cardio-respiratory fitness assessment at six weeks
Time Frame: six weeks from start of intervention
|
VO2max performance
|
six weeks from start of intervention
|
|
Changes from baseline in cognitive assessment accuracy at six weeks
Time Frame: six weeks from start of intervention
|
Accuracy score on cognitive task (0-100% score, higher accuracy is better)
|
six weeks from start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accelerometry
Time Frame: 19 days
|
number of steps and intensity of each session
|
19 days
|
|
Heart rate
Time Frame: 19 days
|
average and max heart rate of each session
|
19 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles Hillman, Northeastern University
- Principal Investigator: Arthur Kramer, Northeastern University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NortheasternU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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