Neurophysiological Mechanisms of Physical Activity Interventions in Unique Environments

August 19, 2019 updated by: Northeastern University
This randomized intervention is designed to compare the influence of physical activity in natural and urban environments on cognitive and physical health. Half of the participants will participate in a six-week physical activity class based in a natural environment, and half of the participants will participate in a six-week physical activity class based in an indoor environment. The investigators hypothesize the nature-based intervention will produce lower cognitive fatigue (measured using neurophysiological measurements), better cognitive performance (measured using cognitive assessments), and increased physical fitness (measuring using fitness testing).

Study Overview

Status

Withdrawn

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

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charles Hillman, Northeastern University
  • Principal Investigator: Arthur Kramer, Northeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2019

Primary Completion (Anticipated)

October 31, 2019

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

April 3, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

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)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be available within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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