Environmental ExposureNCT03501953
Neurophysiological Mechanisms of Physical Activity Interventions in Unique Environments
A study testing Physical Activity in people with Environmental Exposure and Physical Activity, run by Northeastern University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure, Physical Activity
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2019to 1 May 2021
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- sedentary (1 or less exercise sessions per week)
- physically healthy
- normal or corrected-to-normal vision
- normal or corrected-to-normal hearing
Who cannot join
- currently treated for a neurological disorder
- currently treated for a physical health problem
About this study
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).
Read the 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.
- Conditions
- Environmental Exposure, Physical Activity
- Being tested
- Physical Activity
- Keywords
- Cognitive Change, Physical Activity, Environmental Exposure, Health Behavior
- Medical subject headings
- Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Six weeks of instructor-led physical activity sessions.
| Study group | Role | What they receive |
|---|---|---|
| Nature Exposure | Experimental | 6-week physical activity course in a natural environment Receives: Behavioral: Physical Activity |
| Urban Exposure | Active comparator | 6-week physical activity course in an urban environment Receives: Behavioral: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in spectral electroencephalography assessment at six weeks
Power at the midfrontal theta frequency
Measured: six weeks from start of intervention
Changes from baseline in event-related potentials at six weeks
Stimulus-locked P3 component associated with the flanker task
Measured: six weeks from start of intervention
Changes from baseline in cognitive assessment reaction time at six weeks
Reaction time on cognitive task
Measured: six weeks from start of intervention
Changed from baseline in cardio-respiratory fitness assessment at six weeks
VO2max performance
Measured: six weeks from start of intervention
Changes from baseline in cognitive assessment accuracy at six weeks
Accuracy score on cognitive task (0-100% score, higher accuracy is better)
Measured: six weeks from start of intervention
Secondary outcomes (2)
Accelerometry
number of steps and intensity of each session
Measured: 19 days
Heart rate
average and max heart rate of each session
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start15 Apr 2019 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion1 May 2021 (estimated)
Why it stopped: Study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- 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
- Model description
- Participants are randomly assigned to one of two intervention classes that either take place outdoors or indoors. Intervention conditions are identical in protocol and measurements taken, and differ only in location of intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Hillman, Principal investigator, Northeastern UniversityArthur Kramer, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501953
- Sponsor's protocol ID
- NortheasternU
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Mechanisms of Physical Activity Interventions in Unique Environments
- ClinicalTrials.gov ID
- NCT03501953
- Acronym / sponsor ID
- NortheasternU
- Conditions
- Environmental Exposure, Physical Activity
- Keywords
- Cognitive Change, Physical Activity, Environmental Exposure, Health Behavior
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 18 Apr 2018 (actual)
- 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.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two intervention classes that either take place outdoors or indoors. Intervention conditions are identical in protocol and measurements taken, and differ only in location of intervention.
| Arm | Type | Receives |
|---|---|---|
| Nature Exposure | Experimental | Behavioral: Physical Activity6-week physical activity course in a natural environment |
| Urban Exposure | Active comparator | Behavioral: Physical Activity6-week physical activity course in an urban environment |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- sedentary (1 or less exercise sessions per week)
- physically healthy
- normal or corrected-to-normal vision
- normal or corrected-to-normal hearing
Key exclusion criteria (2 listed)
- currently treated for a neurological disorder
- currently treated for a physical health problem
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 |
|---|---|---|
| Physical ActivitySix weeks of instructor-led physical activity sessions. | Behavioural | Nature Exposure, Urban Exposure |
Primary outcome
Change from baseline in spectral electroencephalography assessment at six weeks
Time frame: six weeks from start of intervention
Power at the midfrontal theta frequency
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
Changes from baseline in cognitive assessment reaction time at six weeks
Time frame: six weeks from start of intervention
Reaction time on cognitive task
Changed from baseline in cardio-respiratory fitness assessment at six weeks
Time frame: six weeks from start of intervention
VO2max performance
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)
2 secondary outcomes
Accelerometry
Time frame: 19 days
Heart rate
Time frame: 19 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Center for Cognitive and Brain HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Charles Hillman principal investigator
Northeastern University
Arthur Kramer principal investigator
Northeastern University
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Environmental Exposure and Physical Activity, run by Northeastern University.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in spectral electroencephalography assessment at six weeks (time frame: six weeks from start of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.