Neurophysiological Mechanisms of Physical Activity Interventions in Unique Environments

NCT03501953 | Withdrawn DMC

• 1 other identifier: NortheasternU
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 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).

Conditions

Environmental Exposure; Physical Activity

Keywords

Cognitive Change; Physical Activity; Environmental Exposure; Health Behavior

Outcome Measures

Primary Outcomes (5)

• Change from baseline in spectral electroencephalography assessment at six weeks

  Power at the midfrontal theta frequency

  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

  six weeks from start of intervention

• Changes from baseline in cognitive assessment reaction time at six weeks

  Reaction time on cognitive task

  six weeks from start of intervention

• Changed from baseline in cardio-respiratory fitness assessment at six weeks

  VO2max performance

  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)

  six weeks from start of intervention

Secondary Outcomes (2)

• Accelerometry

  19 days

• Heart rate

  19 days

Study Arms (2)

Nature Exposure

EXPERIMENTAL

6-week physical activity course in a natural environment

Behavioral: Physical Activity

Urban Exposure

ACTIVE COMPARATOR

6-week physical activity course in an urban environment

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

Six weeks of instructor-led physical activity sessions.

Nature Exposure; Urban Exposure

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• sedentary (1 or less exercise sessions per week)
• physically healthy
• normal or corrected-to-normal vision
• normal or corrected-to-normal hearing

You may not qualify if:

• currently treated for a neurological disorder
• currently treated for a physical health problem

Sponsors & Collaborators

• Northeastern University: lead

Related Links

• Center for Cognitive and Brain Health

MeSH Terms

Conditions

Motor Activity; Health Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Charles Hillman

  Northeastern University

  PRINCIPAL INVESTIGATOR

• Arthur Kramer

  Northeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 18, 2018
• Study Start: April 15, 2019
• Primary Completion: October 31, 2019
• Study Completion: May 1, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.