The Environment's Impact on Thinking When Added to Leg Cycling in People With TBI: VITAL (VITAL)

The Effects of a Single Bout of Moderate Intensity Aerobic Exercise Combined With Different Environments on Executive Function and Processing Speed in Individuals With TBI

Aerobic exercise is a promising treatment modality for cognition in persons with TBI, but effects are consistently small. This study aims to investigate the effect of difference environments during moderate intensity cycling sessions on cognition.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Exercise Only; Behavioral: Exercise + Non-Immersive Virtual Reality; Behavioral: Exercise + Immersive Virtual Reality

Detailed Description

The proposed research study would be the first to investigate the acute effects of aerobic exercise with different environments relative to control and comparison conditions on several domains of cognition in people with TBI. This critical investigation will be a first step toward systematically identifying an optimal exercise training intervention for managing common cognitive consequences of TBI.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be at least 18 years of age and younger than 59 years of age
• Speak English as their primary language
• Have had a previous TBI at least one year prior\

Exclusion Criteria:

• Have contraindications to moderate or high intensity physical activity, based on the Physical Activity Readiness Questionnaire (PAR-Q)
• Have a history of psychiatric illness (ex: major depression, bipolar disorder, schizophrenia), neurological disorders beyond TBI (ex: stroke, seizure disorder), or substance abuse
• Currently use medications that might impact cognition (ex: steroids, benzodiazepines, neuroleptics)
• Be currently pregnant
• Have visual impairments not otherwise corrected by contact lenses (ex: stereo blindness, colorblindness)
• Have a high likelihood of motion sickness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Seated Rest; Behavioral: Seated Rest In the seated rest control condition, participants will sit on the bike for 30 minutes. Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart rate will be recorded every two minutes and perceived exertion will be reported every four minutes.
Active Comparator: Exercise Only; Behavioral: Exercise Only In the exercise-only condition, participants will complete a total of 30-minutes on the stationary bike. This will include a) 5-min warm-up at low resistance, b) 20 minutes of moderate-vigorous intensity cycling, and c) a 5-min cool-down at low resistance. Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart rate will be recorded every two minutes and perceived exertion will be reported every four minutes.	Behavioral: Exercise Only; Cycling in a lab environment
Experimental: Exercise + Non-Immersive Virtual Reality; Behavioral: Exercise + Non-Immersive Virtual Reality In the exercise with non-immersive Virtual Reality condition, participants will complete a total of 30-minutes on the stationary bike while watching a video on an iPad. The cycling session will be identical to that in the Exercise Only condition (5-min warm-up, 20 minutes of moderate-vigorous intensity cycling, and 5-min cool down). During cycling, a YouTube video called "360° VR Cycling Newport Back Bay Sunset [30 MIN - NO MUSIC])" will play on an iPad placed on the front of the bike. Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart rate will be recorded every two minutes and perceived exertion will be reported every four minutes.	Behavioral: Exercise + Non-Immersive Virtual Reality; Cycling with an environment simulated by non-immersive virtual reality
Experimental: Exercise + Immersive Virtual Reality; Behavioral: Exercise + Immersive Virtual Reality In the exercise with immersive virtual reality condition, participants will complete a total of 30-minutes on the stationary bike while wearing Oculus Quest 2 goggles. The bout of cycling will be identical to the prescription given in the exercise only condition (5-min warm-up, 20 minutes of moderate-vigorous intensity cycling, and 5-min cool down). During cycling, the Oculus YouTubeVR app will play a 360° version of the YouTube video called "360° VR Cycling Newport Back Bay Sunset [30 MIN - NO MUSIC])". Interaction with researchers will be kept at a minimum, similar to that in other sessions. Heart Rate will be recorded every two minutes and perceived exertion will be reported every four minutes.	Behavioral: Exercise + Immersive Virtual Reality; Cycling with an environment simulated by immersive virtual reality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on Walking While Talking Test (WWT)	The WWT measures multitasking by comparing performance on a single motor task to the motor performance during a simultaneous motor + cognitive dual task.	30 minutes (before and after the acute exercise intervention)
Change on N-Back Test (N-back)	The N-Back is a measure that requires participants to listen to a sequence of numbers and decide if the current number is the same as the one presented N trials ago.	30 minutes (before and after the acute exercise intervention)
Change on the Modified Flanker Test (MFT)	This task requires individuals to correctly respond to a target symbol amid other symbols, ignoring irrelevant information.	30 minutes (before and after the acute exercise intervention)

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): February 21, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Virtual Reality; Aerobic Exercise; Brain Injuries, Traumatic; Leg Cycling
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: R115220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No