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

NCT04901286 | Completed

• 1 other identifier: R115220
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Brain Injuries, Traumatic; Aerobic Exercise; Leg Cycling; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (4)

Seated Rest

NO INTERVENTION

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.

Exercise Only

ACTIVE COMPARATOR

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

Exercise + Non-Immersive Virtual Reality

EXPERIMENTAL

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

Exercise + Immersive Virtual Reality

EXPERIMENTAL

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

Interventions

Exercise Only BEHAVIORAL

Cycling in a lab environment

Exercise Only

Exercise + Non-Immersive Virtual Reality BEHAVIORAL

Cycling with an environment simulated by non-immersive virtual reality

Exercise + Non-Immersive Virtual Reality

Exercise + Immersive Virtual Reality BEHAVIORAL

Cycling with an environment simulated by immersive virtual reality

Exercise + Immersive Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\\

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The PI will be blinded to the order of conditions for each participant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 25, 2021
• Study Start: August 19, 2021
• Primary Completion: February 21, 2023
• Study Completion: March 30, 2023
• Last Updated: September 2, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)