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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Exercise Only; Behavioral: Exercise + Non-Immersive Virtual Reality; Behavioral: Exercise + Immersive Virtual Reality

• Registration Number: NCT04901286
• Lead Sponsor: Kessler Foundation

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.

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 Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-25
• Study Start: 2021-08-19
• Primary Completion: 2023-02-21
• Study Completion: 2023-03-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise Only	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.
Exercise + Non-Immersive Virtual Reality	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.
Exercise + Immersive Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
Change on N-Back Test (N-back)	30 minutes (before and after the acute exercise intervention)	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.
Change on the Modified Flanker Test (MFT)	30 minutes (before and after the acute exercise intervention)	This task requires individuals to correctly respond to a target symbol amid other symbols, ignoring irrelevant information.
Change on Walking While Talking Test (WWT)	30 minutes (before and after the acute exercise intervention)	The WWT measures multitasking by comparing performance on a single motor task to the motor performance during a simultaneous motor + cognitive dual task.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States