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

NCT ID: NCT04901286

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2023-03-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Exercise Only

Intervention Type: BEHAVIORAL

Cycling in a lab environment

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.

Group Type: EXPERIMENTAL

Exercise + Non-Immersive Virtual Reality

Intervention Type: BEHAVIORAL

Cycling with an environment simulated by non-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.

Group Type: EXPERIMENTAL

Exercise + Immersive Virtual Reality

Intervention Type: BEHAVIORAL

Cycling with an environment simulated by immersive virtual reality

Interventions

Exercise Only

Cycling in a lab environment

Intervention Type: BEHAVIORAL

Exercise + Non-Immersive Virtual Reality

Cycling with an environment simulated by non-immersive virtual reality

Intervention Type: BEHAVIORAL

Exercise + Immersive Virtual Reality

Cycling with an environment simulated by immersive virtual reality

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Carly Wender

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

R115220

Identifier Type: -

Identifier Source: org_study_id