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

Traumatic Brain Injury Clinical Trial

— VITAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901286
• Other study ID #: R115220
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: October 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 30, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Behavioral:
• Exercise Only
Cycling in a lab environment
• Exercise + Non-Immersive Virtual Reality
Cycling with an environment simulated by non-immersive virtual reality
• Exercise + Immersive Virtual Reality
Cycling with an environment simulated by immersive virtual reality

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)