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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Only
Exercise + Non-Immersive Virtual Reality
Exercise + Immersive Virtual Reality
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Brain Injuries, Traumatic, Aerobic Exercise, Leg Cycling, Virtual Reality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Experimental

Experimental

Arm Label

Seated Rest

Exercise Only

Exercise + Non-Immersive Virtual Reality

Exercise + Immersive Virtual Reality

Arm Description

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.

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 + 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 + 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.

Outcomes

Primary Outcome Measures

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.
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.
Change on the Modified Flanker Test (MFT)
This task requires individuals to correctly respond to a target symbol amid other symbols, ignoring irrelevant information.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2021
Last Updated
October 18, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04901286
Brief Title
The Environment's Impact on Thinking When Added to Leg Cycling in People With TBI: VITAL
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
February 21, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Brain Injuries, Traumatic, Aerobic Exercise, Leg Cycling, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
The PI will be blinded to the order of conditions for each participant.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seated Rest
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise Only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise + Non-Immersive Virtual Reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise + Immersive Virtual Reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Only
Intervention Description
Cycling in a lab environment
Intervention Type
Behavioral
Intervention Name(s)
Exercise + Non-Immersive Virtual Reality
Intervention Description
Cycling with an environment simulated by non-immersive virtual reality
Intervention Type
Behavioral
Intervention Name(s)
Exercise + Immersive Virtual Reality
Intervention Description
Cycling with an environment simulated by immersive virtual reality
Primary Outcome Measure Information:
Title
Change on Walking While Talking Test (WWT)
Description
The WWT measures multitasking by comparing performance on a single motor task to the motor performance during a simultaneous motor + cognitive dual task.
Time Frame
30 minutes (before and after the acute exercise intervention)
Title
Change on N-Back Test (N-back)
Description
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.
Time Frame
30 minutes (before and after the acute exercise intervention)
Title
Change on the Modified Flanker Test (MFT)
Description
This task requires individuals to correctly respond to a target symbol amid other symbols, ignoring irrelevant information.
Time Frame
30 minutes (before and after the acute exercise intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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