Aerobic Exercise After Traumatic Brain Injury

Part of paid clinical trials in Bakersfield, California.

Sponsor
Centre for Neuro Skills
Study ID
NCT05786729
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Aerobic Exercise (AER) — OTHER
    Aerobic exercise will be performed by utilizing aerobic exercise equipment 3 times per week.
  • Rehabilitation — OTHER
    Rehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills.

Study Details

The purpose of this study is to examine the effects of individualized aerobic exercise regimen on recovery after traumatic brain injury (TBI).Investigators will determine if exercise facilitates recovery by facilitating neuroplasticity and decreasing neuroinflammation.

Key Dates

Start date
Jan 18, 2022
Status verified
Mar 2023
Primary completion
Jan 18, 2027
Completion
Jan 18, 2028

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Aerobic Exercise (AER)
    Consented participants will be randomly assigned to aerobic exercise regimen (AER) + Standard Rehabilitation(R+AER) or Standard Rehabilitation only (R) group. In order to determine the necessary time window for AER exercise treatment, TBI subjects will partake in supervised AER sessions for a period of 12 weeks. After a baseline evaluations follow-ups will take place at take place at weeks 4, 8 and 12. Thus each participants will be evaluated 4 times.
  • Active Comparator: Rehabilitation (R)
    Participants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program. These participants will receive standard rehabilitation. Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 12 weeks. Activity levels will be monitored.
  • No Intervention: Control (C)
    Healthy volunteers' responsiveness to exercise will be compared to TBI responsiveness.

Primary Outcome Measure

Aerobic Exercise Induced Changes in Cardio Pulmonary Exercise (CPET) at baseline [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Centre for Neuro SkillsBakersfieldCalifornia93313-

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Centre for Neuro Skills· Bakersfield, CA

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