Recruiting
Phase 1

Exercise & Rehabilitation

Sponsor:

Centre for Neuro Skills

Code:

NCT03407924

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Aerobic Exercise (AER)

Rehabilitation

Study Details

Brief summary:

The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery.

Conditions

Traumatic Brain Injury

Study ID

NCT03407924

Start date

Jun, 2016

Status verified date

Jan, 2018

Completion date

Mar, 2022

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Clinical diagnosis of TBI (for R+AER and R groups).
  • Fluency in English or Spanish.
  • Able to walk with or without a device.

Exclusion Criteria:

  • Orthopedic or cardiac conditions that prevent from exercising.
  • Current diagnosis of neurological and/or psychiatric diseases.

Unable to be in the Los Angeles CA metropolitan area for the duration of the study

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention aerobic exercise (AER)

Participants with traumatic brain injury (TBI) that are enrolled in a comprehensive rehabilitation program (R) will be engaged in an aerobic exercise program (AER). These participants will also receive standard rehabilitation which includes exercise within the physical therapy session. Given that the duration of the rehabilitative program is variable the period of AER training will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored.

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 30 weeks. Activity levels will be monitored.

no intervention: control (C)

Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.

Interventions

Aerobic Exercise (AER)

Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week. Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down. Participants will wear a safety harness.

Rehabilitation

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.

Primary outcome measure

  • Aerobic Exercise Induced Changes in Inflammatory responses to exercise [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
  • Aerobic Exercise Induced Changes in Cognitive Function [ Time Frame: 5 years ]
  • Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]
  • Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise [ Time Frame: 4 to 30 weeks depending on the duration of rehabilitation coverage. ]

Central Contacts and Locations

Central contacts

Grace S Griesbach, PhD

(818)783-3800researchcentre@neuroskills.com

Lisa Kreber, PhD

(661)873-6513researchcentre@neuroskills.com

Locations

Centre for Neuro Skills

Recruiting

Encino, California, United States, 91436

Contacts

Grace Griesbach, PhD

818-783-3800researchcentre@neuroskills.com

Charan Singh, MS

(661)872-3408csingh@neuroskills.com

More Information

Sponsor

Centre for Neuro Skills

Last update posted

Jan 30, 2018

Last verified

Jan, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre for Neuro Skills on 2018-01-30.