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Completed

NCT Number: NCT06263179

Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.

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Key information

Conditions

Concussion, Brain Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UBMD Orthopaedics and Sports Medicine

Williamsville, New York, 14221, United States

About this study

Participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. They will then perform a graded exertion test (the Buffalo Concussion Treadmill Test [BCTT]) at the clinic, this takes approximately 15 minutes. Participants will then be prescribed the individualized THRAE based on the results from the BCTT and will be sent home with a commercial heart rate monitor. Participants will perform exercises at home on their free time 4-5 days per week. Participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18-40
  • Received a concussion at work and are engaged with the workers compensation program
  • Within 3 weeks of concussive injury

Exclusion criteria

  • 3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI)
  • Moderate or severe TBI
  • Injury involving loss of consciousness for >30 minutes or post-traumatic amnesia > 24 hours
  • Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
  • History of more than 3 diagnosed concussions
  • Active substance abuse/dependence
  • Report of injury mechanism occurring due to physical assault
  • Unwillingness to perform intervention
  • Limited English proficiency.

Treatment and study plan

Target Heartrate Aerobic Exercise

Behavioral

Exercise program

Primary outcomes

  1. Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.

    Time frame: Up to 6 weeks

    Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed.

Secondary outcomes

  1. Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale

    Time frame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6

    The Post-Concussion Symptom Scale (PCSS) is a validated 22-item self-report symptom questionnaire. Scores range from 0-132 with greater scores indicating increased symptom burden.

  2. Change in Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, up to week 6

    The Patient Health Questionnaire-9 (PHQ-9) is used for rating the severity of depression among participants. Scores range from 0-27. Higher scores indicate increased severity of depression.

  3. Change in Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline, up to week 6

    The Generalized Anxiety Disorder-7 (GAD-7) is used to measure the severity of anxiety among participants. Scores range from 0-21. Higher scores indicate increased severity of anxiety.

  4. Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)

    Time frame: Baseline

    The Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) is used to measure probable PTSD among participants. Scores range from 0-5. Higher scores indicate increased probability of PTSD.

  5. Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)

    Time frame: Baseline, up to week 6

    The Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) is used to measure general healthcare-related quality of life, including global physical health and global mental health. Both global physical health and global mental health have raw scores ranging from 4-20. Higher scores reflect higher participant ratings for global physical and mental health. This measure will be used to assess change in global physical and mental health between the initial and final visits.

  6. Work Climate Questionnaire - 6-Item Version

    Time frame: Baseline

    The Work Climate Questionnaire - 6-Item Version is used for assessing participants' perceptions regarding the degree of autonomy supportiveness of their work managers or employers. Scores range of 6-42. Higher scores indicate a greater degree of perceived autonomy supportiveness.

  7. Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)

    Time frame: Baseline, up to week 6

    The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) is used to assess participant satisfaction or frustration with the psychological needs for autonomy, competence, and relatedness. The scale involves 6 subscales, including autonomy satisfaction, autonomy frustration, relatedness satisfaction, relatedness frustration, competence satisfaction, and competence frustration. Each subscale has scores ranging from 4-20. Higher scores indicate higher participant perceptions of the psychological need satisfaction or frustration reflected in the subscale. This measure will be used to assess change in psychological needs satisfaction and psychological needs frustration between the initial and final visits.

  8. Time to return to work measured in days

    Time frame: Up to week 6

    Time to return to work as measured by difference between date of injury and date the participant is medically cleared to return to work

Other outcomes

  1. Rate of adverse Events as assessed by questioning the participant

    Time frame: Up to week 6

    At each weekly follow-up meeting participants will be asked about any adverse events including injuries or other negative events.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 16, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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