Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

April 4, 2024 updated by: Jacob I. McPherson, State University of New York at Buffalo
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Target Heartrate Aerobic Exercise (THRAE)
Participants will be asked to complete the Buffalo Concussion Treadmill Test (BCTT), a safe graded exercise test that is used to identify concussion-related exertion intolerance. Participants will wear a heart rate (HR) monitor for the collection of continuous HR data. The test is stopped when a participant's symptoms increase subjectively by an intensity of 3 points or more from the pre-exercise value on a scale from 0-10, or they report being physically exhausted. Their HR at the time of test termination constitutes the HR threshold (HRt). An individualized THRAE program will be prescribed based on 80% of the HRt on the BCTT. Participants will be given a Polar HR monitor to wear while performing their THRAE prescription, which will be performed at home for 20 minutes, 4-5 days per week, for 6 weeks or until medically cleared from their concussion.
Behavioral: Target Heartrate Aerobic Exercise
Exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 1, week 2, week 3, week 4, week 5, week 6
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.
Baseline, up to week 6
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.
Baseline, up to week 6
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.
Baseline
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.
Baseline, up to week 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.
Baseline
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.
Baseline, up to week 6
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
Up to week 6

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Jacob McPherson, SUNY Buffalo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 14, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007706
  • UL1TR001412 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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