## Protocol Section
### Identification Module
**NCT ID:** NCT06263179

**Brief Title:** Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

**Official Title:** Feasibility of Aerobic Exercise for Recovery From Work-related Concussion

#### Organization Study ID Info
**ID:** STUDY00007706
#### Organization
**Class:** OTHER
**Full Name:** State University of New York at Buffalo
#### Secondary ID Infos
**ID:** UL1TR001412
**Link:** https://reporter.nih.gov/quickSearch/UL1TR001412
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-08

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-04

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-14

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-02-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-29
**Study First Submit QC Date:** 2024-02-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Center for Advancing Translational Sciences (NCATS)

#### Lead Sponsor

**Class:** OTHER

**Name:** State University of New York at Buffalo

#### Responsible Party

**Investigator Affiliation:** State University of New York at Buffalo

**Investigator Full Name:** Jacob I. McPherson

**Investigator Title:** Clinical Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**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).

### Conditions Module

**Conditions:**

- Concussion, Brain

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Target Heartrate Aerobic Exercise

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Target Heartrate Aerobic Exercise

**Label:** Target Heartrate Aerobic Exercise (THRAE)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Target Heartrate Aerobic Exercise (THRAE)

**Description:** Exercise program

**Name:** Target Heartrate Aerobic Exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

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

**Measure:** Rate of adverse Events as assessed by questioning the participant

**Time Frame:** Up to week 6

#### Primary Outcomes

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

**Measure:** 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

#### Secondary Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** Change in Patient Health Questionnaire-9 (PHQ-9)

**Time Frame:** Baseline, up to week 6

**Description:** 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.

**Measure:** Change in Generalized Anxiety Disorder-7 (GAD-7)

**Time Frame:** Baseline, up to week 6

**Description:** 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.

**Measure:** Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)

**Time Frame:** Baseline

**Description:** 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.

**Measure:** Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)

**Time Frame:** Baseline, up to week 6

**Description:** 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.

**Measure:** Work Climate Questionnaire - 6-Item Version

**Time Frame:** Baseline

**Description:** 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.

**Measure:** Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)

**Time Frame:** Baseline, up to week 6

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

**Measure:** Time to return to work measured in days

**Time Frame:** Up to week 6

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jim6@buffalo.edu

**Name:** Jacob McPherson, PhD

**Phone:** 7168296734

**Role:** CONTACT

**Contact 2:**

**Email:** cjstavis@buffalo.edu

**Name:** Christopher Stavisky, PhD

**Phone:** (716)829-6805

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** SUNY Buffalo

**Name:** Jacob McPherson

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Sharma B, Nowrouzi-Kia B, Mollayeva T, Kontos P, Grigorovich A, Liss G, Gibson B, Mantis S, Lewko J, Colantonio A. Work-related traumatic brain injury: A brief report on workers perspective on job and health and safety training, supervision, and injury preventability. Work. 2019;62(2):319-325. doi: 10.3233/WOR-192866.

**PMID:** 30829642

**Citation:** Leddy JJ, Haider MN, Ellis MJ, Mannix R, Darling SR, Freitas MS, Suffoletto HN, Leiter J, Cordingley DM, Willer B. Early Subthreshold Aerobic Exercise for Sport-Related Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2019 Apr 1;173(4):319-325. doi: 10.1001/jamapediatrics.2018.4397.

**PMID:** 30715132

**Citation:** Leddy JJ, Master CL, Mannix R, Wiebe DJ, Grady MF, Meehan WP, Storey EP, Vernau BT, Brown NJ, Hunt D, Mohammed F, Mallon A, Rownd K, Arbogast KB, Cunningham A, Haider MN, Mayer AR, Willer BS. Early targeted heart rate aerobic exercise versus placebo stretching for sport-related concussion in adolescents: a randomised controlled trial. Lancet Child Adolesc Health. 2021 Nov;5(11):792-799. doi: 10.1016/S2352-4642(21)00267-4. Epub 2021 Oct 1.

**PMID:** 34600629

**Citation:** de Koning ME, Scheenen ME, van der Horn HJ, Timmerman ME, Hageman G, Roks G, Spikman JM, van der Naalt J. Prediction of work resumption and sustainability up to 1 year after mild traumatic brain injury. Neurology. 2017 Oct 31;89(18):1908-1914. doi: 10.1212/WNL.0000000000004604. Epub 2017 Oct 6.

**PMID:** 28986414

**Citation:** Kristman VL, Cote P, Van Eerd D, Vidmar M, Rezai M, Hogg-Johnson S, Wennberg RA, Cassidy JD. Prevalence of lost-time claims for mild traumatic brain injury in the working population: improving estimates using workers compensation databases. Brain Inj. 2008 Jan;22(1):51-9. doi: 10.1080/02699050701849991.

**PMID:** 18183509

**Citation:** Smith CK, Wuellner S, Marcum J. Racial and ethnic disparities in workers' compensation claims rates. PLoS One. 2023 Jan 17;18(1):e0280307. doi: 10.1371/journal.pone.0280307. eCollection 2023.

**PMID:** 36649295

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-01-26

- Filename: ICF_000.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 252809

- Type Abbrev: ICF

- Upload Date: 2024-01-29T12:18

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000070642

- Term: Brain Injuries, Traumatic

- ID: D000001930

- Term: Brain Injuries

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000016489

- Term: Head Injuries, Closed

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000014949

- Term: Wounds, Nonpenetrating

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5201

- Name: Brain Concussion

- Relevance: HIGH

- As Found: Concussion, Brain

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M18892

- Name: Head Injuries, Closed

- Relevance: LOW

- As Found: Unknown

- ID: M17687

- Name: Wounds, Nonpenetrating

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001924

- Term: Brain Concussion

### Misc Info Module

- Version Holder: 2024-05-24
