The Exercise and Concussion Health Study

Chapters Links
1. Inquiry Inquiry
2. Baseline Session Baseline Session
3. Interventions Interventions
4. Actigraphs Actigraphs
5. Endpoint Events Endpoint Session
6. Adverse Events Adverse Events
7. Data Analysis Data Analysis

1. Inquiry

Prior to Baseline- Inquiry/Interest etc.

  • Sources
  • RedCap form for interest
    • Links to it from the QR code on flyer or Facebook/Instagram ads
    • After reaching out via email to schedule call, label email under TECHS to notate it is present in RedCap
  • Calls/Emails
    • Directed to either google voice number or lab email
    • Add to RedCap regardless of eligibility
    • Email is labeled under TECHS once it is added to RedCap and PSL
  • The RedCap form should eliminate inclusion/exclusion on age and length of time since brain injury
  • If ineligible, send an email using template to tell them we appreciate their inquiry, but they are not eligible at this time.

Redcap:

Entering New Participant

  • Participant should begin with inquiry (whether on the phone, email, or online survey (where it’s completed automatically))
  • Change to techsID after prescreening is complete and participant is scheduled Pre-Screening Call- can be completed by trained uga
  • Attempt to confirm a scheduled call over email prior to calling, if possible, if not simply call during appropriate business hours
  • Use RedCap form for Prescreening and go through the criteria as questions
  • If unsure, leave a comment or note on the redcap form
  • If they flag one of the immediate inclusion/exclusion factors you do not have to continue the call (not cleared for exercise, age, time since injury or location (if they can travel to Boston for the baseline without any financial help from us but live elsewhere, that can work))
    • If you’re unsure, finish the call and consult Emma afterwards.
  • If they don't have a diagnosis, you can continue the call and ask if they are willing to speak with a clinician to confirm diagnosis. If there is any uncertainty on diagnosis, wait to schedule until Lexie MD verified.
  • Complete the MRI Subject Screening Form to ensure they can safely have an MRI (Either done on the computer or a hard copy can be printed and scanned in)
  • This needs to be de-identified and sent to Fred with scheduled MRI appointment.
  • Once scheduled, add to basecamp, scheduling and info sheet, and techs master doc
  • Once scheduled, send confirmation email attached with briefing form, parking information, and consent form. Ask them to send confirmation of concussion diagnosis as well (unless we are waiting for lexie MD)

Potential “Holding Patterns” That Can Occur In Between The PS Call & Scheduling Baseline

  • Awaiting Lexie MD confirmation on diagnosis
  • Confirm MRI safety with Fred/Valur or participant
  • Participant needs to confirm exercise safety with PCP or cardiologist
  • Participant needs to arrange travel (emphasizing we do not cover this, but they do voluntarily)

Scheduling Baseline Session

  • Should be done with or by Emma
  • Scheduled primarily due to MRI availability (accessed through Emma/Lexie outlook calendar) as that’s the most restrictive
  • Secondly confirm Emma, Mark, and one of the undergrads availabilities
  • If necessary to be in 2 sessions, try to have as close together as possible
  • Remind of session 24-48 hours prior via text message

Preparing for Baseline

  • Ensure proper rooms are scheduled for Baseline
  • Neuropysch Room for cognitive/questionnaires
    • Have this reserved for after EEG as well for the tech set-up
  • EEG in EEG Room
  • VO2 room for fitness and balance test
  • Print documents in Print for Baseline
  • Informed Consent (Print 2)
  • W9
  • TMT A/B paper copy
  • Letter/Cat Handout
  • Charge Surface Tablet
  • Initialize actigraph
  • Prepare sleep log and mailing envelop

2. Baseline Session

  • Consent & W9
  • Go through consent form and provide them a copy with the person administering the consent signing (the important thing is to have the copy we keep having both signatures and they one they take home having our signature) o Have them complete the W9 at this time as well
  • Make sure we have their emergency contact. It should be in prescreening and on techs master doc

MRI

MRI Protocol

Questionnaires/Cog Tasks

  • Health History and Demographics
  • Hopkins Verbal Learning Test**
    • Done at beginning and followed 20 minutes later with delayed recall/recognition
    • 3 Learning Trials and recall and recognition
    • be cautious of delayed recognition scoring
  • Letter and Category Fluency
  • OSU
  • TMT
  • International Physical Activity
  • Mediterranean Diet Adherence
  • Pittsburgh Sleep Quality Index
  • Promis
  • Hopkins Verbal Learning Test
    • Delayed Recall & Delayed Recognition

EEG

EEG Protocol

BESS

BESS Protocol

Astrand Rhyming VO2 sub max (ALWAYS LAST)

Astrand Rhyming VO2 sub max Make sure you record hyperate and save to participant files after

End of Baseline

At end of the session make sure participant goes home with HR monitor and actigraph (foam pad if balance) and briefing form Update the equipment list At the end of the Baseline visit, the participant is randomized to aerobic or balance.

3. Interventions

Protocols

3xweek for 30 minutes for 12 weeks.

Redcap

Redcap

Safety Observer

Safety Observer

Session Leader

Session Leader Notes

Aerobic Protocol

Aerobic Protocol

Balance Protocol

Balance Protocol

Hyperate

Hyperate

4. Actigraphs

Participant gets actigraph at baseline, at 6 weeks, and at 12 weeks. Send via mail start of week 5 and start of week 11. Actigraph Document

5. Endpoint Session

Scheduling endpoint

  • At week 10, text or ask participant during a session to schedule endpoint.
  • 1 day before endpoint text participant to remind them of session and to remind them to bring back equipment (HR monitor, actigraph, foam pad if balance)

Questionnaires/Cog Tasks

  • Health History and Demographics
  • Hopkins Verbal Learning Test** Done at beginning and followed 20 minutes later with delayed recall/recognition
  • 3 Learning Trials and recall and recongition
  • Letter and Category Fluency
  • TMT
  • Digital- C/D
  • Paper- A/B
  • Pittsburgh Sleep Quality Index
  • Hopkins Verbal Learning Test
  • Delayed Recall & Delayed Recognition be cautious of delayed recognition scoring

MRI

MRI Protocol

EEG

EEG Protocol

BESS

BESS Protocol

Astrand Rhyming VO2 sub max (ALWAYS LAST)

Astrand Rhyming VO2 sub max - Make sure you record hyperate and save to participant files after - Sign invoice - Use dpay to pay participant after session

6. Adverse Events

Fill out adverse events form on redcap. - Serious adverse events are reported to IRB within 48 hours. It includes death, life threatening, long hospitlization or damage, general abnormality or birth defecrt. - Anything else should be reported to IRB within 10 days.

7. Data Analysis

Data analysis code can be found here. You can download the data from redcap to a csv.