Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)

Not Applicable

Completed

• Conditions: Concussion
• Interventions: Behavioral: Mindfulness and Yoga Training

• Registration Number: NCT03304327
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in the post-concussion period.

Detailed Description

Athletes and patients aged 15 - 60 will receive standard sports concussion evaluations at the Duke Sports Science Institute (SSI) and will learn about the study by the primary clinicians evaluating sports concussion at the SSI. Subjects will receive yoga training either at their home or at the Center for Living Campus at Duke. Subjects will complete their yoga assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects will complete the symptom checklist and mail all checklists to the study team in a stamped envelope. We expect to enroll 20 subjects.

If a subject has significant worsening of their symptoms and wishes to discontinue the study, they are requested to contact the study PI, Joel Morgenlander, MD. At that time, Dr. Morgenlander will document the specific reasons for discontinuation of the protocol. All follow-up care for their concussion will be through the provider they are already seeing for concussion. There is no significant risk to the athlete for participation except possible transient increase in their concussion symptoms. Benefits include possible hastening of recovery from their concussive symptoms and receiving training in mindfulness and yoga from a certified yoga instructor.

Study Timeline

• Study Start: 2017-09-27
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-09
• Primary Completion: 2019-09-23
• Study Completion: 2019-09-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Injury sustained within 30 days of enrollment
• Being seen for concussion at the Sports Science Institute (SSI) at Duke University Medical Center
• living in a 30 mile radius of the SSI
• SCAT5 (Sport Concussion Assessment Tool 5) modified symptom checklist score of greater than 12

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfullness and Yoga	Mindfulness and Yoga Training	Subjects will receive yoga training either at their home or at the Center for Living Campus at Duke. Subjects will complete their yoga assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects will complete the symptom checklist and mail all checklists to the study team

Primary Outcome Measures

Name	Time	Method
Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.	up to 7 days

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States