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Clinical Trials/NCT03304327
NCT03304327CompletedNot Applicable

Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)

Duke University2 sites in 1 country16 target enrollmentStarted: September 27, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
2
Primary Endpoint
Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
15 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.

Time Frame: up to 7 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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