Mindfulness and Yoga Training for Athletes With Concussion (MYTAC) ((MYTAC))

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

Study Overview

• Status: Completed
• Conditions: Concussion
• Intervention / Treatment: Behavioral: Mindfulness and Yoga Training

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfullness and Yoga; 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

Behavioral: Mindfulness and Yoga Training; Centering and Breathing- Practice begins by turning attention to the breath to help participants make the transition from the busy, doing, outward focus of daily life into the mindful, balanced, internal focus central to yoga practice. Practices:Breath awareness, the relaxed abdominal breath. Posture Practice-Warm up with the range-of-motion sequence to take the major joints of the body through their full range of motion.This is done lying down with the head on the floor; the head can be supported by a small, folded towel if desired. Practices: Knee-to-chest sequence, Arms and Shoulders, Gentle Spinal Twist, Apanasana. Standing Poses for Strength and Balance, to enhance function and confidence. Practices: Mountain Pose, Flying Crane Sequence, Tree Pose, Warrior 2 and Side Angle. Relaxation- Practice concludes with guided relaxation to quiet the mind and calm the body. Practices: Seated Mountain Pose, even breath, extended exhalation,Yoga Nidra.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Joel Morgenlander, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): September 23, 2019
• Study Completion (Actual): September 23, 2019

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Yoga; Mindfulness
• Other Study ID Numbers: pro00086819

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