Mindfulness and Yoga Training for Athle… | Clinical Trial

Key information

Conditions

Concussion Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness and Yoga Training

Behavioral

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.

Primary outcomes

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

Time frame: up to 7 days

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: (MYTAC)

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Oct 9, 2017
Registry last updated: Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed