Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03304327
Other study ID # pro00086819
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2017
Est. completion date September 23, 2019

Study information

Verified date March 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date September 23, 2019
Est. primary completion date September 23, 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale. up to 7 days
See also
  Status Clinical Trial Phase
Completed NCT05562544 - EEG Diagnostic for Repetitive Sub-concussive Head Impacts
Terminated NCT02988609 - Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI N/A
Completed NCT02710123 - Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion N/A
Terminated NCT02100150 - A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI) Phase 2
Active, not recruiting NCT01874847 - PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin Phase 2/Phase 3
Completed NCT01903525 - DHA For The Treatment of Pediatric Concussion Related to Sports Injury Phase 1
Completed NCT02262507 - Concussion Device Audiological Measures N/A
Enrolling by invitation NCT05948501 - The Effects of Concussion on Gait and Posture in Individuals With Peripheral Vision Loss
Withdrawn NCT02643836 - Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome N/A
Recruiting NCT03360786 - Primary Prevention of Concussion in Youth Ice Hockey Players N/A
Recruiting NCT03710109 - Evaluation of an EEG Based Concussion System
Not yet recruiting NCT02930395 - Blood Biomarkers for the Management of Concussion in Professional Rugby Players N/A
Completed NCT02271451 - Q-collar and Brain Injury Biomarkers N/A
Completed NCT02268240 - Care for Post-Concussive Symptoms N/A
Completed NCT02278029 - Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment N/A
Completed NCT02268058 - Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children N/A
Active, not recruiting NCT03608722 - Video Games to Track Cognitive Health N/A
Completed NCT02660164 - A Study to Assess the Effectiveness of the Nautilus BrainPulseâ„¢ as an Aid in the Diagnosis of Concussion
Completed NCT02556177 - Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 N/A
Completed NCT02344446 - Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion N/A