NCT03304327

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

October 3, 2017

Last Update Submit

March 25, 2020

Conditions

Keywords

YogaMindfulness

Outcome Measures

Primary Outcomes (1)

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

    up to 7 days

Study Arms (1)

Mindfullness and Yoga

EXPERIMENTAL

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

Interventions

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.

Mindfullness and Yoga

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joel Morgenlander

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 9, 2017

Study Start

September 27, 2017

Primary Completion

September 23, 2019

Study Completion

September 23, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations