A Study on the Effect of Mindfulness-based Yoga on Youth With Persistent Concussion Symptoms

Mild Traumatic Brain Injury Clinical Trial

Official title:

A Pilot Study on the Effect of Mindfulness-based Yoga on Youth With Persistent Concussion Symptoms: Bridging Neurophysiological and Functional Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217695
• Other study ID #: BloorviewKR_MBY
• Status: Completed
• Phase: N/A
• First received: June 19, 2017
• Last updated: July 12, 2017
• Start date: April 4, 2016
• Est. completion date: October 7, 2016

Study information

• Verified date: June 2017
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mild traumatic brain injury (mTBI), also known as concussion, is of great concern in the youth population, with incidences of injury steadily increasing within the past few years. Current Canadian estimates have indicated that the total rate of concussions per 100,000 increased from 467 to 754 for boys and from 209 to 441 for girls from 2003-2010. As defined by the recent Zurich Consensus statement, concussion is a pathophysiological injury induced by biomechanical forces, which can be caused by impact to the head, neck or body. In 10-20% of youth, concussion symptoms persist in the weeks, months or even years following the injury. Consequently, youth with persistent concussion symptoms are unable to fully participate in the meaningful activities (e.g. attending school, engaging with friends and community) they did prior to the injury and experience a reduced quality of life.

Persistent concussion symptoms in youth requires an approach that directly addresses the rumination and attention to distressful thoughts about their functional performance, while still promoting appropriate levels of physical and cognitive demands. Targeting these constructs may shift the focus away from symptoms, while building self-efficacy and enhancing participation in daily activities. Mindfulness-based yoga (MBY) is a mind-body intervention that uses physical yoga poses, purposeful breathing techniques and a focus on being in the present moment. MBY encourages participants to develop moment-to-moment awareness of physical sensations, emotions, and thoughts, and promotes the cultivation of non-judgemental and accepting relationships to personal experiences. In chronic pain, fibromyalgia, mental health and now TBI populations, MBY has demonstrated benefits in physical (i.e. increased muscle strength, endurance), psychological (i.e. decreased stress, increased self-efficacy), cognitive (i.e. increased concentration) and social (i.e. emotional regulation, improved mood) domains. Although mindfulness based yoga has been validated as a form of rehabilitation in the adult population, its applicability for youth with persistent concussion symptoms has yet to be explored. Understanding the impact of a MBY intervention on this population may enhance management of persistent symptoms and ultimately, participation in meaningful activities.

In addition to the functional sequelae that ensue following this injury, concussion in both the acute and persistent phases is being recognized as a neurophysiological injury. Traditional methods of assessment following concussion place emphasis on subjective self-report and administration of neuropsychological batteries. These assessments are used in an effort to return the youth to activity (i.e school, sport). However, these methods can be unreliable as youth have a high incentive to return to play and neurocognitive resolution does not necessarily equate to pre-injury function. To augment these measures, an objective indicator of neurophysiological stress is needed. Heart rate variability (HRV) is an objective, neurophysiological indicator of autonomic nervous system functioning. HRV is quantified by measuring the time intervals between heartbeats. Increased variability in heart rate (i.e. increased HRV) is seen as healthy neurophysiological function, demonstrating an individual's ability to adapt and be flexible to the demands of the environment. Conversely, decreased HRV is demonstrative of an individual's reduced ability to respond flexibly to their environment. Investigating the impact of persistent concussion symptoms on HRV has the potential to enhance our understanding of autonomic nervous system functioning in the chronic phases of this injury for an understudied population.

The specific objectives are to: (1) adapt the MBY intervention protocol to suit the unique needs of youth with mTBI (i.e. safety, fatigue), (2) collect data on the impact of MBY on HRV, self-efficacy and participation, (3) describe changes in HRV, self-efficacy and participation associated with MBY across pre-intervention, post-intervention and 3 months following intervention, (4) identify if post concussion symptoms change (i.e. increase or decrease) following MBY and (5) identify if changes in post concussion symptoms occur with changes in HRV, self-efficacy and participation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 7, 2016
• Est. primary completion date: October 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Youth between 13-18 years old;

• Persistent concussion symptoms greater than 1 month.

Exclusion Criteria:

• Less than 13 years old or greater than 18 years old;

• Non-English speaking;

• Severe (unmanaged) psychiatric diagnosis;

• Neurological disease;

• Diagnosed cardiac issues.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Mild Traumatic Brain Injury

Intervention

Behavioral:
• Mindfulness-based Yoga Arm

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hopsital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	Canadian Institutes of Health Research; Ontario Neurotrauma Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (17)

Abaji JP, Curnier D, Moore RD, Ellemberg D. Persisting Effects of Concussion on Heart Rate Variability during Physical Exertion. J Neurotrauma. 2016 May 1;33(9):811-7. doi: 10.1089/neu.2015.3989. Epub 2015 Oct 8. — View Citation

Azulay J, Smart CM, Mott T, Cicerone KD. A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild traumatic brain injury/postconcussive syndrome. J Head Trauma Rehabil. 2013 Jul-Aug;28(4):323-31. doi: 10.1097/HTR.0b013e318250ebda. — View Citation

Belanger HG, Kretzmer T, Vanderploeg RD, French LM. Symptom complaints following combat-related traumatic brain injury: relationship to traumatic brain injury severity and posttraumatic stress disorder. J Int Neuropsychol Soc. 2010 Jan;16(1):194-9. doi: 10.1017/S1355617709990841. Epub 2009 Sep 17. — View Citation

Blechert J, Michael T, Grossman P, Lajtman M, Wilhelm FH. Autonomic and respiratory characteristics of posttraumatic stress disorder and panic disorder. Psychosom Med. 2007 Dec;69(9):935-43. Epub 2007 Nov 8. — View Citation

Conder RL, Conder AA. Heart rate variability interventions for concussion and rehabilitation. Front Psychol. 2014 Aug 13;5:890. doi: 10.3389/fpsyg.2014.00890. eCollection 2014. Review. — View Citation

Deshpande S, Nagendra HR, Nagarathna R. A randomized control trial of the effect of yoga on Gunas (personality) and Self esteem in normal healthy volunteers. Int J Yoga. 2009 Jan;2(1):13-21. doi: 10.4103/0973-6131.43287. — View Citation

Galantino ML, Galbavy R, Quinn L. Therapeutic effects of yoga for children: a systematic review of the literature. Pediatr Phys Ther. 2008 Spring;20(1):66-80. doi: 10.1097/PEP.0b013e31815f1208. Review. — View Citation

Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. — View Citation

Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555. — View Citation

Jonsson C, Andersson EE. Mild traumatic brain injury: a description of how children and youths between 16 and 18 years of age perform leisure activities after 1 year. Dev Neurorehabil. 2013;16(1):1-8. doi: 10.3109/17518423.2012.704955. Epub 2012 Oct 3. — View Citation

King GA, Law M, King S, Hurley P, Hanna S, Kertoy M, Rosenbaum P. Measuring children's participation in recreation and leisure activities: construct validation of the CAPE and PAC. Child Care Health Dev. 2007 Jan;33(1):28-39. — View Citation

Leddy JJ, Kozlowski K, Fung M, Pendergast DR, Willer B. Regulatory and autoregulatory physiological dysfunction as a primary characteristic of post concussion syndrome: implications for treatment. NeuroRehabilitation. 2007;22(3):199-205. Review. — View Citation

Macpherson A, Fridman L, Scolnik M, Corallo A, Guttmann A. A population-based study of paediatric emergency department and office visits for concussions from 2003 to 2010. Paediatr Child Health. 2014 Dec;19(10):543-6. — View Citation

McCrory P, Meeuwisse W, Aubry M, Cantu B, Dvorák J, Echemendia R, Engebretsen L, Johnston K, Kutcher J, Raftery M, Sills A, Benson B, Davis G, Ellenbogen R, Guskiewicz K, Herring SA, Iverson G, Jordan B, Kissick J, McCrea M, McIntosh A, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator C, Turner M. Consensus statement on Concussion in Sport - The 4th International Conference on Concussion in Sport held in Zurich, November 2012. Phys Ther Sport. 2013 May;14(2):e1-e13. doi: 10.1016/j.ptsp.2013.03.002. — View Citation

Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x. Review. — View Citation

Reed N, Murphy J, Dick T, Mah K, Paniccia M, Verweel L, Dobney D, Keightley M. A multi-modal approach to assessing recovery in youth athletes following concussion. J Vis Exp. 2014 Sep 25;(91):51892. doi: 10.3791/51892. — View Citation

Zemek RL, Farion KJ, Sampson M, McGahern C. Prognosticators of persistent symptoms following pediatric concussion: a systematic review. JAMA Pediatr. 2013 Mar 1;167(3):259-65. doi: 10.1001/2013.jamapediatrics.216. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Children's Assessment of Participation and Employment (CAPE) from pre-intervention to 3 month follow-up	Participants are asked to complete the 55-item questionnaire and answer questions about an activity based on five dimensions of participation: diversity (number of activities done), intensity, (with whom the youth does an activity with), where (they do it) and enjoyment of activities (King et al., 2007).	Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Primary	Change in Self-Efficacy Questionnaire for Children (SEQ-C) from pre-intervention to 3 month follow-up	Participants are asked to rate their perceived ability to accomplish a task between 1 (not at all) to 5 (very well). The questions cover three domains of self-efficacy, namely social, academic and emotional.	Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Primary	Change in Heart rate variability from pre-intervention to 3 month follow-up	Time (seconds) of beat-to-beat intervals, measured over a 24 hour recording	Pre-intervention, during each of the 8 weeks of mindfulness-based yoga (for 24 hours starting at 6PM when each of the yoga sessions begins until 6PM the following day), post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Secondary	Post-Concussion Symptom Inventory (PCSI)	It is a 21-item self-report measure where symptom severity is rated on a scale of 0 to 6 (0= not at all, 3= moderate, 6=severe) for symptoms that occur within physical, cognitive, fatigue and emotional domains	Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
Secondary	Godin Leisure-Time Exercise Questionnaire (GLTE)	It is a self-report measure that assesses weekly physical activity engagement by asking participants to indicate how many times per week they engage in strenuous (heart beats rapidly), moderate (not exhausting) or mild exercise (minimal effort).	Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up