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

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

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Werkelijk)

6

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Ontario
      • Toronto, Ontario, Canada, M4G 1R8
        • Holland Bloorview Kids Rehabilitation Hopsital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mindfulness-based Yoga Arm
8-week period, 1x/week for 45-60 minutes/session. Sessions 1-2: Participants instructed to focus their attention on their breath, and the physical sensations in their bodies while holding the yoga postures, to develop sustained and focused attention. Sessions 3-4: exploring the sensorial qualities of physical sensation in the body whether pleasant or unpleasant and to notice thoughts and label them (e.g., "planning", "remembering"), and to the same with emotions (e.g., "worry", "frustration", "fear") to practice disengaging from automatic associative thinking. Session 6-8: Instructor will guide participants to allow sensations of discomfort or effort to be as they are and to bring awareness to automatic patterns of reactivity. The goal is to foster distress tolerance, provide opportunities for participants to practice self-care, and allow an opportunity to observe and respond skillfully, instead of react automatically, to unpleasant stimuli (sensations, emotions).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Children's Assessment of Participation and Employment (CAPE) from pre-intervention to 3 month follow-up
Tijdsspanne: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 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
Change in Self-Efficacy Questionnaire for Children (SEQ-C) from pre-intervention to 3 month follow-up
Tijdsspanne: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 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
Change in Heart rate variability from pre-intervention to 3 month follow-up
Tijdsspanne: 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
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Post-Concussion Symptom Inventory (PCSI)
Tijdsspanne: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
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
Godin Leisure-Time Exercise Questionnaire (GLTE)
Tijdsspanne: Pre-intervention, post-intervention (within 1 week following 8-week intervention), 3 month follow-up
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Nick Reed, MScOT, PhD, Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 april 2016

Primaire voltooiing (Werkelijk)

7 oktober 2016

Studie voltooiing (Werkelijk)

7 oktober 2016

Studieregistratiedata

Eerst ingediend

19 juni 2017

Eerst ingediend dat voldeed aan de QC-criteria

12 juli 2017

Eerst geplaatst (Werkelijk)

14 juli 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

12 juli 2017

Laatst geverifieerd

1 juni 2017

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There is no plan to share individual participant data with other researchers.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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