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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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

6

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 13 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Children's Assessment of Participation and Employment (CAPE) from pre-intervention to 3 month follow-up
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post-Concussion Symptom Inventory (PCSI)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 aprile 2016

Completamento primario (Effettivo)

7 ottobre 2016

Completamento dello studio (Effettivo)

7 ottobre 2016

Date di iscrizione allo studio

Primo inviato

19 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

12 luglio 2017

Primo Inserito (Effettivo)

14 luglio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 luglio 2017

Ultimo verificato

1 giugno 2017

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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