- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03217695
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
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M4G 1R8
- Holland Bloorview Kids Rehabilitation Hopsital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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
Collaboratori
Investigatori
- Investigatore principale: Nick Reed, MScOT, PhD, Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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. No abstract available.
- 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.
- 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.
- 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.
- 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. doi: 10.1097/PSY.0b013e31815a8f6b. Epub 2007 Nov 8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1111/j.1365-2214.2006.00613.x.
- 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. doi: 10.1093/pch/19.10.543.
- McCrory P, Meeuwisse W, Aubry M, Cantu B, Dvorak 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. No abstract available.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BloorviewKR_MBY
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .
Prove cliniche su Commozione cerebrale
-
University of PadovaReclutamentoAnestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletato
-
University of PadovaCompletato
-
University of PadovaCompletatoPropofol | Anestesia Brain MonitoringItalia
-
University of PadovaCompletatoLidocaina | Anestesia Brain MonitoringItalia
-
University of PadovaReclutamentoPropofol | Remifentanil | Anestesia Brain MonitoringItalia
-
University of Dublin, Trinity CollegeSconosciutoBrain Health Atleti d'élite in pensione
-
University of EdinburghNHS LothianNon ancora reclutamentoDeterioramento cognitivo | Anestesia | Compromissione cognitiva, lieve | Anestesia Brain Monitoring | Compromissione cognitiva, progressiva | Monitoraggio della profondità dell'anestesiaRegno Unito
Prove cliniche su Mindfulness-based Yoga Arm
-
Walter Reed Army Institute of Research (WRAIR)U.S. Army Medical Research and Development Command; U.S. Army Training and Doctrine...CompletatoDolore | Fatica | Salute, Soggettiva | Sonno | Ansia | Sintomi depressivi | Stato d'animo | Comando | Regolazione delle emozioni | Yoga | Consapevolezza | Lesione muscoloscheletrica | Operazioni militari | Coesione, socialeStati Uniti
-
Oregon Health and Science UniversityJohn & Tami Marick FoundationNon ancora reclutamentoDepressione perinatale
-
University of MiamiUnited States Department of DefenseTerminato
-
Wayne State UniversityChandler Park Academy; Jefferson Middle School; Lakeview Public SchoolsNon ancora reclutamentoAnsia | Trauma | Disturbo post traumatico da stressStati Uniti
-
University of Alabama at BirminghamRitiratoStress, Psicologico
-
Sam Houston State UniversityTerminato
-
Canandaigua VA Medical CenterCompletatoLombalgia cronicaStati Uniti
-
Universidad Pontificia de SalamancaMinisterio de Ciencia e Innovación, SpainCompletatoRisposta infiammatoria | Benessere | Salute mentale | Consapevolezza | Salute cardiovascolare | Auto compassioneSpagna
-
Eric LoucksSconosciutoAttività fisica | Stress, Psicologico | Sonno | Sintomi depressivi | Dieta | Comportamento sedentario | Solitudine | Regolazione emotiva | Consapevolezza | Consumo di alcol, giovaniStati Uniti
-
University of Southern CaliforniaNational Institute on Drug Abuse (NIDA)Completato