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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.

調査の概要

研究の種類

介入

入学 (実際)

6

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ontario
      • Toronto、Ontario、カナダ、M4G 1R8
        • Holland Bloorview Kids Rehabilitation Hopsital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

13年~18年 (子、大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Children's Assessment of Participation and Employment (CAPE) from pre-intervention to 3 month follow-up
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Post-Concussion Symptom Inventory (PCSI)
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Nick Reed, MScOT, PhD、Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年4月4日

一次修了 (実際)

2016年10月7日

研究の完了 (実際)

2016年10月7日

試験登録日

最初に提出

2017年6月19日

QC基準を満たした最初の提出物

2017年7月12日

最初の投稿 (実際)

2017年7月14日

学習記録の更新

投稿された最後の更新 (実際)

2017年7月14日

QC基準を満たした最後の更新が送信されました

2017年7月12日

最終確認日

2017年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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