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Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke (STROKE-TRIC)

2018年3月21日 更新者:Marilyn MacKay-Lyons、Nova Scotia Health Authority

Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke: Translating Research Into Clinical Care

Stroke is a leading cause of chronic disability here in Nova Scotia and globally. Aerobic exercise is known to improve health by increasing energy levels, physical mobility, balance, bone health, cardiovascular risk reduction, mental well-being, cognition, sleep, and quality of life. Nonetheless, people remain woefully inactive after stroke, regardless if they are in hospital or at home. The current investigative team and others have shown that even during physiotherapy, exercise intensity is not adequate to increase physical fitness. Consequently, patients are often deprived of a treatment that could improve their recovery. Why does this gap between evidence and clinical practice persist? Through a national survey the current team found that an important contributing factor is lack of appropriate screening (especially stress tests) to ensure that patients are safe to engage in aerobic exercise. This project is designed to close this evidence-practice gap by establishing a state-of-the-art aerobic exercise screening and prescription clinic at the Nova Scotia Rehabilitation Centre (NSRC). The intent is to compare outcomes of stroke rehabilitation participants before and after the clinic is underway and determine if the clinic has a positive effect on the confidence of NSRC physiotherapists to use aerobic exercise safely and effectively in stroke rehabilitation.

調査の概要

詳細な説明

Research question: To what extent does an on-site aerobic exercise screening and prescription clinic effect uptake of aerobic exercise and patient outcomes in in-patient stroke rehabilitation?

Design: Pre-post cohort design to explore real-world application and feasibility

Aim 1. Establish an aerobic exercise screening and prescription clinic (herein 'Aerobics Clinic') at the NSRC.

Aim 2. Assess the potential impact of the Aerobics Clinic on the self-efficacy of physiotherapists at NSRC regarding clinical utilization of aerobic exercise in in-patient stroke rehabilitation.

Method: An assessment of the physiotherapy participants' self-efficacy regarding the clinical utilization of aerobic exercise post-stroke will be conducted prior to, and after, implementation of the Clinic.

Aim 3: Assess the potential impact of the Aerobics Clinic on prescription and treatment practices regarding aerobic exercise among patients in stroke rehabilitation at the NSRC.

Method: Prior to, and after, implementation of the Clinic the actual utilization of aerobic exercise in the practices of the physiotherapy participants will be assessed using heart rate monitoring, activity monitoring, and health record review.

研究の種類

観察的

入学 (実際)

62

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

    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H3J5
        • QEII Health Sciences Centre

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

18年歳以上 (大人、高齢者)

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

サンプリング方法

非確率サンプル

調査対象母集団

Patients post-stroke

説明

Inclusion Criteria:

  • Male or female adults
  • Diagnosed with ischemic or hemorrhagic stroke
  • Referred to NSRC for stroke rehabilitation

Exclusion Criteria:

  • Have contraindications to exercise testing using American College of Sports Medicine guidelines

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

コホートと介入

グループ/コホート
介入・治療
Pre-Clinic Stroke Group
In- or out-patients with diagnosis of ischemic or hemorrhagic stroke who have been referred to the NSRC prior to the establishment of the Clinic and are willing/able to provide written informed consent and have no contraindications to exercise testing. Utilization of aerobic exercise will be monitored during their physiotherapy sessions (Aim 3).
Patients will be referred to the Clinic by their physiotherapist to be assessed regarding their safety and readiness to participate in aerobic training. If they are deemed to be safe and ready, an aerobic exercise prescription will be written to guide the implementation of a safe and effective training protocol. Patients deemed to be at moderate to high risk will need to be cleared for testing by a physician on the stroke service. A cardiologist will be consulted about specific concerns re cardiac status.
Post-Clinic Stroke Group
In- or out-patients with diagnosis of ischemic or hemorrhagic stroke who have been referred to the NSRC after the establishment of the Clinic and are willing/able to provide written informed consent and have no contraindications to exercise testing. Each patient will undergo an assessment in the Aerobics Clinic and will receive a prescription for aerobic training based on the assessment findings. Utilization of aerobic exercise will be monitored during their physiotherapy sessions (Aim 3).
Patients will be referred to the Clinic by their physiotherapist to be assessed regarding their safety and readiness to participate in aerobic training. If they are deemed to be safe and ready, an aerobic exercise prescription will be written to guide the implementation of a safe and effective training protocol. Patients deemed to be at moderate to high risk will need to be cleared for testing by a physician on the stroke service. A cardiologist will be consulted about specific concerns re cardiac status.
Stroke Rehabilitation Physiotherapists
Physiotherapists whose current practice involves working full-time or part-time on in- or out-patient stroke service at the NSRC. Their self-efficacy regarding the clinical utilization of aerobic exercise post-stroke will be conducted prior to, and after, implementation of the Aerobics Clinic.

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 from admission 6-Minute Walk Test at discharge
時間枠:admission and discharge (baseline and 5-6 weeks later)
To assess change between admission and discharge in distance walked without manual support in 6 minutes
admission and discharge (baseline and 5-6 weeks later)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from admission 10-Meter Walk at discharge
時間枠:admission and discharge (baseline and ~5-6 weeks later)
To assess change between admission and discharge in n walking speed over a 10-metre distance
admission and discharge (baseline and ~5-6 weeks later)
Change from admission resting blood pressure at discharge
時間枠:admission and discharge (baseline and 5-6 weeks later)
To assess change between admission and discharge in resting systolic and diastolic blood pressure
admission and discharge (baseline and 5-6 weeks later)
Change from admission abdominal girth at discharge
時間枠:admission and discharge
To assess change between admission and discharge in waist circumference in relaxed standing position
admission and discharge
Change from admission Stroke-Specific Quality of Life at discharge
時間枠:admission and discharge (baseline and 5-6 weeks later)
To assess change between admission and discharge in quality of life questionnaire
admission and discharge (baseline and 5-6 weeks later)
Change from admission Readiness for Physical Activity Scale at discharge
時間枠:admission and discharge (baseline and 5-6 weeks later)
To assess change between admission and discharge in readiness to engage in physical activity
admission and discharge (baseline and 5-6 weeks later)
Change from admission Fatigue Severity Scale at discharge
時間枠:admission and discharge (baseline and 5-6 weeks later)
To assess change between admission and discharge in level of fatigue
admission and discharge (baseline and 5-6 weeks later)

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。

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1月30日

一次修了 (実際)

2018年1月26日

研究の完了 (実際)

2018年1月26日

試験登録日

最初に提出

2014年11月14日

QC基準を満たした最初の提出物

2014年11月18日

最初の投稿 (見積もり)

2014年11月20日

学習記録の更新

投稿された最後の更新 (実際)

2018年3月23日

QC基準を満たした最後の更新が送信されました

2018年3月21日

最終確認日

2018年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CDHA-RS 2015-223

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

We plan to disseminate the findings through a peer-reviewed publication.

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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