Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke (STROKE-TRIC)
21 marzo 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
62
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
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada, B3H3J5
- QEII Health Sciences Centre
-
-
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
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patients post-stroke
Descrizione
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
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
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from admission 6-Minute Walk Test at discharge
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from admission 10-Meter Walk at discharge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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)
30 gennaio 2016
Completamento primario (Effettivo)
26 gennaio 2018
Completamento dello studio (Effettivo)
26 gennaio 2018
Date di iscrizione allo studio
Primo inviato
14 novembre 2014
Primo inviato che soddisfa i criteri di controllo qualità
18 novembre 2014
Primo Inserito (Stima)
20 novembre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 marzo 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 marzo 2018
Ultimo verificato
1 marzo 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CDHA-RS 2015-223
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
We plan to disseminate the findings through a peer-reviewed publication.
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 .