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

Sponsor
Nova Scotia Health Authority (Other)
Overall Status
Completed
CT.gov ID
NCT02296268
Collaborator
(none)
62
1
23.9
2.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Aerobic Exercise Screening and Prescription Clinic

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
62 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke: Translating Research Into Clinical Care
Actual Study Start Date :
Jan 30, 2016
Actual Primary Completion Date :
Jan 26, 2018
Actual Study Completion Date :
Jan 26, 2018

Arms and Interventions

Arm Intervention/Treatment
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).

Behavioral: Aerobic Exercise Screening and Prescription Clinic
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).

Behavioral: Aerobic Exercise Screening and Prescription Clinic
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.

Outcome Measures

Primary Outcome Measures

  1. Change from admission 6-Minute Walk Test at discharge [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

Secondary Outcome Measures

  1. Change from admission 10-Meter Walk at discharge [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

  2. Change from admission resting blood pressure at discharge [admission and discharge (baseline and 5-6 weeks later)]

    To assess change between admission and discharge in resting systolic and diastolic blood pressure

  3. Change from admission abdominal girth at discharge [admission and discharge]

    To assess change between admission and discharge in waist circumference in relaxed standing position

  4. Change from admission Stroke-Specific Quality of Life at discharge [admission and discharge (baseline and 5-6 weeks later)]

    To assess change between admission and discharge in quality of life questionnaire

  5. Change from admission Readiness for Physical Activity Scale at discharge [admission and discharge (baseline and 5-6 weeks later)]

    To assess change between admission and discharge in readiness to engage in physical activity

  6. Change from admission Fatigue Severity Scale at discharge [admission and discharge (baseline and 5-6 weeks later)]

    To assess change between admission and discharge in level of fatigue

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 QEII Health Sciences Centre Halifax Nova Scotia Canada B3H3J5

Sponsors and Collaborators

  • Nova Scotia Health Authority

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marilyn MacKay-Lyons, Affiliated Scientist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT02296268
Other Study ID Numbers:
  • CDHA-RS 2015-223
First Posted:
Nov 20, 2014
Last Update Posted:
Mar 23, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marilyn MacKay-Lyons, Affiliated Scientist, Nova Scotia Health Authority
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2018