NCT02296268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 30, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

November 14, 2014

Last Update Submit

March 21, 2018

Conditions

Keywords

strokeaerobic exercisescreeningprescription

Outcome Measures

Primary Outcomes (1)

  • Change from admission 6-Minute Walk Test at discharge

    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)

Secondary Outcomes (6)

  • Change from admission 10-Meter Walk at discharge

    admission and discharge (baseline and ~5-6 weeks later)

  • Change from admission resting blood pressure at discharge

    admission and discharge (baseline and 5-6 weeks later)

  • Change from admission abdominal girth at discharge

    admission and discharge

  • Change from admission Stroke-Specific Quality of Life at discharge

    admission and discharge (baseline and 5-6 weeks later)

  • Change from admission Readiness for Physical Activity Scale at discharge

    admission and discharge (baseline and 5-6 weeks later)

  • +1 more secondary outcomes

Study Arms (3)

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

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

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.

Interventions

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 GroupPre-Clinic Stroke Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients post-stroke

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H3J5, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliated Scientist

Study Record Dates

First Submitted

November 14, 2014

First Posted

November 20, 2014

Study Start

January 30, 2016

Primary Completion

January 26, 2018

Study Completion

January 26, 2018

Last Updated

March 23, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

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

Locations