Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke

Stroke Clinical Trial

— STROKE-TRIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296268
• Other study ID #: CDHA-RS 2015-223
• Status: Completed
• First received: November 14, 2014
• Last updated: March 21, 2018
• Start date: January 30, 2016
• Est. completion date: January 26, 2018

Study information

• Verified date: March 2018
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: January 26, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from admission 10-Meter Walk at discharge	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)
Secondary	Change from admission resting blood pressure at discharge	To assess change between admission and discharge in resting systolic and diastolic blood pressure	admission and discharge (baseline and 5-6 weeks later)
Secondary	Change from admission abdominal girth at discharge	To assess change between admission and discharge in waist circumference in relaxed standing position	admission and discharge
Secondary	Change from admission Stroke-Specific Quality of Life at discharge	To assess change between admission and discharge in quality of life questionnaire	admission and discharge (baseline and 5-6 weeks later)
Secondary	Change from admission Readiness for Physical Activity Scale at discharge	To assess change between admission and discharge in readiness to engage in physical activity	admission and discharge (baseline and 5-6 weeks later)
Secondary	Change from admission Fatigue Severity Scale at discharge	To assess change between admission and discharge in level of fatigue	admission and discharge (baseline and 5-6 weeks later)