StrokeSTROKE-TRICNCT02296268
Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke
An observational study of Stroke, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic Exercise Screening and Prescription Clinic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2016to 26 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients post-stroke
Who may be able to join
- Male or female adults
- Diagnosed with ischemic or hemorrhagic stroke
- Referred to NSRC for stroke rehabilitation
Who cannot join
- Have contraindications to exercise testing using American College of Sports Medicine guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Aerobic Exercise Screening and Prescription Clinic
- Keywords
- stroke, aerobic exercise, screening, prescription
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise Screening and Prescription ClinicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: admission and discharge (baseline and 5-6 weeks later)
Secondary outcomes (6)
Change from admission 10-Meter Walk at discharge
To assess change between admission and discharge in n walking speed over a 10-metre distance
Measured: admission and discharge (baseline and ~5-6 weeks later)
Change from admission resting blood pressure at discharge
To assess change between admission and discharge in resting systolic and diastolic blood pressure
Measured: admission and discharge (baseline and 5-6 weeks later)
Change from admission abdominal girth at discharge
To assess change between admission and discharge in waist circumference in relaxed standing position
Measured: admission and discharge
Change from admission Stroke-Specific Quality of Life at discharge
To assess change between admission and discharge in quality of life questionnaire
Measured: admission and discharge (baseline and 5-6 weeks later)
Change from admission Readiness for Physical Activity Scale at discharge
To assess change between admission and discharge in readiness to engage in physical activity
Measured: admission and discharge (baseline and 5-6 weeks later)
Change from admission Fatigue Severity Scale at discharge
To assess change between admission and discharge in level of fatigue
Measured: admission and discharge (baseline and 5-6 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start30 Jan 2016
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn MacKay-Lyons, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296268
- Sponsor's protocol ID
- CDHA-RS 2015-223
- Acronym
- STROKE-TRIC
- Status last verified
- Mar 2018
- First submitted
- 14 Nov 2014
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to disseminate the findings through a peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepping up Aerobic Exercise to Improve Health Outcomes After Stroke: Translating Research Into Clinical Care
- ClinicalTrials.gov ID
- NCT02296268
- Acronym / sponsor ID
- STROKE-TRIC / CDHA-RS 2015-223
- Conditions
- Stroke
- Keywords
- stroke, aerobic exercise, screening, prescription
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Clinic Stroke Group | – | Behavioral: Aerobic Exercise Screening and Prescription ClinicIn- 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). |
| Post-Clinic Stroke Group | – | Behavioral: Aerobic Exercise Screening and Prescription ClinicIn- 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients post-stroke
Key inclusion criteria (3 listed)
- Male or female adults
- Diagnosed with ischemic or hemorrhagic stroke
- Referred to NSRC for stroke rehabilitation
Key exclusion criteria (1 listed)
- Have contraindications to exercise testing using American College of Sports Medicine guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise Screening and Prescription ClinicPatients 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. | Behavioural | Post-Clinic Stroke Group, Pre-Clinic Stroke Group |
Primary outcome
Change from admission 6-Minute Walk Test at discharge
Time frame: 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
6 secondary outcomes
Change from admission 10-Meter Walk at discharge
Time frame: admission and discharge (baseline and ~5-6 weeks later)
Change from admission resting blood pressure at discharge
Time frame: admission and discharge (baseline and 5-6 weeks later)
Change from admission abdominal girth at discharge
Time frame: admission and discharge
Change from admission Stroke-Specific Quality of Life at discharge
Time frame: admission and discharge (baseline and 5-6 weeks later)
Change from admission Readiness for Physical Activity Scale at discharge
Time frame: admission and discharge (baseline and 5-6 weeks later)
Change from admission Fatigue Severity Scale at discharge
Time frame: admission and discharge (baseline and 5-6 weeks later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Individual participant dataSharing planned: No. We plan to disseminate the findings through a peer-reviewed publication.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from admission 6-Minute Walk Test at discharge (time frame: admission and discharge (baseline and 5-6 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.