StrokeNCT02681393
Physical Activity Maintenance in Stroke
A study testing Brochure and Telephone Support and Brochure in people with Stroke, run by McMaster University at 1 site in Canada.
Trial summary
It is essential that individuals living with stroke engage in physical activity to improve cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This objective of this study is to examine the effectiveness of an educational brochure that promotes exercise in people with stroke, combined… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Brochure and Telephone Support and Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Jan 2017
- Phase
- Interventional
- 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
Who may be able to join
- Completed the intervention arm of a previous trial (Fit for Function)
- Living in the community
- Not involved in active rehabilitation
Who cannot join
- Musculoskeletal contraindications to exercise
- Unstable cardiovascular conditions
- Unstable medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of an Educational Brochure on Exercise and a Motivational Telephone Support in Physical Activity Maintenance for Stroke Survivors
It is essential that individuals living with stroke engage in physical activity to improve cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This objective of this study is to examine the effectiveness of an educational brochure that promotes exercise in people with stroke, combined with a motivational telephone support, on maintaining physical activity. Fifty participants with stroke will be enrolled. This study will provide insight into implementing effective tools that are designed to help individuals with stroke maintain physically active behaviours in the long-term.
Read the detailed description
Study Design
This is a 4-week randomized controlled trial consisting of two groups: 1) participants who receive an educational brochure regarding physical activity after stroke, combined with motivational telephone support (intervention group), and 2) participants who receive the educational brochure alone (control group).
Interventions
Participants in the control group will be asked to devote approximately 30 minutes of their time to this study over the course of 4 weeks, and those in the intervention group will be involved for a total of 85 minutes.
- Educational Brochure (both intervention and control groups): The educational brochure, Aerobic Exercise After Stroke, will be provided to all participants in the study. The brochure was created by researchers from the Canadian Partnership for Stroke Recovery and written for a stroke audience. It was designed to educate individuals with stroke about the benefits of aerobic exercise, exercise intensity, and provide a sample program.
- Motivational Telephone Support (intervention group only): Motivational telephone support is an inexpensive way of supplementing the educational brochure for facilitating physical activity behaviors by establishing a personal connection and providing ongoing support and motivation. Participants in the intervention group will receive a total of 4 phone calls that will take place at 1-week intervals. Each telephone session will last approximately 15 minutes, where issues regarding ongoing physical activity, such as relapses and road blocks, will be addressed. Also, ongoing motivation and support will be provided as needed to re-direct participants back onto the path of physical activity engagement.
Statistical Analyses
Baseline participant characteristics will be analyzed using descriptive statistics. A two-way analysis on variance will be used to compare mean differences in physical activity and self-efficacy between the intervention and control group considering a group X time interaction
- Conditions
- Stroke
- Being tested
- Brochure and Telephone Support, Brochure
- Keywords
- Physical activity, brochures, telephone support, stroke
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brochure and Telephone SupportBehavioural
Participants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls.
BrochureBehavioural
Participants will receive both the Aerobic Exercise After Stroke educational brochure.
| Study group | Role | What they receive |
|---|---|---|
| Brochure and Telephone Support | Experimental | Participants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls. Receives: Behavioral: Brochure and Telephone Support |
| Brochure Only | Active comparator | Participants will receive the Aerobic Exercise After Stroke educational brochure only. Receives: Behavioral: Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Rapid Assessment of Physical Activity questionnaire
Measured: 4 weeks
Secondary outcomes (1)
Physical Activity Self-Efficacy
General Self-Efficacy Scale.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ada Tang, McMaster University
- Investigators
- Ada Tang, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681393
- Sponsor's protocol ID
- PA Maintenance in Stroke
- Status last verified
- Mar 2017
- First submitted
- 4 Feb 2016
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available.
Publications
Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
PubMed 24846875
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Educational Brochure on Exercise and a Motivational Telephone Support in Physical Activity Maintenance for Stroke Survivors
- ClinicalTrials.gov ID
- NCT02681393
- Acronym / sponsor ID
- PA Maintenance in Stroke
- Conditions
- Stroke
- Keywords
- Physical activity, brochures, telephone support, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 12 Feb 2016 (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.
It is essential that individuals living with stroke engage in physical activity to improve cardiovascular risk factors and reduce the risk of stroke (Billinger et al, 2014). This objective of this study is to examine the effectiveness of an educational brochure that promotes exercise in people with stroke, combined with a motivational telephone support, on maintaining physical activity. Fifty participants with stroke will be enrolled. This study will provide insight into implementing effective tools that are designed to help individuals with stroke maintain physically active behaviours in the long-term.
Detailed description
Study Design
This is a 4-week randomized controlled trial consisting of two groups: 1) participants who receive an educational brochure regarding physical activity after stroke, combined with motivational telephone support (intervention group), and 2) participants who receive the educational brochure alone (control group).
Interventions
Participants in the control group will be asked to devote approximately 30 minutes of their time to this study over the course of 4 weeks, and those in the intervention group will be involved for a total of 85 minutes.
- Educational Brochure (both intervention and control groups): The educational brochure, Aerobic Exercise After Stroke, will be provided to all participants in the study. The brochure was created by researchers from the Canadian Partnership for Stroke Recovery and written for a stroke audience. It was designed to educate individuals with stroke about the benefits of aerobic exercise, exercise intensity, and provide a sample program.
- Motivational Telephone Support (intervention group only): Motivational telephone support is an inexpensive way of supplementing the educational brochure for facilitating physical activity behaviors by establishing a personal connection and providing ongoing support and motivation. Participants in the intervention group will receive a total of 4 phone calls that will take place at 1-week intervals. Each telephone session will last approximately 15 minutes, where issues regarding ongoing physical activity, such as relapses and road blocks, will be addressed. Also, ongoing motivation and support will be provided as needed to re-direct participants back onto the path of physical activity engagement.
Statistical Analyses
Baseline participant characteristics will be analyzed using descriptive statistics. A two-way analysis on variance will be used to compare mean differences in physical activity and self-efficacy between the intervention and control group considering a group X time interaction
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brochure and Telephone Support | Experimental | Behavioral: Brochure and Telephone SupportParticipants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls. |
| Brochure Only | Active comparator | Behavioral: BrochureParticipants will receive the Aerobic Exercise After Stroke educational brochure only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completed the intervention arm of a previous trial (Fit for Function)
- Living in the community
- Not involved in active rehabilitation
Key exclusion criteria (3 listed)
- Musculoskeletal contraindications to exercise
- Unstable cardiovascular conditions
- Unstable medical conditions
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 |
|---|---|---|
| Brochure and Telephone SupportParticipants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls. | Behavioural | Brochure and Telephone Support |
| BrochureParticipants will receive both the Aerobic Exercise After Stroke educational brochure. | Behavioural | Brochure Only |
Primary outcome
Physical Activity
Time frame: 4 weeks
Rapid Assessment of Physical Activity questionnaire
1 secondary outcome
Physical Activity Self-Efficacy
Time frame: 4 weeks
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 2017.
- Background: PubMed 24846875Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
- Individual participant dataSharing planned: No. Individual participant data will not be made available.
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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.
Ada Tang, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brochure and Telephone Support and Brochure in people with Stroke, run by McMaster University 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 3 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 2017. 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?
Physical Activity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681393, which also lists 1 linked publication.
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 2017.