Cerebral Small Vessel DiseasesRISE-2NCT02068391
Recovery Improved in Covert Stroke With Exercise
A study testing Stretching Program and Exercise Program in people with Cerebral Small Vessel Diseases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Silent ischemic, also known as "covert stroke vascular disease" (CSVD), contributes to neurological deficits that are caused by damage to small blood vessels in the brain. CSVD occurs six to ten times more often that an acute stroke. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- Stretching Program and Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2015to 12 Sep 2018
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Covert stroke: white matter hyperintensities of presumed vascular origin
- Ability to walk for 10 minutes without assistance from another person
- Fluent in English
- Ability to consent
Who cannot join
- Highly fit individuals exercising ≥ 150 minutes per week
- Dementia
- Multiple Sclerosis
- Disabling stroke (ischemic or hemorrhagic)
- Major concurrent illness (e.g. chronic obstructive lung disorder, current or metastatic cancer, chronic kidney disease)
- Major psychiatric illness (e.g. bipolar, schizophrenia, major depression)
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- Contraindications to MRI scanning (e.g. claustrophobia, implants, prostheses, metallic fragments)
- Contraindications to exercise (participants must have medical clearance to exercise from their attending physician)
- Recent change in health status (e.g. hospitalization within past month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Achieving Brain Benefits in Covert Stroke Through Aerobic Exercise
Silent ischemic, also known as "covert stroke vascular disease" (CSVD), contributes to neurological deficits that are caused by damage to small blood vessels in the brain. CSVD occurs six to ten times more often that an acute stroke. It is misleading to think, however, that CSVD is an inevitable part of "getting old" because people with CSVD are at high risk of developing an acute stroke or dementia. In fact, people with more CSVD lesion volume are more likely to develop day to day problems in planning, decision-making and speed of thinking. Unfortunately, there are no proven therapies designed to address CSVD. We propose to test whether aerobic exercise is an intervention that can combat CSVD because the disease is fundamentally a blood flow problem that may be improved by aerobic exercise. We will recruit CSVD adults with moderate to severe lesion burden and use magnetic resonance imaging (MRI) to study the brain in terms of structure, perfusion and function. Participants will be randomly assigned to either our established aerobic exercise program or a control stretching program. Both groups will take part in lab exercise sessions, which are designed to monitor progress and assess adherence to the program. The duration and intensity of their exercise will increase as participants progress. We will use activity log books, phone calls and extra "booster" exercise sessions, as needed, to maximize retention and adherence. We aim to show that aerobic exercise increases cerebral blood flow (CBF) in frontal-subcortical grey matter, supports regional tissue growth, and improves cognitive function in CSVD adults with substantial risk of acute stroke and dementia. A positive outcome of this research will provide strong support for additional clinical trials aimed at sustaining cognition and maintaining independent living.
- Conditions
- Cerebral Small Vessel Diseases
- Being tested
- Stretching Program, Exercise Program
- Keywords
- covert stroke, cerebral blood flow, grey matter, attention, executive function, aerobic exercise
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching ProgramBehavioural
The 'Stretching Program' will teach stretching for the upper and lower limbs, and the trunk, as well as breathing exercises for relaxation. Supervised group activities will be performed once per week (45 minutes) and self-directed stretching will be encouraged 4 days per week and monitored by an activity journal. The intensity of stretching and number of stretches will be progressed every 2 weeks. Heart rate and perceived exertion will be monitored. The program will last 6 months.
Exercise ProgramBehavioural
The 'Exercise Program' will prescribe specific aerobic exercise to the participants. Supervised group exercise will be performed once per week (60 minutes) and self-directed exercise will be encouraged 4 days per week and monitored by an activity journal. The initial walking prescription will be set at ~1.6 km and an intensity equivalent to the anaerobic threshold and/or 60% of peak oxygen uptake. Progressions will be made every 2 weeks, increasing distance to a maximum of 6.4 km and then increasing to a max intensity of 80% of peak oxygen uptake and/or max duration of 60 minutes. Heart rate and perceived exertion will be monitored. The program will last 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | This group will perform the 'Exercise Program' for months 0 to 6, and will be unsupervised for months 7 to 12. Receives: Behavioral: Exercise Program |
| Stretching | Active comparator | This group will perform the 'Stretching Program' for months 0 to 6, and the 'Exercise Program' for months 7 to 12. Receives: Behavioral: Stretching Program; Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow from baseline to 6 months
Pseudo-continuous arterial spin labeling MRI
Measured: 6 months
Change in brain structure from baseline to 6 months
Cortical and subcortical grey matter density using structural MRI
Measured: 6 months
Secondary outcomes (1)
Change in brain activity related to attention and executive control tasks from baseline to 6 months
Blood oxygenation level dependent MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study start1 Jun 2015
- Primary completion7 Mar 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Responsible party
- Principal investigator, Dr. Bradley MacIntosh, Sunnybrook Health Sciences Centre
- Investigators
- Bradley MacIntosh, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068391
- Sponsor's protocol ID
- RISE2-2014-312185
- Acronym
- RISE-2
- Status last verified
- Sep 2018
- First submitted
- 19 Feb 2014
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Brain Benefits in Covert Stroke Through Aerobic Exercise
- ClinicalTrials.gov ID
- NCT02068391
- Acronym / sponsor ID
- RISE-2 / RISE2-2014-312185
- Conditions
- Cerebral Small Vessel Diseases
- Keywords
- covert stroke, cerebral blood flow, grey matter, attention, executive function, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Toronto Rehabilitation Institute
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 21 Feb 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.
Silent ischemic, also known as "covert stroke vascular disease" (CSVD), contributes to neurological deficits that are caused by damage to small blood vessels in the brain. CSVD occurs six to ten times more often that an acute stroke. It is misleading to think, however, that CSVD is an inevitable part of "getting old" because people with CSVD are at high risk of developing an acute stroke or dementia. In fact, people with more CSVD lesion volume are more likely to develop day to day problems in planning, decision-making and speed of thinking. Unfortunately, there are no proven therapies designed to address CSVD. We propose to test whether aerobic exercise is an intervention that can combat CSVD because the disease is fundamentally a blood flow problem that may be improved by aerobic exercise. We will recruit CSVD adults with moderate to severe lesion burden and use magnetic resonance imaging (MRI) to study the brain in terms of structure, perfusion and function. Participants will be randomly assigned to either our established aerobic exercise program or a control stretching program. Both groups will take part in lab exercise sessions, which are designed to monitor progress and assess adherence to the program. The duration and intensity of their exercise will increase as participants progress. We will use activity log books, phone calls and extra "booster" exercise sessions, as needed, to maximize retention and adherence. We aim to show that aerobic exercise increases cerebral blood flow (CBF) in frontal-subcortical grey matter, supports regional tissue growth, and improves cognitive function in CSVD adults with substantial risk of acute stroke and dementia. A positive outcome of this research will provide strong support for additional clinical trials aimed at sustaining cognition and maintaining independent living.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise ProgramThis group will perform the 'Exercise Program' for months 0 to 6, and will be unsupervised for months 7 to 12. |
| Stretching | Active comparator | Behavioral: Stretching Program, Behavioral: Exercise ProgramThis group will perform the 'Stretching Program' for months 0 to 6, and the 'Exercise Program' for months 7 to 12. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Covert stroke: white matter hyperintensities of presumed vascular origin
- Ability to walk for 10 minutes without assistance from another person
- Fluent in English
- Ability to consent
Key exclusion criteria (9 listed)
- Highly fit individuals exercising ≥ 150 minutes per week
- Dementia
- Multiple Sclerosis
- Disabling stroke (ischemic or hemorrhagic)
- Major concurrent illness (e.g. chronic obstructive lung disorder, current or metastatic cancer, chronic kidney disease)
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 |
|---|---|---|
| Stretching ProgramThe 'Stretching Program' will teach stretching for the upper and lower limbs, and the trunk, as well as breathing exercises for relaxation. Supervised group activities will be performed once per week (45 minutes) and self-directed stretching will be encouraged 4 days per week and monitored by an activity journal. The intensity of stretching and number of stretches will be progressed every 2 weeks. Heart rate and perceived exertion will be monitored. The program will last 6 months. | Behavioural | Stretching |
| Exercise ProgramThe 'Exercise Program' will prescribe specific aerobic exercise to the participants. Supervised group exercise will be performed once per week (60 minutes) and self-directed exercise will be encouraged 4 days per week and monitored by an activity journal. The initial walking prescription will be set at ~1.6 km and an intensity equivalent to the anaerobic threshold and/or 60% of peak oxygen uptake. Progressions will be made every 2 weeks, increasing distance to a maximum of 6.4 km and then increasing to a max intensity of 80% of peak oxygen uptake and/or max duration of 60 minutes. Heart rate and perceived exertion will be monitored. The program will last 6 months. | Behavioural | Exercise, Stretching |
Primary outcome
Change in cerebral blood flow from baseline to 6 months
Time frame: 6 months
Pseudo-continuous arterial spin labeling MRI
Change in brain structure from baseline to 6 months
Time frame: 6 months
Cortical and subcortical grey matter density using structural MRI
1 secondary outcome
Change in brain activity related to attention and executive control tasks from baseline to 6 months
Time frame: 6 months
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 18 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
Bradley MacIntosh, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching Program and Exercise Program in people with Cerebral Small Vessel Diseases, run by Sunnybrook Health Sciences Centre 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 4 inclusion and 9 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 18 Sep 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 in cerebral blood flow from baseline to 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. 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 18 Sep 2018.