Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
NCT Number: NCT02068391
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.
Looking for future studies?
Notify Me55 year–80 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M4N 3M5, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months
Pseudo-continuous arterial spin labeling MRI
Time frame: 6 months
Cortical and subcortical grey matter density using structural MRI
Time frame: 6 months
Blood oxygenation level dependent MRI
Time frame: 6 months
Diffusion tensor imaging (DTI) MRI
Time frame: 6 months
Peak oxygen uptake
Time frame: 12 months
Peak oxygen uptake
Time frame: 6 months
Heart rate variability
Time frame: 12 months
Heart rate variability
Time frame: 6 months
Carotid-femoral pulse wave velocity
Time frame: 12 months
Carotid-femoral pulse wave velocity
Time frame: 6 months
Trail Making Test
Time frame: 12 months
Trail Making Test
Time frame: 6 months
Spatial-temporal synchronization of center of pressure
Time frame: 12 months
Spatial-temporal synchronization of center of pressure
Time frame: 6 months
Comparison of normal gait to gait with verbal math challenge
Time frame: 12 months
Comparison of normal gait to gait with verbal math challenge
Time frame: 6 months
Maximum grip strength with dynamometer
Time frame: 12 months
Maximum grip strength with dynamometer
Sunnybrook Health Sciences Centre
Other
Achieving Brain Benefits in Covert Stroke Through Aerobic Exercise
Acronym: RISE-2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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