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| Name | Class |
|---|---|
| Toronto Rehabilitation Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | This group will perform the 'Exercise Program' for months 0 to 6, and will be unsupervised for months 7 to 12. |
|
| Stretching | Active Comparator | This group will perform the 'Stretching Program' for months 0 to 6, and the 'Exercise Program' for months 7 to 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretching Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral blood flow from baseline to 6 months | Pseudo-continuous arterial spin labeling MRI | 6 months |
| Change in brain structure from baseline to 6 months | Cortical and subcortical grey matter density using structural MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain activity related to attention and executive control tasks from baseline to 6 months | Blood oxygenation level dependent MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in white matter integrity from baseline to 6 months | Diffusion tensor imaging (DTI) MRI | 6 months |
| Change in aerobic fitness from baseline to 6 months | Peak oxygen uptake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley MacIntosh, PhD | Sunnybrook Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D059345 | Cerebral Small Vessel Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Exercise Program | Behavioral | 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. |
|
| 6 months |
| Change in aerobic fitness from 6 to 12 months | Peak oxygen uptake | 12 months |
| Change in autonomic function from baseline to 6 months | Heart rate variability | 6 months |
| Change in autonomic function from 6 to 12 months | Heart rate variability | 12 months |
| Change in arterial stiffness from baseline to 6 months | Carotid-femoral pulse wave velocity | 6 months |
| Change in arterial stiffness from 6 to 12 months | Carotid-femoral pulse wave velocity | 12 months |
| Change in executive function from baseline to 6 months | Trail Making Test | 6 months |
| Change in executive function from 6 to 12 months | Trail Making Test | 12 months |
| Change in balance from baseline to 6 months | Spatial-temporal synchronization of center of pressure | 6 months |
| Change in balance from 6 to 12 months | Spatial-temporal synchronization of center of pressure | 12 months |
| Change in dual task gait from baseline to 6 months | Comparison of normal gait to gait with verbal math challenge | 6 months |
| Change in dual task gait from 6 to 12 months | Comparison of normal gait to gait with verbal math challenge | 12 months |
| Change in grip strength from baseline to 6 months | Maximum grip strength with dynamometer | 6 months |
| Change in grip strength from 6 to 12 months | Maximum grip strength with dynamometer | 12 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |