An interventional study of Stretching Program and Exercise Program in Cerebral Small Vessel Diseases, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-18.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Prevention
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.
121 studies on the registry are indexed under Cerebral Small Vessel Diseases; 66 are open to participants now.
This study's enrollment of 39 is below the median of 84 across 69 interventional studies indexed under Cerebral Small Vessel Diseases.
Browse Cerebral Small Vessel Diseases studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
This group will perform the 'Exercise Program' for months 0 to 6, and will be unsupervised for months 7 to 12.
Behavioral: Exercise Program
This group will perform the 'Stretching Program' for months 0 to 6, and the 'Exercise Program' for months 7 to 12.
Behavioral: Stretching Program · Behavioral: Exercise Program
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.
Change in cerebral blood flow from baseline to 6 months
Pseudo-continuous arterial spin labeling MRI
Time frame: 6 months
Change in brain structure from baseline to 6 months
Cortical and subcortical grey matter density using structural MRI
Time frame: 6 months
Change in brain activity related to attention and executive control tasks from baseline to 6 months
Blood oxygenation level dependent MRI
Time frame: 6 months
Change in white matter integrity from baseline to 6 months
Diffusion tensor imaging (DTI) MRI
Time frame: 6 months
Change in aerobic fitness from baseline to 6 months
Peak oxygen uptake
Time frame: 6 months
Change in aerobic fitness from 6 to 12 months
Peak oxygen uptake
Time frame: 12 months
Change in autonomic function from baseline to 6 months
Heart rate variability
Time frame: 6 months
Change in autonomic function from 6 to 12 months
Heart rate variability
Time frame: 12 months
Change in arterial stiffness from baseline to 6 months
Carotid-femoral pulse wave velocity
Time frame: 6 months
Change in arterial stiffness from 6 to 12 months
Carotid-femoral pulse wave velocity
Time frame: 12 months
Change in executive function from baseline to 6 months
Trail Making Test
Time frame: 6 months
Change in executive function from 6 to 12 months
Trail Making Test
Time frame: 12 months
Change in balance from baseline to 6 months
Spatial-temporal synchronization of center of pressure
Time frame: 6 months
Change in balance from 6 to 12 months
Spatial-temporal synchronization of center of pressure
Time frame: 12 months
Change in dual task gait from baseline to 6 months
Comparison of normal gait to gait with verbal math challenge
Time frame: 6 months
Change in dual task gait from 6 to 12 months
Comparison of normal gait to gait with verbal math challenge
Time frame: 12 months
Change in grip strength from baseline to 6 months
Maximum grip strength with dynamometer
Time frame: 6 months
Change in grip strength from 6 to 12 months
Maximum grip strength with dynamometer
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Cerebral Small Vessel Diseases→
Sunnybrook Health Sciences Centre