Recovery Improved in Covert Stroke With Exercise

Cerebral Small Vessel Diseases Clinical Trial

— RISE-2  

Official title:

Achieving Brain Benefits in Covert Stroke Through Aerobic Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068391
• Other study ID #: RISE2-2014-312185
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: September 12, 2018

Study information

• Verified date: September 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 12, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• 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)

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Intervention

Behavioral:
• Stretching 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.
• Exercise Program
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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Toronto Rehabilitation Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in white matter integrity from baseline to 6 months	Diffusion tensor imaging (DTI) MRI	6 months
Other	Change in aerobic fitness from baseline to 6 months	Peak oxygen uptake	6 months
Other	Change in aerobic fitness from 6 to 12 months	Peak oxygen uptake	12 months
Other	Change in autonomic function from baseline to 6 months	Heart rate variability	6 months
Other	Change in autonomic function from 6 to 12 months	Heart rate variability	12 months
Other	Change in arterial stiffness from baseline to 6 months	Carotid-femoral pulse wave velocity	6 months
Other	Change in arterial stiffness from 6 to 12 months	Carotid-femoral pulse wave velocity	12 months
Other	Change in executive function from baseline to 6 months	Trail Making Test	6 months
Other	Change in executive function from 6 to 12 months	Trail Making Test	12 months
Other	Change in balance from baseline to 6 months	Spatial-temporal synchronization of center of pressure	6 months
Other	Change in balance from 6 to 12 months	Spatial-temporal synchronization of center of pressure	12 months
Other	Change in dual task gait from baseline to 6 months	Comparison of normal gait to gait with verbal math challenge	6 months
Other	Change in dual task gait from 6 to 12 months	Comparison of normal gait to gait with verbal math challenge	12 months
Other	Change in grip strength from baseline to 6 months	Maximum grip strength with dynamometer	6 months
Other	Change in grip strength from 6 to 12 months	Maximum grip strength with dynamometer	12 months
Primary	Change in cerebral blood flow from baseline to 6 months	Pseudo-continuous arterial spin labeling MRI	6 months
Primary	Change in brain structure from baseline to 6 months	Cortical and subcortical grey matter density using structural MRI	6 months
Secondary	Change in brain activity related to attention and executive control tasks from baseline to 6 months	Blood oxygenation level dependent MRI	6 months