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Completed

NCT Number: NCT02068391

Recovery Improved in Covert Stroke With 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.

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in cerebral blood flow from baseline to 6 months

    Time frame: 6 months

    Pseudo-continuous arterial spin labeling MRI

  2. Change in brain structure from baseline to 6 months

    Time frame: 6 months

    Cortical and subcortical grey matter density using structural MRI

Secondary outcomes

  1. Change in brain activity related to attention and executive control tasks from baseline to 6 months

    Time frame: 6 months

    Blood oxygenation level dependent MRI

Other outcomes

  1. Change in white matter integrity from baseline to 6 months

    Time frame: 6 months

    Diffusion tensor imaging (DTI) MRI

  2. Change in aerobic fitness from baseline to 6 months

    Time frame: 6 months

    Peak oxygen uptake

  3. Change in aerobic fitness from 6 to 12 months

    Time frame: 12 months

    Peak oxygen uptake

  4. Change in autonomic function from baseline to 6 months

    Time frame: 6 months

    Heart rate variability

  5. Change in autonomic function from 6 to 12 months

    Time frame: 12 months

    Heart rate variability

  6. Change in arterial stiffness from baseline to 6 months

    Time frame: 6 months

    Carotid-femoral pulse wave velocity

  7. Change in arterial stiffness from 6 to 12 months

    Time frame: 12 months

    Carotid-femoral pulse wave velocity

  8. Change in executive function from baseline to 6 months

    Time frame: 6 months

    Trail Making Test

  9. Change in executive function from 6 to 12 months

    Time frame: 12 months

    Trail Making Test

  10. Change in balance from baseline to 6 months

    Time frame: 6 months

    Spatial-temporal synchronization of center of pressure

  11. Change in balance from 6 to 12 months

    Time frame: 12 months

    Spatial-temporal synchronization of center of pressure

  12. Change in dual task gait from baseline to 6 months

    Time frame: 6 months

    Comparison of normal gait to gait with verbal math challenge

  13. Change in dual task gait from 6 to 12 months

    Time frame: 12 months

    Comparison of normal gait to gait with verbal math challenge

  14. Change in grip strength from baseline to 6 months

    Time frame: 6 months

    Maximum grip strength with dynamometer

  15. Change in grip strength from 6 to 12 months

    Time frame: 12 months

    Maximum grip strength with dynamometer

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Toronto Rehabilitation Institute

Registry information

Official study title

Achieving Brain Benefits in Covert Stroke Through Aerobic Exercise

Acronym: RISE-2

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 21, 2014
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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