Recovery Improved in Covert Stroke With Exercise

NCT02068391 | Completed

• 1 other identifier: RISE2-2014-312185
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Small Vessel Diseases

Keywords

covert stroke; cerebral blood flow; grey matter; attention; executive function; aerobic exercise

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

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

  6 months

Other Outcomes (15)

• Change in white matter integrity from baseline to 6 months

  6 months

• Change in aerobic fitness from baseline to 6 months

  6 months

• Change in aerobic fitness from 6 to 12 months

  12 months

Study Arms (2)

Exercise

EXPERIMENTAL

This group will perform the 'Exercise Program' for months 0 to 6, and will be unsupervised for months 7 to 12.

Behavioral: Exercise Program

Stretching

ACTIVE COMPARATOR

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

Interventions

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.

Stretching

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.

Exercise; Stretching

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Toronto Rehabilitation Institute: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bradley MacIntosh, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Imaging Scientist

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: June 1, 2015
• Primary Completion: March 7, 2018
• Study Completion: September 12, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

CA (1)