Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial): a multi-centred, randomised controlled trial

Abstract

BackgroundDespite lack of outward signs, most individuals after non-disabling stroke (NDS) and transient ischemic attack (TIA) have significant cardiovascular and cerebrovascular disease and are at high risk of a major stroke, hospitalization for other vascular events, or death. Most have multiple modifiable risk factors (e.g., hypertension, physical inactivity, hyperlipidaemia, diabetes, tobacco consumption, psychological stress). In addition, accelerated rates of depression, cognitive decline, and poor quality of sleep have been reported following TIA, which correlate with poor functional outcomes and reduced quality of life. Thus, NSD and TIA are important warning signs that should not be overlooked. The challenge is not unlike that facing other 'silent' conditions - to identify a model of care that is effective in changing people's current behaviors in order to avert further morbidity.Methods/DesignA single blind, randomized controlled trial will be conducted at two sites to compare the effectiveness of a program of rehabilitative exercise and education versus usual care in modifying vascular risk factors in adults after NDS/TIA. 250 adults within 90 days of being diagnosed with NDS/TIA will be randomly allocated to a 12-week program of exercise and education (PREVENT) or to an outpatient clinic assessment and discussion of secondary prevention recommendations with return clinic visits as indicated (USUAL CARE). Primary outcome measures will include blood pressure, waist circumference, 12-hour fasting lipid profile, and 12-hour fasting glucose/hemoglobin A1c. Secondary measures will include exercise capacity, walking endurance, physical activity, cognitive function, depression, goal attainment and health-related quality of life. Outcome assessment will be conducted at baseline, post-intervention, and 6- and 12-month follow-ups. Direct health care costs incurred over one year by PREVENT versus USUAL CARE participants will also be compared. Ethical approval for the trial has been obtained from the relevant Human Research Ethics Boards.DiscussionWhether timely delivery of an adapted cardiac rehabilitation model is effective in attaining and maintaining vascular risk reduction targets in adults after NDS/TIA is not yet known. We anticipate that the findings of this trial will make a meaningful contribution to the knowledge base regarding secondary stroke prevention.Trial registrationThis trial is registered with the Clinical Trials.gov Registry (NCT00885456).

Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack

“…210,211 Several studies have shown that aerobic exercise and strength training will improve cardiovascular fitness after stroke. 197,[210][211][212][213][214][215] Structured programs of therapeutic exercise have been shown to improve mobility, balance, and endurance, 213 and beneficial effects have been demonstrated in different ethnic groups and in both older and younger patients. 216 Together, these studies provide important information on the safety and selected clinical benefits of exercise after stroke.…”

Physical Activity and Exercise Recommendations for Stroke Survivors

“…68,208 Larger clinical trials are currently under way to examine whether similar models of care involving exercise and risk factor modification can be adapted and implemented among individuals with TIA or a broader range of clinical presentation after stroke. 209,210 These trials represent important steps toward the development of optimal secondary prevention strategies that integrate exercise interventions into a comprehensive risk-reduction program for stroke survivors.…”

Comprehensive Cardiac Rehabilitation for Secondary Prevention After Transient Ischemic Attack or Mild Stroke

“…Protocols for CCR after TIA/mild stroke have been published. 13,14 However, to our knowledge, there has been no previous prospective investigation of CCR early after TIA/MNDS. We hypothesized that an existing 6-month CCR program, in collaboration with a stroke prevention clinic (SPC), could provide feasible, effective secondary prevention following TIA/MNDS, without duplication of infrastructure and expertise.…”