Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial): A Randomized Controlled Trial.

BACKGROUND: Non-disabling stroke (NDS) and transient ischemic attack (TIA) herald the possibility of future, more debilitating vascular events. Evidence is conflicting about potency of exercise and education in reducing risk factors for second stroke. METHODS: Three-site, single-blinded, randomized controlled trial with 184 participants <3 months of NDS or TIA (mean age, 65 years; 66% male) randomized to usual care (UC) or UC + 12-week program of exercise and education (PREVENT). Primary (resting systolic blood pressure) and secondary outcomes (diastolic blood pressure [DBPrest], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], total cholesterol [TC], TC/HDL, triglycerides, fasting glucose, and body mass index) were assessed at baseline, post-intervention, and 6- and 12-month follow-up. Peak oxygen consumption (VO2peak) was measured at baseline, post-intervention, 12-month assessments. RESULTS: Significant between-group differences at post-intervention favored PREVENT group over UC: DBPrest (mean difference [MD]: -3.2 mmHg, 95% confidence interval [CI]: -6.3, -.2, P = .04) and LDL-C (MD: -.31 mmol/L, 95% CI: -.42, -.20, P = .02). Trends of improvement in PREVENT group were noted in several variables between baseline and 6-month follow-up but not sustained at 12-month follow-up. Of note, VO2 peak did not change over time in either group. CONCLUSION: Impact of PREVENT on vascular risk factor reduction was more modest than anticipated, possibly because several outcome variables approximated normative values at baseline and training intensity may have been sub-optimal. Further investigation is warranted to determine when exercise and education programs are viable adjuncts to pharmaceutical management for reduction of risk factors for second stroke.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: #NCT00885456.

Primary Prevention of Sudden Cardiac Death With Device Therapy in Urban and Rural Populations.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) have shown benefit in reducing mortality in patients with heart failure, after myocardial infarction, and those with reduced ejection fraction. We sought to explore the use of this therapy in specialized heart function clinics, in rural and urban locations. METHODS: This was a retrospective cohort study performed in 3 specialized heart function clinics in Nova Scotia, 2 of which were in rural locations. All patients with an initial left ventricular ejection fraction ≤ 35% were included from 2006 to 2011. Rates of referral, ICD implantation, and mortality were compared between urban and rural groups. RESULTS: There were 922 patients included in the study; 636 patients in the urban clinic, 286 in the rural locations. Referral rates were higher in the urban clinic compared with the rural locations (80.4% vs 68.3%; P = 0.024). Refusal rates for referral were higher in the rural locations (13.7% vs 2.1%; P < 0.0001). Higher referral rates were associated with urban location (odds ratio [OR], 1.81; 95% confidence interval [CI], 1.01-3.26; P = 0.047), and younger age (OR, 0.96; 95% CI, 0.93-0.99; P = 0.003); lower referral rates for women was observed (OR, 2.29; 95% CI, 1.13-4.63; P = 0.021). Mortality was significantly associated with older age, lack of referral, presence of comorbidities (renal failure, diabetes, peripheral vascular disease) and a rural location. CONCLUSIONS: Specialized heart function clinics have a high rate of appropriate referral for primary prevention ICDs, but referral rates for this life-saving therapy remain lower in rural jurisdictions. This disparity in access to care is associated with increased mortality and might require particular attention to prevent unnecessary deaths.

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.

BACKGROUND: Despite 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/DESIGN: A 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. DISCUSSION: Whether 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.