Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims
Condition: Cerebrovascular Disorders; Stroke; Prevention
MeSH terms: Stroke; Cerebrovascular Disorders
Study type: Interventional

Summary: 
      Background:

      Stroke represents one of the major health problems worldwide, particularly in transitional
      and industrialized countries. Stroke has a remarkable socioeconomic impact, especially in the
      ageing population, and therefore stroke prevention is important. Secondary preventive
      measures and rehabilitation are essential for reduction of recurrent events. However, to date
      appropriate secondary preventive programs for patients surviving a stroke with minor or no
      residual deficits have been poorly studied.

      Specific aims/projects:

      The aim of this study is to validate the effects of an outpatient secondary prevention
      program on vascular risk factors, adherence to vascular-protective medication, exercise
      capacity and health related quality of life.

      Working Hypothesis:

      The outpatient rehabilitation program results in a significant short (3 months) and long-term
      (1 year) improvement of vascular risk factors, neurological functions, exercise capacity,
      adherence to vasoprotective medication and health related quality of life.

      Experimental design/Methods:

      This is a prospective, randomized clinical trial. At least 100 patients will be randomized
      either to the interventional group or to a group which is treated only by the family
      physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary
      outcome is the number of reached cardiovascular health goals (6 metrics) between the
      interventional group and the group which is treated only by the family physician.

      Expected value of the proposed project:

      The study has the potential to show that an outpatient rehabilitation program significantly
      improves vascular risk factors, adherence to medication, enhances quality of life and
      eventually reduces recurrent strokes and other vascular events. If this is confirmed,
      introducing outpatient rehabilitation programs will have a major socioeconomic impact.
    

Detailed description: 
      Background

      Stroke represents one of the major health problems worldwide, particularly in transitional
      and industrialized countries. Stroke ranks first as cause of handicap in adults, second as
      cause of dementia, third as cause of death and is a frequent cause of epilepsy, depression,
      falls and acute hospital admissions. Stroke has a remarkable socioeconomic impact, especially
      in the ageing population, and therefore stroke prevention is important.

      Stroke begets stroke. Persons who have suffered a stroke are at high risk of suffering
      additional strokes. Therefore, prevention in these persons should be part of their medical
      management. However, secondary stroke prevention is complex due to the numerous risk factors
      and includes pharmacological interventions and non-pharmacological means for risk factor
      reduction. Up to 90% of the stroke risk is attributable to vascular risk factors. Therefore,
      appropriate use of all proven measures of risk factor reduction could prevent up to 90% of
      all strokes. This includes smoking cessation, control of hypertension and diabetes,
      anticoagulants or antiplatelet agents and lipid lowering drugs, a healthy lifestyle with
      regular physical activity, healthy normocaloric diet, moderate or no alcohol consumption,
      low-normal body weight and avoidance of distress. Importantly, effective stroke prevention
      can only be achieved by the reduction of several or all vascular risk factors.

      Secondary preventive measures and rehabilitation are essential for reduction of recurrent
      events. Furthermore, moderate to severely handicapped patients should receive in- and
      outpatient rehabilitation adapted to their individual deficits. The concept of secondary
      prevention through cardiac rehabilitation is an accepted treatment modality in patients after
      myocardial infarction or aortocoronary bypass surgery. However, appropriate secondary
      preventive programs for patients surviving a stroke with minor or no residual deficits are
      lacking. Therefore, the investigators developed a structured 12 week hospital based
      out-patient program for stroke patients with minor or no residual deficits based on the
      already existing format of cardiac rehabilitation to optimize secondary stroke prevention,
      relieve symptoms, improve neurological functioning, and improve health related quality of
      life.

      In a prospective interventional single center cohort pilot study with 105 patients (that is
      submitted for publication), the investigators showed that a 12 week outpatient rehabilitation
      program resulted in a considerable improvement of vascular risk factors, neurological
      functions, and enhanced health related quality of life (see attached abstract).

      The aim of this additional study is to validate the effects of this outpatient program in a
      prospective, randomized clinical trial with crossover design.

      Objective

      The aim of this study is to validate the effects of an outpatient secondary prevention
      program on vascular risk factors, adherence to vascular-protective medication, exercise
      capacity and health related quality of life.

      Methods

      This is a prospective, randomized clinical trial. At least 100 patients with minor stroke or
      transient ischemic attack treated in the University Hospital of Bern will be randomized
      either to the interventional group or to a group which is treated only by the family
      physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary
      outcome is the number of reached cardiovascular health goals (6 metrics: smoking, physical
      exercise capacity, Mediterranean diet compliance, LDL-Cholesterol, Blood pressure, fasting
      plasma glucose) between the interventional group and the group which is treated only by the
      family physician. After inclusion of 100 patients in the study, a study independent
      statistician will perform a power analysis and the final number of patients to be included
      will be adapted.
    

Intervention name(s): Outpatient secondary prevention program; Standard treatment by family physician
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The comprehensive outpatient program is designed to last for 12 weeks. Participants are treated in groups of 8 or less. Every week there are two days with therapeutic and educational sessions, once with two hours of physical exercise therapy and once with 45 minutes of aerobic ergometer training and one hour of lecture and counseling. On the day with the two hours of physical therapy one of the sessions includes aerobic ergometer training or Nordic walking, and the other session focuses on improvements of fine motor skills, coordination, balance, mobilization, stretching, weight training or breathing. The lectures include three lectures on etiology, diagnosis, treatment and prevention of stroke by a neurologist, one on vascular risk factors by a cardiologist, five on nutrition counseling by nutritionists, two on active and passive smoking cessation and one lecture on psychological coping strategies given by a neuropsychologist.; Standard treatment by family physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment