Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Schweizerische Herzstiftung
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01924247
First received: August 9, 2013
Last updated: November 12, 2015
Last verified: November 2015
  Purpose

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 a group that starts the rehabilitation program immediately after the stroke or with a delay of 3 months. 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 immediate and the delayed program start group at 3 months.

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.


Condition Intervention
Cerebrovascular Disorders
Stroke
Prevention
Behavioral: Outpatient secondary prevention program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims With Minor or no Residual Deficits

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Improvement of a combined endpoint of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary endpoint is a combined endpoint of improvement of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status between the immediate and the delayed program start group at 3 months.


Secondary Outcome Measures:
  • Comparison of neurological function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    NIHSS, mRS, 9-Hole-Peg-Test, Functional gait assessment

  • Comparison of inflammation marker [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    C-reactive protein (CRP)

  • Comparison of adherence to prescribed medication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Rate of new diagnosed overseen neurological deficits [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Comparison of quality-of-life questionnaires [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    SF 36, DS 14, HADS, Jenkins 4-Items Quest, Fatigue Skala für Motorik und Kognition, EUROQUAL, Stroke Specific Quality of Life, PH Q-9, WHOQQL Bref, Mediterranean Diet Compliance Questionnaire, SWISSPAQ

  • Comparison of the primary outcome measures in the immediate start group at 12 months compared to 3 months [ Time Frame: at 3 months, at 12 months ] [ Designated as safety issue: No ]
  • Comparison of drop-out rate between the delayed start group and the immediate start group [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Immediate Treatment
immediate treatment
Behavioral: Outpatient secondary prevention program
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.
Delayed Treatment
delayed (3 months) treatment
Behavioral: Outpatient secondary prevention program
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ischemic stroke and TIA
  • Inclusion in the first 60 days after stroke
  • Age between 18 and 75 years
  • Minor or no residual neurological deficits (mRS 0-1)
  • Written consent by the patient

Exclusion Criteria

  • Severe congestive heart failure (NYHA IV)
  • Evidence of disabling stroke or dementia as measured by modified Rankin Scale score of ≥3 or a MOCA score < 26
  • Any medical condition which disables a patient to participate physical exercise training
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924247

Locations
Switzerland
Department of Neurology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Schweizerische Herzstiftung
Investigators
Principal Investigator: Simon Jung, MD Department of Neurology, University Hospital of Bern, 3010 Bern, Switzerland
  More Information

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01924247     History of Changes
Other Study ID Numbers: 090/13 
Study First Received: August 9, 2013
Last Updated: November 12, 2015
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2016