Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims
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|ClinicalTrials.gov Identifier: NCT01924247|
Recruitment Status : Recruiting
First Posted : August 16, 2013
Last Update Posted : June 16, 2017
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.
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Disorders Stroke Prevention||Behavioral: Outpatient secondary prevention program Behavioral: Standard treatment by family physician||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prospective Randomized Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims With Minor or no Residual Deficits|
|Actual Study Start Date :||November 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
Control Arm: Standard treatment by family physician
Behavioral: Standard treatment by family physician
Standard treatment by family physician.
- 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 ]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 interventional arm and the control arm.
- Comparison of neurological function [ Time Frame: 3 months ]NIHSS, mRS, 9-Hole-Peg-Test, Functional gait assessment
- Comparison of inflammation marker [ Time Frame: at 3 months ]C-reactive protein (CRP)
- Comparison of adherence to prescribed medication [ Time Frame: 3 months ]
- Rate of new diagnosed overseen neurological deficits [ Time Frame: 3 months ]
- Comparison of quality-of-life questionnaires [ Time Frame: 3 months ]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 between the interventional arm and the control arm [ Time Frame: at 3 months, at 12 months ]
- Comparison of drop-out rate between the interventional arm and the control arm [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924247
|Department of Neurology, Bern University Hospital||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Simon Jung 0041799357220 firstname.lastname@example.org|
|Contact: Jean-Paul Schmid 0041-31-632 89 72 email@example.com|
|Principal Investigator: Simon Jung|
|Sub-Investigator: Hugo Saner|
|Sub-Investigator: Jean-Paul Schmid|
|Sub-Investigator: Heinrich P Mattle|
|Sub-Investigator: Matthias Wilhelm|
|Principal Investigator:||Simon Jung, MD||Department of Neurology, University Hospital of Bern, 3010 Bern, Switzerland|