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

NCT01924247 | Completed DMC

• 1 other identifier: 090/13
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebrovascular Disorders; Stroke; Prevention

Outcome Measures

Primary Outcomes (1)

• Improvement of a combined endpoint of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status

  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.

  3 months

Secondary Outcomes (7)

• Comparison of neurological function

  3 months

• Comparison of inflammation marker

  at 3 months

• Comparison of adherence to prescribed medication

  3 months

• Rate of new diagnosed overseen neurological deficits

  3 months

• Comparison of quality-of-life questionnaires

  3 months

Study Arms (2)

Interventional Arm

OTHER

Interventional Arm

Behavioral: Outpatient secondary prevention program

Control Arm

OTHER

Control Arm: Standard treatment by family physician

Behavioral: Standard treatment by family physician

Interventions

Outpatient secondary prevention program BEHAVIORAL

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.

Interventional Arm

Standard treatment by family physician BEHAVIORAL

Standard treatment by family physician.

Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Schweizerische Herzstiftung: collaborator

Study Sites (1)

Department of Neurology, Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simon Jung, MD

  Department of Neurology, University Hospital of Bern, 3010 Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 16, 2013
• Study Start: November 1, 2013
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CH (1)