Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Charite University, Berlin, Germany7 sites in 1 country200 target enrollmentOctober 2013

ConditionsStroke

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Stroke
Sponsor: Charite University, Berlin, Germany
Enrollment: 200
Locations: 7
Primary Endpoint: Gait speed and Barthel Index (BI) (co-primary endpoint)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to investigate whether a 4-week physical fitness training (target intervention) in stroke patients (subacute stage) increase the walking speed and activities of daily living compared with a control intervention (relaxation exercises). The target or control intervention is performed in addition to standard rehabilitation treatment.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

November 1, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Agnes Flöel

Prof. Dr.

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Patient considered unable to comply with study requirements
•stroke due to intracranial hemorrhage primarily due to bleeding from ruptured aneurysm or arteriovenous malformation
•patients with progressive stroke
•unable to perfom the required exercises due to
•medical problems
•musculo-skeletal problems
•neurological problems
•required help to at least 1 persons to walk before stroke due to neurological or non-neurological co-morbidities
•life expectancy of less than 1 year as determined by responsible physician
•alcohol or drug addiction within the last 6 months

Outcomes

Primary Outcomes

Gait speed and Barthel Index (BI) (co-primary endpoint)

Time Frame: 3 months post stroke vs baseline

comparing gait speed (m/s) and points achieved in BARTHEL Index in aerobic and non-aroebic training group 3 months after stroke vs baseline (before intervention)

Secondary Outcomes

Quality of life (QoL)(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
mood(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
Gait speed and Barthel Index (BI)(directly after intervention; 6 months post stroke; all vs baseline)
motor function(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
cognitive function(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
sleep(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
Assessment of safety(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
mobility(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
Disability(directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline)
Physical fitness(directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline)
Maximal walking speed and Barthel-Index(3 months post stroke vs. baseline)