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Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

This study is currently recruiting participants.
Verified October 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01953549
First received: June 28, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Stroke
Procedure: physical fitness training
Procedure: relaxation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Gait speed and Barthel Index (BI) (co-primary endpoint) [ Time Frame: 3 months post stroke vs baseline ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Gait speed and Barthel Index (BI) [ Time Frame: directly after intervention; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing gait speed (m/s) and points achieved in BI in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 6 months post stroke vs baseline (before intervention)

  • motor function [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing motor function (assessed via different clinical scales e.g. Rivermead Arm test, REPAS) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • mobility [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing different mobilitiy indices like gait endurance (in min), actigraph measurements and the Rivermead mobility Index in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • cognitive function [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing cognitive function (assessed via points achieved in different scales, e.g. Montreal Cognitive Assessment, Trail Making test, word fluency) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • Disability [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing disability (Modified rankin scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • Quality of life (QoL) [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing QoL (EQ-5D-5L scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • sleep [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing sleep quality (Pittsburgh sleep quality index) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • mood [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing mood (CES-D scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • Physical fitness [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline ] [ Designated as safety issue: No ]
    comparing VO2 max and gait energy Expenditure in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • resting systolic and diastolic blood pressure [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline ] [ Designated as safety issue: No ]
    comparing resting systolic and diastolic blood pressure (mmHg) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • laboratory parameters [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing different laboratory parameters (derived by blood draw) like hormones, hemogram, liver and kidney function, and coagulation parameters in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • hair cortisol concentration [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    hair cortisol concentration by taking a small strand of hair is measured at baseline

  • Assessment of safety [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: Yes ]
    comparing different criteria (recurrent fatal or non-fatal cardiovascular or cerebrovascular events, refferal to acute hospital, death) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • resting heart rate [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comaparing resting heart rate(beats/minute) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • body mass index [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing body mass index in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • waist to hip ratio [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing waist to hip ratio (cm) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • markers of inflammation [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing markers of inflammation (e.g., including Interleukin (IL) 6, 1b, hs-CRP) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • markers of peripheral immunity [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comapring markers of peripheral immunity (e.g., monocytic HLA-DR expression) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • blood glucose [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing insulin, glucose, and HbA1c in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

  • lipid profile [ Time Frame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline ] [ Designated as safety issue: No ]
    comparing lipide such as triglycerides, cholesterol (total, LDL,HDL, and LP(a)) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)


Estimated Enrollment: 215
Study Start Date: October 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: physical fitness training
aerobic physical fitness training
Procedure: physical fitness training
Active Comparator: relaxation
non-aerobic training
Procedure: relaxation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for patients:

  • diagnosis of stroke within 5-45 days after stroke
  • age >= 18 years
  • able to sit for at least 30 seconds
  • Barthel index < =65 at inclusion
  • considered able to perform aerobic exercise as determined by responsible physician
  • Written informed consent of the patient

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

    1. medical problems
    2. musculo-skeletal problems
    3. 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
  • significant current psychiatric illness as defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality
  • current participation in another intervention study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953549

Contacts
Contact: Regina Schlieder +49 (0)30 450 560618 regina.schlieder@charite.de

Locations
Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Agnes Flöel, Prof. Dr.    0049 30 450 560284    agnes.floeel@charite.de   
Principal Investigator: Agnes Flöel, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01953549     History of Changes
Other Study ID Numbers: PHYS-Stroke
Study First Received: June 28, 2013
Last Updated: October 18, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
physical activity, relaxation, activities of daily living, motor functions, cognitive functions

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

ClinicalTrials.gov processed this record on April 15, 2014