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Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
physical fitness training
relaxation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring physical activity, relaxation, activities of daily living, motor functions, cognitive functions

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beelitz Heilstätten
  • Median Klinik Grünheide
  • Charité - Universitätsmedizin Berlin
  • Charité Campus Benjamin Franklin
  • Vivantes Klinikum Neukölln
  • Evanglisches Geriatriezentrum Berlin
  • Medical Park Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

physical fitness training

relaxation

Arm Description

aerobic physical fitness training

non-aerobic training

Outcomes

Primary Outcome Measures

Gait speed and Barthel Index (BI) (co-primary endpoint)
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)
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
comparing motor function (assessed via different clinical scales e.g. Rivermead Arm test, REPAS, Box and Block Test, Medical Research Council 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)
mobility
comparing different mobilitiy indices like gait endurance (in min), stride length, step cadence, use of walking aids, 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
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
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)
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
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
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
comparing 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)
Assessment of safety
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)
Maximal walking speed and Barthel-Index
per Protocol analysis of co-primary endpoint (pre-specified in statistical analysis plan and protocol)

Full Information

First Posted
June 28, 2013
Last Updated
June 4, 2019
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01953549
Brief Title
Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Official Title
Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
physical activity, relaxation, activities of daily living, motor functions, cognitive functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical fitness training
Arm Type
Experimental
Arm Description
aerobic physical fitness training
Arm Title
relaxation
Arm Type
Active Comparator
Arm Description
non-aerobic training
Intervention Type
Procedure
Intervention Name(s)
physical fitness training
Intervention Type
Procedure
Intervention Name(s)
relaxation
Primary Outcome Measure Information:
Title
Gait speed and Barthel Index (BI) (co-primary endpoint)
Description
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)
Time Frame
3 months post stroke vs baseline
Secondary Outcome Measure Information:
Title
Gait speed and Barthel Index (BI)
Description
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)
Time Frame
directly after intervention; 6 months post stroke; all vs baseline
Title
motor function
Description
comparing motor function (assessed via different clinical scales e.g. Rivermead Arm test, REPAS, Box and Block Test, Medical Research Council 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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
mobility
Description
comparing different mobilitiy indices like gait endurance (in min), stride length, step cadence, use of walking aids, 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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
cognitive function
Description
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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
Disability
Description
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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
Quality of life (QoL)
Description
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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
sleep
Description
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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
mood
Description
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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
Physical fitness
Description
comparing 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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline
Title
Assessment of safety
Description
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)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
Maximal walking speed and Barthel-Index
Description
per Protocol analysis of co-primary endpoint (pre-specified in statistical analysis plan and protocol)
Time Frame
3 months post stroke vs. baseline
Other Pre-specified Outcome Measures:
Title
resting systolic and diastolic blood pressure
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline
Title
laboratory parameters
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
hair cortisol concentration
Description
hair cortisol concentration by taking a small strand of hair is measured at baseline; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
at baseline
Title
resting heart rate
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
waist to hip ratio
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
markers of peripheral immunity
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
lipid profile
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
blood glucose
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
markers of inflammation
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
body mass index
Description
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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Title
Endothelial function
Description
the endothelial function of included patients will be assessed prospectively before and after the 4 week intervention with the Endopat2000 device. First measurement was conducted in January 11th 2014. Results will be correlated with imaging and blood-derived biomarkers as well as differences between intervention groups; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention vs. baseline
Title
Magnetic resonance imaging parameters
Description
Primary and secondary endpoints are specified after completion of the interim analysis after inclusion of the first 24 patients (first stage). In a second stage the study is conducted with specified primary and secondary endpoints with recruitment of up to 76 remaining patients; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)
Time Frame
directly after intervention vs. baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 significant current psychiatric illness as defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality current participation in another intervention study
Facility Information:
Facility Name
Beelitz Heilstätten
City
Beelitz Heilstatten
State/Province
Brandenburg
ZIP/Postal Code
14547
Country
Germany
Facility Name
Median Klinik Grünheide
City
Grunheide
State/Province
Brandenburg
ZIP/Postal Code
15537
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Vivantes Klinikum Neukölln
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Evanglisches Geriatriezentrum Berlin
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Medical Park Berlin
City
Berlin
ZIP/Postal Code
13507
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24491065
Citation
Floel A, Werner C, Grittner U, Hesse S, Jobges M, Knauss J, Seifert M, Steinhagen-Thiessen E, Govercin M, Dohle C, Fischer W, Schlieder R, Nave AH, Meisel A, Ebinger M, Wellwood I. Physical fitness training in Subacute Stroke (PHYS-STROKE)--study protocol for a randomised controlled trial. Trials. 2014 Feb 3;15:45. doi: 10.1186/1745-6215-15-45.
Results Reference
background
PubMed Identifier
34512526
Citation
Kirzinger B, Stroux A, Rackoll T, Endres M, Floel A, Ebinger M, Nave AH. Elevated Serum Inflammatory Markers in Subacute Stroke Are Associated With Clinical Outcome but Not Modified by Aerobic Fitness Training: Results of the Randomized Controlled PHYS-STROKE Trial. Front Neurol. 2021 Aug 26;12:713018. doi: 10.3389/fneur.2021.713018. eCollection 2021.
Results Reference
derived
PubMed Identifier
31533934
Citation
Nave AH, Rackoll T, Grittner U, Blasing H, Gorsler A, Nabavi DG, Audebert HJ, Klostermann F, Muller-Werdan U, Steinhagen-Thiessen E, Meisel A, Endres M, Hesse S, Ebinger M, Floel A. Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial. BMJ. 2019 Sep 18;366:l5101. doi: 10.1136/bmj.l5101.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://doi.org/10.6084/m9.figshare.5375026.v1
Available IPD/Information Comments
Statistical Analysis Plan of PHYS-Stroke Trial. If download path is offline please contact torsten.rackoll@charite.de

Learn more about this trial

Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

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