Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 2, 2014
Last verified: June 2014

June 28, 2013
June 2, 2014
October 2013
October 2016   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01953549 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Procedure: physical fitness training
  • Procedure: relaxation
  • Experimental: physical fitness training
    aerobic physical fitness training
    Intervention: Procedure: physical fitness training
  • Active Comparator: relaxation
    non-aerobic training
    Intervention: Procedure: relaxation
Flöel A, Werner C, Grittner U, Hesse S, Jöbges M, Knauss J, Seifert M, Steinhagen-Thiessen E, Gövercin 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
215
March 2017
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Regina Schlieder +49 (0)30 450 560618 regina.schlieder@charite.de
Germany
 
NCT01953549
PHYS-Stroke
Yes
Agnes Flöel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Not Provided
Charite University, Berlin, Germany
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP