Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Stroke Clinical Trial

Official title:

Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953549
• Other study ID #: PHYS-Stroke
• Status: Completed
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: November 1, 2017

Study information

• Verified date: June 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 1, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• physical fitness training

• relaxation

Locations

Country	Name	City	State
Germany	Beelitz Heilstätten	Beelitz Heilstatten	Brandenburg
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Charité Campus Benjamin Franklin	Berlin
Germany	Evanglisches Geriatriezentrum Berlin	Berlin
Germany	Medical Park Berlin	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Median Klinik Grünheide	Grunheide	Brandenburg

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	resting systolic and diastolic blood pressure	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)	directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline
Other	laboratory parameters	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	hair cortisol concentration	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)	at baseline
Other	resting heart rate	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	waist to hip ratio	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	markers of peripheral immunity	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	lipid profile	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	blood glucose	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	markers of inflammation	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	body mass index	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Other	Endothelial function	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)	directly after intervention vs. baseline
Other	Magnetic resonance imaging parameters	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)	directly after intervention vs. baseline
Primary	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)	3 months post stroke vs baseline
Secondary	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)	directly after intervention; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline
Secondary	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)	directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
Secondary	Maximal walking speed and Barthel-Index	per Protocol analysis of co-primary endpoint (pre-specified in statistical analysis plan and protocol)	3 months post stroke vs. baseline