Clinical trial NCT01953549: Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Official title: Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: physical activity, relaxation, activities of daily living, motor functions, cognitive functions
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

  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

Primary outcomes:
measure: Gait speed and Barthel Index (BI) (co-primary endpoint)
timeFrame: 3 months post stroke vs baseline
Secondary outcomes:
measure: Gait speed and Barthel Index (BI)
timeFrame: directly after intervention; 6 months post stroke; all vs baseline
measure: motor function
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: mobility
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: cognitive function
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: Disability
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: Quality of life (QoL)
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: sleep
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: mood
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: Physical fitness
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline
measure: Assessment of safety
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: Maximal walking speed and Barthel-Index
timeFrame: 3 months post stroke vs. baseline
Other outcomes:
measure: resting systolic and diastolic blood pressure
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline
measure: laboratory parameters
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: hair cortisol concentration
timeFrame: at baseline
measure: resting heart rate
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: waist to hip ratio
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: markers of peripheral immunity
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: lipid profile
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: blood glucose
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: markers of inflammation
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: body mass index
timeFrame: directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
measure: Endothelial function
timeFrame: directly after intervention vs. baseline
measure: Magnetic resonance imaging parameters
timeFrame: directly after intervention vs. baseline
Locations:
city: Beelitz Heilstatten
country: Germany
facility: Beelitz Heilstätten
state: Brandenburg
city: Grunheide
country: Germany
facility: Median Klinik Grünheide
state: Brandenburg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Evanglisches Geriatriezentrum Berlin
city: Berlin
country: Germany
facility: Medical Park Berlin
Study officials:
References:
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.
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.
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.