Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
NCT ID: NCT01953549
Last Updated: 2019-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2013-10-31
2017-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Task-specific Training on Physical Activity Levels Post-stroke
NCT02937480
Pre-stroke Physical Activity in Patients With Stroke
NCT05051111
Neuroathletic Training in Stroke Rehabilitation? A Single-blind Randomized Controlled Pilot Study on the Potentials of Neuroathletic Training on Balance Ability in Stroke Outpatient Rehabilitation
NCT06391801
Promoting Physical Activity After Stroke Via Self-management
NCT05461976
Factors Affecting Physical Activity in Stroke
NCT06049069
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
physical fitness training
aerobic physical fitness training
physical fitness training
relaxation
non-aerobic training
relaxation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
physical fitness training
relaxation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Charite University, Berlin, Germany
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Agnes Flöel
Prof. Dr.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beelitz Heilstätten
Beelitz-Heilstätten, Brandenburg, Germany
Median Klinik Grünheide
Grünheide, Brandenburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Charité Campus Benjamin Franklin
Berlin, , Germany
Vivantes Klinikum Neukölln
Berlin, , Germany
Evanglisches Geriatriezentrum Berlin
Berlin, , Germany
Medical Park Berlin
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Rackoll T, Hinrichs T, Neumann K, Wolfarth B, Nave AH; Phys-Stroke Study Group. Improvements in Walking During Subacute Stroke Rehabilitation Translate to Physical Activity at the Chronic Stage: A Sub-Analysis From the Phys Stroke Trial. Brain Neurorehabil. 2024 Oct 28;17(3):e17. doi: 10.12786/bn.2024.17.e17. eCollection 2024 Nov.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Statistical Analysis Plan
Statistical Analysis Plan of PHYS-Stroke Trial. If download path is offline please contact [email protected]
View DocumentOther Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHYS-Stroke
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.