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physical fitness training, relaxation

Phase 3

Stroke | Unknown | Neurology |Pulmonx Corporation|Last Updated: Jun 6, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

physical fitness training, relaxation · 1 trial · 1 indication

Phase 3 1
NCT01953549Physical Fitness Training in Subacute Stroke (PHYS-Stroke)Stroke
COMPLETED200 Analytics
PHASE3COMPLETED
Physical Fitness Training in Subacute Stroke (PHYS-Stroke)
StrokeUnlock trial analytics

Study Endpoints

Primary Endpoints

Gait speed and Barthel Index (BI) (co-primary endpoint)
3 months post stroke vs baseline

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 Endpoints

Gait speed and Barthel Index (BI)
directly after intervention; 6 months post stroke; all vs baseline
motor function
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
mobility
directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
physical fitness trainingEXPERIMENTALaerobic physical fitness training
relaxationACTIVE_COMPARATORnon-aerobic training

Interventions

NameTypeDescription
physical fitness trainingPROCEDURE -
relaxationPROCEDURE -
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites7

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 pa...

Countries:Germany
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