Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

NCT ID: NCT01953549

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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physical fitness training

aerobic physical fitness training

Group Type EXPERIMENTAL

physical fitness training

Intervention Type PROCEDURE

relaxation

non-aerobic training

Group Type ACTIVE_COMPARATOR

relaxation

Intervention Type PROCEDURE

Interventions

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physical fitness training

Intervention Type PROCEDURE

relaxation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Agnes Flöel

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beelitz Heilstätten

Beelitz-Heilstätten, Brandenburg, Germany

Site Status

Median Klinik Grünheide

Grünheide, Brandenburg, Germany

Site Status

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Charité Campus Benjamin Franklin

Berlin, , Germany

Site Status

Vivantes Klinikum Neukölln

Berlin, , Germany

Site Status

Evanglisches Geriatriezentrum Berlin

Berlin, , Germany

Site Status

Medical Park Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 24491065 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39649709 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34512526 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31533934 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Study Documents

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Document Type: Statistical Analysis Plan

Statistical Analysis Plan of PHYS-Stroke Trial. If download path is offline please contact [email protected]

View Document

Other Identifiers

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PHYS-Stroke

Identifier Type: -

Identifier Source: org_study_id

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