Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

NCT01953549 | Completed Phase 3 DMC

• 1 other identifier: PHYS-Stroke
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Stroke

Keywords

physical activity, relaxation, activities of daily living, motor functions, cognitive functions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• cognitive function

  directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline

• Disability

  directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline

Other Outcomes (12)

• resting systolic and diastolic blood pressure

  directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline

• laboratory parameters

  directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline

• hair cortisol concentration

  at baseline

Study Arms (2)

physical fitness training

EXPERIMENTAL

aerobic physical fitness training

Procedure: physical fitness training

relaxation

ACTIVE COMPARATOR

non-aerobic training

Procedure: relaxation

Interventions

physical fitness training PROCEDURE

physical fitness training

relaxation PROCEDURE

relaxation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of stroke within 5-45 days after stroke
• age \>= 18 years
• able to sit for at least 30 seconds
• considered able to perform aerobic exercise as determined by responsible physician
• Written informed consent of the patient

You may not qualify if:

• 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
• medical problems
• musculo-skeletal problems
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (7)

Beelitz Heilstätten

Beelitz-Heilstätten, Brandenburg, 14547, Germany

Location

Median Klinik Grünheide

Grünheide, Brandenburg, 15537, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Charité Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Evanglisches Geriatriezentrum Berlin

Berlin, 13347, Germany

Location

Medical Park Berlin

Berlin, 13507, Germany

Location

Related Publications (4)

• 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.

  PMID: 24491065 BACKGROUND

• 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.

  PMID: 39649709 DERIVED

• 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.

  PMID: 34512526 DERIVED

• 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.

  PMID: 31533934 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: October 1, 2013
• Study Start: October 1, 2013
• Primary Completion: July 6, 2017
• Study Completion: November 1, 2017
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

DE (7)