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StrokePhase 3NCT01953549

Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

A Phase 3 study testing physical fitness training and relaxation in people with Stroke, run by Charite University, Berlin, Germany at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Stroke
What is being tested?
physical fitness training and relaxation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
7 sitesGermany
Study dates
Oct 2013to 1 Nov 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Beelitz Heilstätten

    Beelitz-Heilstätten, Brandenburg, 14547

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Charité Campus Benjamin Franklin

    Berlin, 12200

  • Vivantes Klinikum Neukölln

    Berlin, 12351

  • Evanglisches Geriatriezentrum Berlin

    Berlin, 13347

  • Medical Park Berlin

    Berlin, 13507

  • Median Klinik Grünheide

    Grünheide, Brandenburg, 15537

Other trials in Germany

About this study

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
Being tested
physical fitness training, relaxation
Keywords
physical activity, relaxation, activities of daily living, motor functions, cognitive functions
Medical subject headings
Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physical fitness trainingProcedure or surgery

  • relaxationProcedure or surgery

Study groups in NCT01953549
Study groupRoleWhat they receive
physical fitness trainingExperimentalaerobic physical fitness training
Receives: Procedure: physical fitness training
relaxationActive comparatornon-aerobic training
Receives: Procedure: relaxation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months post stroke vs baseline

Secondary outcomes (11)

  1. Gait speed and Barthel Index (BI)

    comparing gait speed (m/s) and points achieved in BI in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 6 months post stroke vs baseline (before intervention)

    Measured: directly after intervention; 6 months post stroke; all vs baseline

  2. motor function

    comparing motor function (assessed via different clinical scales e.g. Rivermead Arm test, REPAS, Box and Block Test, Medical Research Council Scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  3. mobility

    comparing different mobilitiy indices like gait endurance (in min), stride length, step cadence, use of walking aids, actigraph measurements and the Rivermead mobility Index in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  4. cognitive function

    comparing cognitive function (assessed via points achieved in different scales, e.g. Montreal Cognitive Assessment, Trail Making test, word fluency) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  5. Disability

    comparing disability (Modified rankin scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  6. Quality of life (QoL)

    comparing QoL (EQ-5D-5L scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  7. sleep

    comparing sleep quality (Pittsburgh sleep quality index) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  8. mood

    comparing mood (CES-D scale) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  9. Physical fitness

    comparing gait energy Expenditure in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  10. Assessment of safety

    comparing different criteria (recurrent fatal or non-fatal cardiovascular or cerebrovascular events, refferal to acute hospital, death) in aerobic and non-aroebic training group after the 4-week intervention interval as well as after 3 and after 6 months post stroke vs baseline (before intervention)

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

  11. Maximal walking speed and Barthel-Index

    per Protocol analysis of co-primary endpoint (pre-specified in statistical analysis plan and protocol)

    Measured: 3 months post stroke vs. baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completion6 Jul 2017
  4. Study completion1 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01953549
Sponsor's protocol ID
PHYS-Stroke
Status last verified
Jun 2019
First submitted
28 Jun 2013
Last updated
6 Jun 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24491065

  • Rackoll T, Doppelbauer L, Neumann K, Nave AH. Serum BDNF in subacute stroke: effects of a four-week aerobic exercise intervention in the PHYS-STROKE trial. Front Stroke. 2026 Sep 15;5:1897859. doi: 10.3389/fstro.2026.1897859. eCollection 2026.

    PubMed 42812344

  • Pietrock C, Neumann K, Rentzsch K, Pruss H, Meisel A, Endres M, Nave AH. Neuronal autoantibodies associated with poorer neuropsychological and motor outcomes 6 months after stroke: results from the PHYS-STROKE trial. Front Immunol. 2026 Mar 18;16:1678840. doi: 10.3389/fimmu.2025.1678840. eCollection 2025.

    PubMed 41929475

  • 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.

    PubMed 39649709

  • 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.

    PubMed 34512526

  • 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.

    PubMed 31533934

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing physical fitness training and relaxation in people with Stroke, run by Charite University, Berlin, Germany at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed and Barthel Index (BI) (co-primary endpoint) (time frame: 3 months post stroke vs baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01953549, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.

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