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Completed

NCT Number: NCT01953549

Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beelitz Heilstätten, Beelitz-Heilstätten, Brandenburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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
  • 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

Treatment and study plan

physical fitness training

Procedure

relaxation

Procedure

Primary outcomes

  1. Gait speed and Barthel Index (BI) (co-primary endpoint)

    Time frame: 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 outcomes

  1. Gait speed and Barthel Index (BI)

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

    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)

  2. motor function

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

    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)

  3. mobility

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

    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)

  4. cognitive function

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

    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)

  5. Disability

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

    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)

  6. Quality of life (QoL)

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

    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)

  7. sleep

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

    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)

  8. mood

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

    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)

  9. Physical fitness

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

    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)

  10. Assessment of safety

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

    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)

  11. Maximal walking speed and Barthel-Index

    Time frame: 3 months post stroke vs. baseline

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

Other outcomes

  1. resting systolic and diastolic blood pressure

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

    comparing resting systolic and diastolic blood pressure (mmHg) 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  2. laboratory parameters

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

    comparing different laboratory parameters (derived by blood draw) like hormones, hemogram, liver and kidney function, and coagulation parameters 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  3. hair cortisol concentration

    Time frame: at baseline

    hair cortisol concentration by taking a small strand of hair is measured at baseline; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  4. resting heart rate

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

    comaparing resting heart rate(beats/minute) 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  5. waist to hip ratio

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

    comparing waist to hip ratio (cm) 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  6. markers of peripheral immunity

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

    comapring markers of peripheral immunity (e.g., monocytic HLA-DR expression) 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  7. lipid profile

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

    comparing lipide such as triglycerides, cholesterol (total, LDL,HDL, and LP(a)) 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  8. blood glucose

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

    comparing insulin, glucose, and HbA1c 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  9. markers of inflammation

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

    comparing markers of inflammation (e.g., including Interleukin (IL) 6, 1b, hs-CRP) 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  10. body mass index

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

    comparing body mass 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); part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  11. Endothelial function

    Time frame: directly after intervention vs. baseline

    the endothelial function of included patients will be assessed prospectively before and after the 4 week intervention with the Endopat2000 device. First measurement was conducted in January 11th 2014. Results will be correlated with imaging and blood-derived biomarkers as well as differences between intervention groups; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

  12. Magnetic resonance imaging parameters

    Time frame: directly after intervention vs. baseline

    Primary and secondary endpoints are specified after completion of the interim analysis after inclusion of the first 24 patients (first stage). In a second stage the study is conducted with specified primary and secondary endpoints with recruitment of up to 76 remaining patients; part of substudy 'Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)' - NCT01954797 (will be analyzed seperately)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 1, 2013
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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