Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Phase 3

Completed

• Conditions: Stroke
• Interventions: Procedure: physical fitness training; Procedure: relaxation

• Registration Number: NCT01953549
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-09-26
• Study Start: 2013-10
• Study First Posted: 2013-10-01
• Primary Completion: 2017-07-06
• Study Completion: 2017-11-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical fitness training	physical fitness training	aerobic physical fitness training
relaxation	relaxation	non-aerobic training

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of life (QoL)	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)
mood	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)
Gait speed and Barthel Index (BI)	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)
motor function	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)
cognitive function	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)
sleep	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)
Assessment of safety	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)
mobility	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)
Disability	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)
Physical fitness	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)
Maximal walking speed and Barthel-Index	3 months post stroke vs. baseline	per Protocol analysis of co-primary endpoint (pre-specified in statistical analysis plan and protocol)

Trial Locations

Locations (7)

Beelitz Heilstätten; 🇩🇪 Beelitz Heilstatten, Brandenburg, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Vivantes Klinikum Neukölln; 🇩🇪 Berlin, Germany

Evanglisches Geriatriezentrum Berlin; 🇩🇪 Berlin, Germany

Median Klinik Grünheide; 🇩🇪 Grunheide, Brandenburg, Germany

Medical Park Berlin; 🇩🇪 Berlin, Germany

Charité Campus Benjamin Franklin; 🇩🇪 Berlin, Germany