Physical Fitness Training in Subacute Stroke (PHYS-Stroke)

Active, not recruiting

Phase 3 Results N/A

Trial Description

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

Interventions

  • Physical fitness training Procedure
    ARM 1: Kind: Experimental
    Label: physical fitness training
    Description: aerobic physical fitness training
  • Relaxation Procedure
    ARM 1: Kind: Experimental
    Label: relaxation
    Description: non-aerobic training

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Gait speed and Barthel Index (BI) (co-primary endpoint) 3 months post stroke vs baseline No
Secondary Gait speed and Barthel Index (BI) directly after intervention; 6 months post stroke; all vs baseline No
Secondary motor function directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary mobility directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary cognitive function directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary Disability directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary Quality of life (QoL) directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary sleep directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary mood directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary Physical fitness directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline No
Secondary resting systolic and diastolic blood pressure directly after intervention; 3 months post stroke; 6 months post stroke, all vs baseline No
Secondary laboratory parameters directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary hair cortisol concentration at baseline No
Secondary Assessment of safety directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline Yes
Secondary resting heart rate directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary body mass index directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary waist to hip ratio directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary markers of inflammation directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary markers of peripheral immunity directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary blood glucose directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No
Secondary lipid profile directly after intervention; 3 months post stroke; 6 months post stroke; all vs baseline No

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