Ischemic Stroke Clinical Trial
— EXERTIONOfficial title:
Aerobic Exercise in the the Early Stroke Rehabilitation - Effects on Motor Function, Cognition, Physical Comfort and the Immune System
Verified date | May 2024 |
Source | University Hospital Muenster |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical trial is to study the effects of aerobic exercise during the early rehabilitation after ischemic stroke. The main questions it aims to answer are: - How is the recovery of motor function affected by regularly walking during the first 90 days after an ischemic stroke? - Does regularly walking during the first 90 days after ischemic stroke affect cognition, physical comfort and the immune system? Participants will exert a heart rate controlled walking programme of walking 3-5 times 30-45 minutes per week. Researchers will compare the recovery of the walking group to a control group without any demands regarding physical exercise.
Status | Completed |
Enrollment | 39 |
Est. completion date | February 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - initial NIHSS or NIHSS determined at the moment of maximum deterioration 1-18 - age > 18 - ischemic stroke - pre-stroke independence - sufficient motivation / patient's desire to cooperate / exercise for 3-5x/week for 30-45 min Exclusion Criteria: - transient ischemic attack - premorbid motor disability / musculoskeletal injury / severe arthritis impairing degree of movement - balance and transfer function that requires assistance - cardiac disease not allowing to perform aerobic training - inability to give informed consent |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Münster | Münster | Northrine-Westphalia |
Lead Sponsor | Collaborator |
---|---|
University Hospital Muenster |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Motor function | Recovery of motor function is assessed by fugl-meyer assessment (FMA). The FMA-UE (upper extremity) is measured in a score with a maximum of 66 points for motor function, the FMA-LE (lower extremity) extends up to a sum score of 34 points for motor function. | 90 days | |
Secondary | Cognition | A MoCA (Montreal Cognitive Assessment) is performed. The evaluation takes place via the calculation of demographically corrected standard values (the z-value): https://www.mocatest.ch/de/standardwerte/standardwerte-online-berechnen.
In addition, the SDMT (Symbol Digites Modality Test) is performed. The evaluation takes places via evaluation of the sum score in a age and education adjusted manner as stated in the following publication: Kiely KM et al. Arch Clin Neuropsychol. 2014. |
90 days | |
Secondary | Fatigue | The effect of aerobic exercise on fatigue after ischemic stroke will be assessed by neuropsychological testing. The FSMC (Fatigue Scale for Motor and Cognitive Functions) is performed. A total score is calculated after the patient has completed the questionnaire.
These cut-off values have been validated by Penner et al, 2009, Mult Scler. 2009. |
90 days | |
Secondary | Physical Comfort | The HADS-S (Hospital Anxiety and Depression Scale; German Version) is performed. The score consists of 14 items, 7 each for depression and anxiety which are arranged in alternating order. After the patient has completed the questionnaire, two dimension are analyzed via building to sub-scores.
The cut-off values are derived from Herrmann-Lingen, C., Buss, U., & Snaith, R. P. (2011). Furthermore, physical comfort is assessed by the WHODAS (World Health Organization Disability Assessment Schedule). The 12-item questionnaire is self-administered and we focus on the symptoms during the last 14 days. Each item/question is assigned a value from 0 to 4 and a sum score is calculated. The score is interpreted adjusted to age, gender and physical condition as proposed in the following publication: Andrews G, et al. PLoS One. 2009. |
90 days | |
Secondary | Flow cytometry analysis of cryoasservated peripheral blood mononuclear cells (PBMC) | Blood sampling is performed at baseline and on day 90 after study inclusion. In our analysis, we focus on the major leukocyte subtypes. Of these, effector functions such as cytokine production, differentiation and activation levels, and expression of regulatory molecules will also be determined. The major measurement by flow cytometry analysis will be the percentage of the expressed target in the interventional cohort compared to the control group. | 90 days | |
Secondary | Structural axonal changes | Fibre tract density is assessed by cerebral magnetic resonance imaging (MRI-DTI). | 90 days |
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