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- Essai clinique NCT01594190
Physical Activity Immediately After Acute Cerebral Ischemia
Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much - a Randomized Controlled Study
Stroke is the leading cause of adult disability in Europe and United States and the second leading cause of death worldwide and affects more than 10,000 Danes each year.
Studies in a late and stationary phase after stroke have shown that physical rehabilitation is of great importance for survival and physical ability of these patients, however many studies show that patients lie or sit next to their bed under hospitalization for more than 88.5 % of the daily hours. Physical activity in stroke patients has never previously been measured immediately after debut of symptoms; furthermore there is no knowledge about the optimal dose of physical rehabilitation for these patients.
Accelerometers, small measuring devices, are a relatively new way to measure physical activity precisely, and hence it is possible to obtain an objective measure of how active stroke patients are in the first week after admission. The accelerometers measure a variable voltage, depending on the range and intensity of movement. They can measure movement dependent of the placement of the accelerometer, for instance over the hip, arm or leg. Studies confirm their reliability, even in patients with abnormal gait, such as stroke patients.
Another approach of studying the effects of physical activity and rehabilitation is through the examination of biomarkers. Studies have shown that biomarkers released during physical activity can inhibit biomarkers released after tissue injury in the brain, as seen after stroke. These brain biomarkers cause further damage and studies show that the higher the levels, the higher the damage. It is therefore obvious to examine whether physical activity rehabilitation can down regulate this destructive process in patients with stroke.
Clarification of the optimal dose of physical activity in stroke patients immediately after debut of symptoms and examination of both the biochemical aspects of physical rehabilitation as well as the optimal dose of physical rehabilitation is of great importance for many patients, their relatives as well as of a great socioeconomic importance.
The purpose of the project is to investigate which dose (15 vs. 2 x 30 minutes) of physical activity on a weight-bearing treadmill in the first 5 days after admission after an ischemic stroke, gives patients the best improvement in neurological dysfunction.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Anna Maria Strømmen, MD
- Numéro de téléphone: +4548297353
- E-mail: amic@noh.regionh.dk
Lieux d'étude
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Hillerød, Danemark, 3400
- Hillerød Hospital
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Chercheur principal:
- Anna Maria Strømmen, MD
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Contact:
- Anna Maria Strømmen, MD
- Numéro de téléphone: +4548297353
- E-mail: amic@noh.regionh.dk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients admitted with acute ischemic stroke
- age > 18 years
- first stroke or only minor invalidity from previous strokes (mRS 0-2)
- truncal stability
- SSS < 58
Exclusion Criteria:
- symptoms attributable to other diseases than ischemic stroke
- debut of symptoms > 48 h prior to admission
- consent not given < 24 h of admission
- pregnancy or lactation
- isolation
- blood sampling generally not possible
- allergy due to accelerometer wear
- ulcers or other skin diseases in the area of accelerometer placement
- unstable cardiologic condition (AMI etc.)
- acute high and sustained resting systolic blood pressure where treatment is necessary
- acute heart rhythm disorder where treatment is necessary
- unable to cooperate
- significant orthopedic conditions (fractures etc.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Low Dose Training
15 minutes/day on a weight-bearing treadmill
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weight-bearing treadmill, pulsereserve increase of 50 %
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Comparateur actif: High Dose Training
2x 30 minutes/day on a weight-bearing treadmill
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weight-bearing treadmill, pulsereserve increase of 50 %
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change in disability from baseline
Délai: up to 5 days
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Scandinavian Stroke Scale (SSS)
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up to 5 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change in inflammation level from baseline
Délai: up to 5 days
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biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose
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up to 5 days
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change in disability from baseline
Délai: up to 5 days
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National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS)
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up to 5 days
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changes and level of activity during up to 5 days of hospitalization
Délai: up to 5 days
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activity counts per day measured by an accelerometer
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up to 5 days
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number of complications per patient
Délai: up to 30 days
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all complications are counted from inclusion till day 30 in all patients
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up to 30 days
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Nécrose
- Maladies cardiovasculaires
- Maladies vasculaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Infarctus
- Accident vasculaire cérébral
- Infarctus cérébral
- AVC ischémique
- Ischémie cérébrale
- Ischémie
- Infarctus cérébral
Autres numéros d'identification d'étude
- 30704 part 2
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Essais cliniques sur physical activity 15 minutes/day
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Universiteit AntwerpenUniversity Hospital, Antwerp; Cliniques universitaires Saint-Luc- Université...RecrutementHémophilie A | Hémophilie BBelgique