- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Hillerød, Danimarca, 3400
- Hillerød Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Low Dose Training
15 minutes/day on a weight-bearing treadmill
|
weight-bearing treadmill, pulsereserve increase of 50 %
|
|
Comparatore attivo: High Dose Training
2x 30 minutes/day on a weight-bearing treadmill
|
weight-bearing treadmill, pulsereserve increase of 50 %
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
change in disability from baseline
Lasso di tempo: up to 5 days
|
Scandinavian Stroke Scale (SSS)
|
up to 5 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
change in inflammation level from baseline
Lasso di tempo: up to 5 days
|
biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Nekrosis Factor(TNF)-alpha, C-Reactive Proteine (CRP), IL-1ra, IL-10, fasting-insuline, fasting-glucose
|
up to 5 days
|
|
change in disability from baseline
Lasso di tempo: up to 5 days
|
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)
|
up to 5 days
|
|
changes and level of activity during up to 5 days of hospitalization
Lasso di tempo: up to 5 days
|
activity counts per day measured by an accelerometer
|
up to 5 days
|
|
number of complications per patient
Lasso di tempo: up to 30 days
|
all complications are counted from inclusion till day 30 in all patients
|
up to 30 days
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 30704 part 2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .