Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls
By Investigating the heart rate variability (HRV) of 15 patients after stroke and compare it to the HRV of 15 orthopedic patients, the investigators hope to achieve 3 main goals:
1. To describe the 24-hour circadian rhythm of heart rate among patients after stroke in the sub-acute phase during 3 days. 2. To examine the differences in the circadian rhythm of heart rate along 3 days between patients after stroke in the sub-acute phase and control group matched by age and gender. 3. To describe the reaction and examine the differences in reactions of the heart autonomic system during rest, paced breathing and activity in both groups- stoke and control.
The HRV will be monitored by Polar watch and the activity will be measured by accelerometer, both will be attached to the patients at the beginning of the trial and will stay on them for 3 whole days.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Background: Evaluating the autonomic system is conducting, among others, by comparing the relationships between the two sub-systems that assembler it: the sympathetic and the parasympathetic systems. In normal conditions, there is balance between both systems which reflects in a highly dynamic heart rate and heart rate variability. As part of the brain injury after stroke, the autonomic system is also damaged. The heart rate variability is decreased and the 24-hour circadian rhythm of heart rate changes.
Purposes of the research: 1. To describe the 24-hour circadian rhythm of heart rate among patients after stroke in the sub-acute phase during 3 days. 2. To examine the differences in the circadian rhythm of heart rate along 3 days between patients after stroke in the sub-acute phase and control group matched by age and gender. 3. To describe the reaction and examine the differences in reactions of the heart autonomic system during rest, paced breathing and activity in both groups- stoke and control.
Methods:
Population: 15 patients after cerebrovascular accident (CVA), 1-3 weeks after the stroke. The patients will be hospitalized in the neurology department at the geriatric "Beit-Rivka" hospital. The control group will be 15 patients from the orthopedic department of the hospital' matching by age and gender. Tools: monitoring heart rate and heart rate variability by Polar watch (Polar RS800CX heart rate monitor). Monitoring activity will measure by accelerometer. Methods: after attaching to RS800CX watch, each participant will complete two tests: the response of heart rate to deep breathing and the response of heart rate variability to prolonged hand grip. The department nurse will be asked to answer a questionnaire regarding autonomic functions and the examiner will asses the functional independence of the participant by the "Functional Independence Measure" (FIM). In the research group will be additional assessments regarding the motor function by the "Stroke Activity Scale" and the "Scandinavian Stroke Scale". The watch and the accelerometer will stay on the participant for 3 day (72 hours) and the records regarding the daily activity such as meals, sleep, and all kind of treatments will be taken from the department's diary. At the end of three days, the data will be collected and analyzed on computer software.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
15 CVA patients that are hospitalized in the neurology department at the geriatric "Beit-Rivka" hospital in Israel.
The control group will be 15 patients from the orthopedic department of the hospital, matching by age and gender
Descrizione
Inclusion Criteria:
- First stroke
- 1-3 weeks after the stroke
Exclusion Criteria:
- Pacemaker
- Cardiac arrhythmia
- Use of Beta- Blocker drugs
- Cerebellar deficit
- Mini-Mental State Examination (MMSE) < 18
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
study
15 CVA patients, 1-3 weeks after their first stroke. The patients will be hospitalized in the neurology department at the geriatric "Beit-Rivka" hospital at Petah-Tiva, Israel. patients with pacemaker or those who use Beta-Blocker drugs, as well as patients with cerebellar injury, will be excluded from the research |
|
control
15 patients from the orthopedic department at the same hospital, matching by age and gender to the study group.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
heart rate variability
Lasso di tempo: 3 days
|
Heart rate variability will be measured by Polar watch at the beginning of each day during the 3 days of the research.
At the end of those days, the data will be collected and analyzed on computer software.
|
3 days
|
|
step counter
Lasso di tempo: three days follow up, (24-hours X 3)
|
Step counter by Polar loop.
Stored in the device and transfer to a computer for analysis.
|
three days follow up, (24-hours X 3)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Stroke activity Scale
Lasso di tempo: At admission
|
A 5 items scale who measures the motor function at the level of disability in stroke patients.
The functions included are getting out of bed, static and dynamic sitting balance, sitting to standing, stepping and walking and bringing a glass to the mouth.
|
At admission
|
|
Scandinavian Stroke Scale
Lasso di tempo: At admission
|
A 9 items scale (consciousness; eye movements; arm motor power; hand motor power; leg motor power; orientation; speech; facial palsy and gait) to assess neurological status.
|
At admission
|
|
Functional Independence Measure
Lasso di tempo: At admission
|
18 items scale designed to assess the amount of assistance required for a person with a disability to perform basic life activities safely and effectively.
The activities include a mini- mum set of skills related to self-care, sphincter control, trans- fers, locomotion, communication, and social cognition.
|
At admission
|
|
Autonomic function questionnaire
Lasso di tempo: At admission
|
Based on the Svedberg questionnaire, originally made for children with cerebral palsy (CP) to describe symptoms such as cold extremities, constipation, pain, sleeping disorders and impaired well-being
|
At admission
|
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 008215rmc
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .