Clinical trial NCT02735616: Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls
Official title: Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: heart rate variability
stroke
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: heart rate variability
timeFrame: 3 days
measure: step counter
timeFrame: three days follow up, (24-hours X 3)
Secondary outcomes:
measure: Stroke activity Scale
timeFrame: At admission
measure: Scandinavian Stroke Scale
timeFrame: At admission
measure: Functional Independence Measure
timeFrame: At admission
measure: Autonomic function questionnaire
timeFrame: At admission
Other outcomes:
Locations:
Study officials:
References: