Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02735616
Collaborator
(none)
30
20

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls
    Study Start Date :
    Apr 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. heart rate variability [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.

    2. step counter [three days follow up, (24-hours X 3)]

      Step counter by Polar loop. Stored in the device and transfer to a computer for analysis.

    Secondary Outcome Measures

    1. Stroke activity Scale [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.

    2. Scandinavian Stroke Scale [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.

    3. Functional Independence Measure [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.

    4. Autonomic function questionnaire [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AVITAL HERSHKOVITZ, Avital Hershkovitz, Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT02735616
    Other Study ID Numbers:
    • 008215rmc
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Apr 13, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by AVITAL HERSHKOVITZ, Avital Hershkovitz, Rabin Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 13, 2016