StrokeNCT02735616
Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls
An observational study of Stroke, run by Rabin Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Stroke
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2017
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- First stroke
- 1-3 weeks after the stroke
Who cannot join
- Pacemaker
- Cardiac arrhythmia
- Use of Beta- Blocker drugs
- Cerebellar deficit
- Mini-Mental State Examination (MMSE) < 18
Trial locations and contacts
No sites are listed yet.
About this study
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:
- 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.
Read the 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.
- Conditions
- Stroke
- Keywords
- heart rate variability, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability
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.
Measured: 3 days
step counter
Step counter by Polar loop. Stored in the device and transfer to a computer for analysis.
Measured: three days follow up, (24-hours X 3)
Secondary outcomes (4)
Stroke activity Scale
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.
Measured: At admission
Scandinavian Stroke Scale
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.
Measured: At admission
Functional Independence Measure
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.
Measured: At admission
Autonomic function questionnaire
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
Measured: At admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AVITAL HERSHKOVITZ, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735616
- Sponsor's protocol ID
- 008215rmc
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls
- ClinicalTrials.gov ID
- NCT02735616
- Acronym / sponsor ID
- 008215rmc
- Conditions
- Stroke
- Keywords
- heart rate variability, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- First stroke
- 1-3 weeks after the stroke
Key exclusion criteria (5 listed)
- Pacemaker
- Cardiac arrhythmia
- Use of Beta- Blocker drugs
- Cerebellar deficit
- Mini-Mental State Examination (MMSE) < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
heart rate variability
Time frame: 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.
step counter
Time frame: three days follow up, (24-hours X 3)
Step counter by Polar loop. Stored in the device and transfer to a computer for analysis.
4 secondary outcomes
Stroke activity Scale
Time frame: At admission
Scandinavian Stroke Scale
Time frame: At admission
Functional Independence Measure
Time frame: At admission
Autonomic function questionnaire
Time frame: At admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avital Hershkovitz, MD (972-3-9373841, avitalhe@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.