Unrecognized ConditionNCT03016416
The Influence of Rhythm, Cognitive Task and Physical Activity on the Cardiac ANS in Chronic Stroke Patients
An observational study of Unrecognized Condition, run by Clalit Health Services.
Trial summary
Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation outcomes and to increase in mortality. The severity of the autonomic dysfunction can be measured in many ways, but the most common way is assessment of the sympathetic-parasympathetic equilibrium by heart rate variability… Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Unrecognized Condition
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Dec 2017
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research will include two study groups, each with 16 participants. Participants in the study group will include 16 patients after first ischemic stroke, one sided, in the chronic phase. * Participants in the control group will include 16 healthy adults with equivalent age and lifestyle and without stroke history.
Who may be able to join
- All participants will be > 60 years, have Clalit health insurance, walking and Hebrew native speakers. Number of man and woman participating in the study will be equal.
Who cannot join
- Individuals with any of the following criteria will not participate in the study: participants with communication problems such as language, hearing or visual problems, recurrent strokes, cognitive deficiency (MoCA≤ 26) (Toglia et al., 2011), neglect by BIT - Star cancellation test (Wilsonet et al., 1987), patients with central or peripheral neurological problems, heart pacemaker and/or patients that use medications that effect the autonomic nerve system such asβ blockers, or use alcohol or drugs.
- Patients that suffer from background illness that can effect their ability to cycle such as knee OA.
About this study
Official title: The Influence of Rhythm, Cognitive Task and Physical Activity on the Cardiac Autonomic Nerve System in Chronic Stroke Patients and in a Control Group
Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation outcomes and to increase in mortality. The severity of the autonomic dysfunction can be measured in many ways, but the most common way is assessment of the sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that the plasticity of the brain can influence the autonomic nerve system and that providing appropriate stimuli encourages these changes. It was found that stimulation of rhythm, stimulation of cognitive tasks and stimulation of activity, influence the autonomic nerve system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive, rhythm) may influence the autonomic nervous system and cause an increase in brain activity, therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose of this study is to examine the influence of stimulation of rhythm, stimulation of cognition, stimulation of activity and combined stimulation, on the autonomic nerve system. This effect will be tested by measuring heart rate variability in chronic stroke patients and in a control group.
Read the detailed description
background and Rationale: Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation outcomes and to increase in mortality. Although this dysfunction is a common symptom of stroke, both in the acute phase and in the chronic phase, it is not a specific therapeutic target yet. The severity of the autonomic dysfunction can be measured in many ways, but the most common way is assessment of the sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that the plasticity of the brain can influence the autonomic nerve system and that providing appropriate stimuli encourages these changes. It was found that stimulation of rhythm, stimulation of cognitive tasks (in particular, stimulation of executive functions) and stimulation of activity, influence the autonomic nerve system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive, rhythm) may influence the autonomic nervous system and cause an increase in brain activity, therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose of this study is to examine the influence of stimulation of rapid or slow rhythm, stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness bike and combined stimulation, on the autonomic nerve system. This effect will be tested by measuring heart rate variability in chronic stroke patients and in a control group with equivalent age and lifestyle.
The Medical Device:
Heart rate and heart rate variability will be monitored by Polar RS800CX watch (PolarElectro OY, Kempele, Finland(. A transmitter placed on the patient's chest will collect the data. This data will be stored in the watch's computer and then analyzed in a specific Polar software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a preliminary study. Pedaling capability, RPM, will be collected from cadence sensor with Bluetooth smart.
The Purpose of this Medical Research:
The purpose of this study is to examine the influence of stimulation of rapid or slow rhythm, stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness bike and combined stimulation, on the autonomic nerve system in chronic stroke patients and in a control group with equivalent age and lifestyle.
- Conditions
- Unrecognized Condition
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 |
|---|---|---|
| chronic stroke patients | Participants for the study group will be recruited from the Clalit Health Services- Ben Yair Rehabilitation Center in Jaffa Israel. | |
| control group | The control group will be with equivalent age and lifestyle as the studt group. Participants for the control group will be recruited via solicitation adds at the Ben Yair Rehabilitation Center and at near-by clinics. |
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 monitored by Polar RS800CX watch (PolarElectro OY, Kempele, Finland). A transmitter put on the patient's chest will collect the data. This data will be stored in the watch's computer and then analyzed in a specific Polar software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a preliminary study.
Measured: 90 min
Secondary outcomes (2)
Pedaling capability
Pedaling capability, rpm, will be collected from cadence sensor with Bluetooth smart
Measured: 25 min
Cognitive outcomes
Cognitive outcomes will be evaluated by Digit Span, a sub section of Wechsler Adult Intelligence test (Choi et al., 2014).
Measured: 10 min task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionDec 2017 (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 Unrecognized ConditionStudies 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
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alon Erez, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016416
- Sponsor's protocol ID
- 0063-16-COM
- Status last verified
- Jan 2017
- First submitted
- 25 Dec 2016
- Last updated
- 10 Jan 2017
- 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 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Rhythm, Cognitive Task and Physical Activity on the Cardiac Autonomic Nerve System in Chronic Stroke Patients and in a Control Group
- ClinicalTrials.gov ID
- NCT03016416
- Acronym / sponsor ID
- 0063-16-COM
- Conditions
- Unrecognized Condition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jan 2017 (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.
Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation outcomes and to increase in mortality. The severity of the autonomic dysfunction can be measured in many ways, but the most common way is assessment of the sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that the plasticity of the brain can influence the autonomic nerve system and that providing appropriate stimuli encourages these changes. It was found that stimulation of rhythm, stimulation of cognitive tasks and stimulation of activity, influence the autonomic nerve system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive, rhythm) may influence the autonomic nervous system and cause an increase in brain activity, therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose of this study is to examine the influence of stimulation of rhythm, stimulation of cognition, stimulation of activity and combined stimulation, on the autonomic nerve system. This effect will be tested by measuring heart rate variability in chronic stroke patients and in a control group.
Detailed description
background and Rationale: Autonomic dysfunction is a common complication of stroke that may lead to poor rehabilitation outcomes and to increase in mortality. Although this dysfunction is a common symptom of stroke, both in the acute phase and in the chronic phase, it is not a specific therapeutic target yet. The severity of the autonomic dysfunction can be measured in many ways, but the most common way is assessment of the sympathetic-parasympathetic equilibrium by heart rate variability analysis. It is known that the plasticity of the brain can influence the autonomic nerve system and that providing appropriate stimuli encourages these changes. It was found that stimulation of rhythm, stimulation of cognitive tasks (in particular, stimulation of executive functions) and stimulation of activity, influence the autonomic nerve system in healthy subjects. Thus, we can ask if an integrated task (activity, cognitive, rhythm) may influence the autonomic nervous system and cause an increase in brain activity, therefore contributing to the rehabilitation of stroke patients. Taken together, the purpose of this study is to examine the influence of stimulation of rapid or slow rhythm, stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness bike and combined stimulation, on the autonomic nerve system. This effect will be tested by measuring heart rate variability in chronic stroke patients and in a control group with equivalent age and lifestyle.
The Medical Device:
Heart rate and heart rate variability will be monitored by Polar RS800CX watch (PolarElectro OY, Kempele, Finland(. A transmitter placed on the patient's chest will collect the data. This data will be stored in the watch's computer and then analyzed in a specific Polar software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a preliminary study. Pedaling capability, RPM, will be collected from cadence sensor with Bluetooth smart.
The Purpose of this Medical Research:
The purpose of this study is to examine the influence of stimulation of rapid or slow rhythm, stimulation of cognition by cognitive tasks, stimulation of activity by pedaling a fitness bike and combined stimulation, on the autonomic nerve system in chronic stroke patients and in a control group with equivalent age and lifestyle.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic stroke patients | – | –Participants for the study group will be recruited from the Clalit Health Services- Ben Yair Rehabilitation Center in Jaffa Israel. |
| control group | – | –The control group will be with equivalent age and lifestyle as the studt group. Participants for the control group will be recruited via solicitation adds at the Ben Yair Rehabilitation Center and at near-by clinics. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research will include two study groups, each with 16 participants. Participants in the study group will include 16 patients after first ischemic stroke, one sided, in the chronic phase. * Participants in the control group will include 16 healthy adults with equivalent age and lifestyle and without stroke history.
Key inclusion criteria (1 listed)
- All participants will be > 60 years, have Clalit health insurance, walking and Hebrew native speakers. Number of man and woman participating in the study will be equal.
Key exclusion criteria (2 listed)
- Individuals with any of the following criteria will not participate in the study: participants with communication problems such as language, hearing or visual problems, recurrent strokes, cognitive deficiency (MoCA≤ 26) (Toglia et al., 2011), neglect by BIT - Star cancellation test (Wilsonet et al., 1987), patients with central or peripheral neurological problems, heart pacemaker and/or patients that use medications that effect the autonomic nerve system such asβ blockers, or use alcohol or drugs.
- Patients that suffer from background illness that can effect their ability to cycle such as knee OA.
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: 90 min
Heart rate variability will be monitored by Polar RS800CX watch (PolarElectro OY, Kempele, Finland). A transmitter put on the patient's chest will collect the data. This data will be stored in the watch's computer and then analyzed in a specific Polar software (Polar Protrainer 5 inc.). An appropriate filtration will be made after a preliminary study.
2 secondary outcomes
Pedaling capability
Time frame: 25 min
Cognitive outcomes
Time frame: 10 min task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Unrecognized Condition, run by Clalit Health Services.
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 1 inclusion and 2 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 10 Jan 2017. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 90 min). 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 10 Jan 2017.