The Influence of Rhythm, Cognitive Task and Physical Activity on the Cardiac ANS in Chronic Stroke Patients

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.

Study Overview

• Status: Unknown
• Conditions: Unrecognized Condition

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 Type: Observational
• Enrollment (Anticipated): 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pedaling capability	Pedaling capability, rpm, will be collected from cadence sensor with Bluetooth smart	25 min
Cognitive outcomes	Cognitive outcomes will be evaluated by Digit Span, a sub section of Wechsler Adult Intelligence test (Choi et al., 2014).	10 min task

Collaborators and Investigators

• Sponsor: Clalit Health Services

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 25, 2016
• First Submitted That Met QC Criteria: January 8, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 8, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 0063-16-COM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No