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

Unrecognized Condition Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03016416
• Other study ID #: 0063-16-COM
• Status: Not yet recruiting
• Phase: N/A
• First received: December 25, 2016
• Last updated: January 8, 2017
• Start date: February 2017
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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 asß blockers, or use alcohol or drugs.

• Patients that suffer from background illness that can effect their ability to cycle such as knee OA.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Unrecognized Condition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pedaling capability	Pedaling capability, rpm, will be collected from cadence sensor with Bluetooth smart	25 min	No
Secondary	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	No