Clinical trial NCT04812600: Microfluidic-based Tactile Sensor in Cardiac Rehabilitation
Official title: Microfluidic-based Tactile Sensor for Arterial Pulse Signal Measurements in Patients Going Through Cardiac Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Vascular Stiffness
Endothelial Dysfunction
Keywords: Exercise
vascular disease
cardiac rehabilitation
Lead sponsor: Old Dominion University
Sponsor class: OTHER
Collaborators: name: Eastern Virginia Medical School
First posted: 2021-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are undergoing Phase II (outpatient) cardiac rehabilitation at Sentara Heart Hospital (Norfolk, Va) and meet the inclusion and exclusion criteria listed will be recruited for the study.

Brief summary: This study will examine the impact of cardiac rehabilitation on blood vessel health using a newly developed microfluidic-based tactile sensor to assess blood vessel health. The participants will have their blood vessel health measured using a sensor that is placed on top of the skin over the artery before and after exercise (1, 3, 5, 10, 30 and 60 mins). The investigators will study these responses at the first session of cardiac rehabilitation and following 1 and 4 weeks of cardiac rehabilitation (sessions 3 and 6). The investigators will also collect some information from the medical record regarding: age, gender, body mass index, resting cardiovascular measures (heart rate, blood pressure etc), medications, reasons which qualified the participant into cardiac rehabilitation, blood tests related to heart or cardiovascular function, metabolic panel, lipid panel, echocardiogram results, recorded electrocardiogram, known vascular diseases, presence of implantable devices, Seattle Heart Failure Model data and cardiovascular measures and exercise workloads during cardiac rehabilitation.

Detailed description: The investigators will make the following research measurements (pre-exercise measurement and post-exercise measurement) on the first day of cardiac rehab, and following 1 and 4 weeks of cardiac rehabilitation.

Subjects will have their arterial pulse measured at the radial (wrist), carotid (neck) and temple (side of the head) arteries. The sensor will remain in place for 2-3 minutes while the recordings are made. Light pressure will be applied during this time. Blood pressure will also be obtained in the opposite arm.

The subject will then exercise on the modalities, intensity and duration designated by the staff in the Sentara Heart Hospital Cardiac Rehabilitation. It's important to note, that the normal standard of care will not change by the individual participating in this research study. The participants will follow standard physician ordered cardiac rehabilitation. The order of the modalities performed will be completed in the same order on the day of research testing in weeks 1 and 4.

After finishing the exercise, the subject will sit down for 1hr. The participant's pulse signals will be measured at 0-5min, 10min, 20 min, 30min and 1hr after exercise. Blood pressure will also be obtained from the opposite arm at the same time intervals.

The investigators will be collecting cardiac rehab data from each research day. This data will be entered into Redcap by the Sentara researchers.

The investigators will record from the most recent values/visits prior to start of cardiac rehab therapy, and this information will be entered into Redcap by the Sentara researchers.

The investigators will document at 1, 2 and 3 years from start of cardiac rehab, as to patient survival status.

Eligibility criteria: Inclusion Criteria:

* Age 45-70
* Subjects who qualify for cardiac rehabilitation via doctor's orders

Exclusion Criteria:

●Physical limitations which would preclude one from performing exercise.

Primary outcomes:
measure: Micro-tactile sensor assessment of arterial stiffness change to exercise
timeFrame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
measure: Micro-tactile sensor assessment of arterial viscosity change to exercise
timeFrame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
measure: Micro-tactile sensor assessment of arterial radius change to exercise
timeFrame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
measure: Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise
timeFrame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
Study officials:
affiliation: Old Dominion University
name: Julie Hao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: