Microfluidic-based Tactile Sensor in Cardiac Rehabilitation

Microfluidic-based Tactile Sensor for Arterial Pulse Signal Measurements in Patients Going Through Cardiac Rehabilitation

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Endothelial Dysfunction; Vascular Stiffness

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23501
      • Recruiting
      • Sentara Heart Hospital
      • Contact: Jennifer May, Ph.D.; Phone Number: 757-388-1926; Email: jlfreema@sentara.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac Rehabilitation; Individuals assigned to phase II (outpatient) cardiac rehabilitation program will undergo their normal exercise routines while the investigators make the measurements pre and post exercise at 0 week, and following 1 and 4 weeks of exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Micro-tactile sensor assessment of arterial stiffness change to exercise	Elasticity (unit measure: pascal) of arterial wall will be assessed.	The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Micro-tactile sensor assessment of arterial viscosity change to exercise	Damping (unit measure: pascal x sec) of the arterial wall will be assessed.	The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Micro-tactile sensor assessment of arterial radius change to exercise	Size of the artery lumen (unit measure: mm) will be assessed.	The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise	Systolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.	The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation

Collaborators and Investigators

• Sponsor: Zhili hao
• Collaborators: Eastern Virginia Medical School
• Investigators: Principal Investigator: Julie Hao, Ph.D., Old Dominion University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 20, 2021
• Primary Completion (Anticipated): March 20, 2022
• Study Completion (Anticipated): March 20, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; cardiac rehabilitation; vascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 19-04-FB-0100

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No