Skip to content

Microfluidic-based Tactile Sensor in Cardiac Rehabilitation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04812600
Enrollment
30
Registered
2021-03-23
Start date
2021-03-20
Completion date
2022-03-20
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Endothelial Dysfunction, Vascular Stiffness

Keywords

Exercise, vascular disease, cardiac rehabilitation

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.

Interventions

None listed

Sponsors

Eastern Virginia Medical School
CollaboratorOTHER
Zhili hao
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Micro-tactile sensor assessment of arterial stiffness change to exerciseThe change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitationElasticity (unit measure: pascal) of arterial wall will be assessed.
Micro-tactile sensor assessment of arterial viscosity change to exerciseThe change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitationDamping (unit measure: pascal x sec) of the arterial wall will be assessed.
Micro-tactile sensor assessment of arterial radius change to exerciseThe change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitationSize of the artery lumen (unit measure: mm) will be assessed.
Automated blood pressure device assessment of systolic and diastolic blood pressure change to exerciseThe change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitationSystolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.

Countries

United States

Contacts

Primary ContactJulie Hao, Ph.D.
zlhao@odu.edu757-683-6734
Backup ContactLeryn Reynolds
lreynold@odu.edu757-683-4974

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026