Recruiting

Cardiac Rehabilitation

Sponsor:

Zhili hao

Code:

NCT04812600

Conditions

Cardiovascular Diseases

Vascular Stiffness

Endothelial Dysfunction

Eligibility Criteria

Sex: All

Age: 45 - 70

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cardiovascular Diseases

Vascular Stiffness

Endothelial Dysfunction

Study ID

NCT04812600

Start date

Mar 20, 2021

Status verified date

Mar, 2021

Completion date

Mar 20, 2022

Anticipated

Primary completion date

Mar 20, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Micro-tactile sensor assessment of arterial stiffness change to exercise [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation ]

Central Contacts and Locations

Central contacts

Julie Hao, Ph.D.

757-683-6734zlhao@odu.edu

Leryn Reynolds

757-683-4974lreynold@odu.edu

Locations

Sentara Heart Hospital

Recruiting

Norfolk, Virginia, United States, 23501

Contacts

Jennifer May, Ph.D.

757-388-1926jlfreema@sentara.com

More Information

Sponsor

Zhili hao

Last update posted

Mar 23, 2021

Last verified

Mar, 2021

Keywords

  • Exercise
  • vascular disease
  • cardiac rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zhili hao on 2021-03-23.