- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04812600
Microfluidic-based Tactile Sensor in Cardiac Rehabilitation
Microfluidic-based Tactile Sensor for Arterial Pulse Signal Measurements in Patients Going Through Cardiac Rehabilitation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Leryn Reynolds
- Telefonnummer: 757-683-4974
- E-mail: lreynold@odu.edu
Undersøgelse Kontakt Backup
- Navn: Julie Hao, Ph.D.
- Telefonnummer: 757-683-6734
- E-mail: zlhao@odu.edu
Studiesteder
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Virginia
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Norfolk, Virginia, Forenede Stater, 23501
- Rekruttering
- Sentara Heart Hospital
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Kontakt:
- Jennifer May, Ph.D.
- Telefonnummer: 757-388-1926
- E-mail: jlfreema@sentara.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Micro-tactile sensor assessment of arterial stiffness change to exercise
Tidsramme: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Elasticity (unit measure: pascal) of arterial wall will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Micro-tactile sensor assessment of arterial viscosity change to exercise
Tidsramme: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Damping (unit measure: pascal x sec) of the arterial wall will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Micro-tactile sensor assessment of arterial radius change to exercise
Tidsramme: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Size of the artery lumen (unit measure: mm) will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Automated blood pressure device assessment of systolic and diastolic blood pressure change to exercise
Tidsramme: The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Systolic and diastolic blood pressure (unit measure: mmHg) of the artery will be assessed.
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The change of up to 1 hour post exercise relative to pre-exercise, at 0 weeks, 1 week and 4 weeks of cardiac rehabilitation
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Julie Hao, Ph.D., Old Dominion University
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 19-04-FB-0100
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Hjerte-kar-sygdomme
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Ottawa Hospital Research InstituteAfsluttetStress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdighederCanada