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Investigation of a Link Between Heart Rate Variability and Frailty in Geriatric Patients

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ClinicalTrials.gov Identifier: NCT03585985
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
The aim of this study is the evaluation of differences in heart rate variability (both time- and frequency-domain) [a]: between frail and non-frail patients and [b] at the beginning and end of a geriatric therapy which included rehabilitation components. Moreover, the suitability of new camera-based technology with regard to measurement of vital signs (heart rate, heart rate variability, respiratory rate) will be evaluated.

Condition or disease Intervention/treatment
Fragility Procedure: Standard patient monitor Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)

Detailed Description:

Frailty is an important geriatric syndrome, which indicates a reduced maximum resilience of patients and their organ system against external stressors. According to Fried's classification, frailty comprises of unintentional weight loss, exhaustion, muscle weakness, slowness while walking and low levels of activity. In geriatric patients, frailty is associated with a higher mortality and morbidity. Moreover, frailty patients are more often dependent on assistance after hospitalisation than non-frailty patients.

During geriatric therapy, geriatric patients are treated with multimodal rehabilitation comprising of activating nursing, physiotherapy, occupational therapy, psychiatric and speech therapy in order to increase mobility and patients' ability to help themselves. Success of rehabilitation measures is measured using the geriatric assessment (e.g. Barthel Index, Timed up and go test, Mini-Mental State Examination, Geriatric Depression Scale, measurement of hand power) at the beginning and end of the therapy. This geriatric therapy including the named geriatric assessment is not study-specific and is not prescribed by a study protocol, but is a routine treatment for frail patients.

Apart from these routinely used tests, recent literature indicated that heart rate variability, which can be easily measured with an ECG, could be an indicator for frailty. Beyond the medical problem whether heart rate variability can be used as a surrogate parameter for frailty, this study also has a technical aspect. In biomedical engineering, non-contact monitoring of vital signs has been an important and promising development in the last decade. Therefore, this study will also investigate if camera-based technologies such as photoplethysmography imaging (PPGI) and infrared thermography (IRT) can be used in a clinical environment for non-contact measurement of vital signs (heart rate, heart rate variability, respiratory rate) in geriatric patients. In this study, monitoring (with conventional and contactless technologies) should not trigger any observable/examining effect, but is merely a means to the end of observing the already existing HRV (and other vital parameters).


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigation of a Link Between Heart Rate Variability and Frailty in Geriatric Patients Before and After Rehabilitation With Simultaneous Evaluation of a New Camera-based Technology for Measurement of Vital Signs
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : July 30, 2019

Group/Cohort Intervention/treatment
Group 1
10 patients aged above 70 years with typical geriatric multimorbidity or aged above 80 years otherwise, patient in the hospital Franziskushospital Aachen on the ward of geriatric medicine
Procedure: Standard patient monitor
Measurement of reference data: heart rate, heart rate variability and respiratory rate

Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)
Camera-based technology for the determination of heart rate variability (PPGI) and contactless measurement of breathing rate (IRT)

Group 2
10 healthy elderly people above 70 years, healthy
Procedure: Standard patient monitor
Measurement of reference data: heart rate, heart rate variability and respiratory rate

Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)
Camera-based technology for the determination of heart rate variability (PPGI) and contactless measurement of breathing rate (IRT)




Primary Outcome Measures :
  1. Link between heart rate variability and frailty [ Time Frame: approx. 14 days (duration of geriatric complex therapy) ]

    heart rate variability is measured by ECG; frailty is evaluated by geriatric assessment (questionnaires)

    both investigations are not related to the study but geriatric complex therapy



Secondary Outcome Measures :
  1. Correlation and precision of camera-based heart rate measurement with reference data from standard patient monitor [ Time Frame: approx. 14 days (duration of geriatric complex therapy) ]

    the following devices / methods are used to record the heart rate:

    • camera-based measurement: photoplethysmography imaging (PPGI);
    • reference data: ECG

  2. Correlation and precision of camera-based heart rate variability with reference data from standard patient monitor [ Time Frame: approx. 14 days (duration of geriatric complex therapy) ]

    the following devices are used to record the heart rate variability:

    • camera-based measurement: photoplethysmography imaging (PPGI);
    • reference data: Pulsoximeter (fingerclip)

  3. Correlation and precision of camera-based respiratory rate with reference data from standard patient monitor [ Time Frame: approx. 14 days (duration of geriatric complex therapy) ]

    the following devices / methods are used to record the respiratory rate:

    • camera-based measurement: infrared thermography (IRT);
    • reference data: ECG

  4. Development of Frailty / geriatric assessment at the beginning and end of the geriatric early-rehabilitation complex-therapy [ Time Frame: approx. 14 days (duration of geriatric complex therapy) ]
    Frailty is evaluated by geriatric assessment (questionnaires)



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
10 patients above 70 years with frailty form the geriatric medicine ward in the Franziskushospital Aachen and 10 healthy volunteers with age above 70 years without frailty
Criteria

Inclusion Criteria:

  • Group 1: aged above 70 if they have typical geriatric multimorbidity, otherwise aged above 80, patient on the geriatric ward in the hospital "Franziskhospital Aachen"
  • Group 2 (Healthy volunteers): aged above 70, healthy and in good physical condition
  • Written informed consent by patient / volunteer

Exclusion Criteria:

  • Inability to consent
  • Pace maker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585985


Contacts
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Contact: Xinchi Yu, M.Sc. +49 241 8023228 yu@hia.rwth-aachen.de
Contact: Thea Laurentius, Dr. med. Dipl-Ing +49 241 7501631 tlaurentius@ukaachen.de

Locations
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Germany
Department of Geriatrics, University Hospital RWTH Aachen Aachen Recruiting
Aachen, North Rhine-Westphalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Cornelius Bollheimer, Univ.-Prof. Dr. med. Department of Geriatrics, University Hospital RWTH Aachen Aachen, NRW, Germany, 52074 Contacts:

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03585985     History of Changes
Other Study ID Numbers: 18-059
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Frailty
Pathologic Processes