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Completed

NCT Number: NCT03585985

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

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.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Geriatrics, University Hospital RWTH Aachen Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard patient monitor

Procedure

Measurement of reference data: heart rate, heart rate variability and respiratory rate

Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)

Procedure

Camera-based technology for the determination of heart rate variability (PPGI) and contactless measurement of breathing rate (IRT)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 13, 2018
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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