Clinical trial NCT03585985: Investigation of a Link Between Heart Rate Variability and Frailty in Geriatric Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fragility
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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).

Eligibility 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

Primary outcomes:
measure: Link between heart rate variability and frailty
timeFrame: approx. 14 days (duration of geriatric complex therapy)
Secondary outcomes:
measure: Correlation and precision of camera-based heart rate measurement with reference data from standard patient monitor
timeFrame: approx. 14 days (duration of geriatric complex therapy)
measure: Correlation and precision of camera-based heart rate variability with reference data from standard patient monitor
timeFrame: approx. 14 days (duration of geriatric complex therapy)
measure: Correlation and precision of camera-based respiratory rate with reference data from standard patient monitor
timeFrame: approx. 14 days (duration of geriatric complex therapy)
measure: Development of Frailty / geriatric assessment at the beginning and end of the geriatric early-rehabilitation complex-therapy
timeFrame: approx. 14 days (duration of geriatric complex therapy)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Geriatrics, University Hospital RWTH Aachen Aachen
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Geriatrics, University Hospital RWTH Aachen Aachen, NRW, Germany, 52074 Contacts:
name: Cornelius Bollheimer, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: