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

Fragility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585985
• Other study ID #: 18-059
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: April 12, 2019

Study information

• Verified date: September 2019
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fragility
• Frailty

Intervention

Procedure:
• Standard patient monitor
Measurement of reference data: heart rate, heart rate variability and respiratory rate
• Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)
Camera-based technology for the determination of heart rate variability (PPGI) and contactless measurement of breathing rate (IRT)

Locations

Country	Name	City	State
Germany	Department of Geriatrics, University Hospital RWTH Aachen Aachen	Aachen	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Link between heart rate variability and frailty	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	approx. 14 days (duration of geriatric complex therapy)
Secondary	Correlation and precision of camera-based heart rate measurement with reference data from standard patient monitor	the following devices / methods are used to record the heart rate: camera-based measurement: photoplethysmography imaging (PPGI); reference data: ECG	approx. 14 days (duration of geriatric complex therapy)
Secondary	Correlation and precision of camera-based heart rate variability with reference data from standard patient monitor	the following devices are used to record the heart rate variability: camera-based measurement: photoplethysmography imaging (PPGI); reference data: Pulsoximeter (fingerclip)	approx. 14 days (duration of geriatric complex therapy)
Secondary	Correlation and precision of camera-based respiratory rate with reference data from standard patient monitor	the following devices / methods are used to record the respiratory rate: camera-based measurement: infrared thermography (IRT); reference data: ECG	approx. 14 days (duration of geriatric complex therapy)
Secondary	Development of Frailty / geriatric assessment at the beginning and end of the geriatric early-rehabilitation complex-therapy	Frailty is evaluated by geriatric assessment (questionnaires)	approx. 14 days (duration of geriatric complex therapy)