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

NCT ID: NCT03585985

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-04-12

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).

Conditions

Fragility

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Standard patient monitor

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

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

Standard patient monitor

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

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

Interventions

Standard patient monitor

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

Intervention Type: 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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelius Bollheimer, Univ.-Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Geriatrics, University Hospital RWTH Aachen Aachen, NRW, Germany, 52074 Contacts:

Locations

Department of Geriatrics, University Hospital RWTH Aachen Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

18-059

Identifier Type: -

Identifier Source: org_study_id