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

NCT03585985 | Completed

• 1 other identifier: 18-059
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Fragility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation and precision of camera-based heart rate measurement with reference data from standard patient monitor

  approx. 14 days (duration of geriatric complex therapy)

• Correlation and precision of camera-based heart rate variability with reference data from standard patient monitor

  approx. 14 days (duration of geriatric complex therapy)

• Correlation and precision of camera-based respiratory rate with reference data from standard patient monitor

  approx. 14 days (duration of geriatric complex therapy)

• Development of Frailty / geriatric assessment at the beginning and end of the geriatric early-rehabilitation complex-therapy

  approx. 14 days (duration of geriatric complex therapy)

Study Arms (2)

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; Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)

Group 2

10 healthy elderly people above 70 years, healthy

Procedure: Standard patient monitor; Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)

Interventions

Standard patient monitor PROCEDURE

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

Group 1; Group 2

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)

Group 1; Group 2

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Inability to consent
• Pace maker

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Geriatrics, University Hospital RWTH Aachen Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Study Officials

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

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: July 13, 2018
• Study Start: July 1, 2018
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

DE (1)