FragilityNCT03585985
Investigation of a Link Between Heart Rate Variability and Frailty in Geriatric Patients
An observational study of Fragility, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fragility
- What is being tested?
- Standard patient monitor and Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 12 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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
Who may be able to join
- 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
Who cannot join
- Inability to consent
- Pace maker
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Geriatrics, University Hospital RWTH Aachen Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
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
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.
Read the 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
- Being tested
- Standard patient monitor, Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard patient monitorProcedure or surgery
Measurement of reference data: heart rate, heart rate variability and respiratory rate
Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)Procedure or surgery
Camera-based technology for the determination of heart rate variability (PPGI) and contactless measurement of breathing rate (IRT)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Standard patient monitor; Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT) | |
| Group 2 | 10 healthy elderly people above 70 years, healthy Receives: Procedure: Standard patient monitor; Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
the following devices / methods are used to record the heart rate:
- camera-based measurement: photoplethysmography imaging (PPGI);
- reference data: ECG
Measured: approx. 14 days (duration of geriatric complex therapy)
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)
Measured: approx. 14 days (duration of geriatric complex therapy)
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
Measured: 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
Frailty is evaluated by geriatric assessment (questionnaires)
Measured: approx. 14 days (duration of geriatric complex therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start1 Jul 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FragilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cornelius Bollheimer, Univ.-Prof. Dr. med., Principal investigator, Department of Geriatrics, University Hospital RWTH Aachen Aachen, NRW, Germany, 52074 Contacts:
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585985
- Sponsor's protocol ID
- 18-059
- Status last verified
- Sep 2019
- First submitted
- 24 May 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03585985
- Acronym / sponsor ID
- 18-059
- Conditions
- Fragility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 13 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Standard patient monitor, Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)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 |
| Group 2 | – | Procedure: Standard patient monitor, Procedure: Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)10 healthy elderly people above 70 years, healthy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to consent
- Pace maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard patient monitorMeasurement of reference data: heart rate, heart rate variability and respiratory rate | Procedure or surgery | Group 1, Group 2 |
| Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)Camera-based technology for the determination of heart rate variability (PPGI) and contactless measurement of breathing rate (IRT) | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelius Bollheimer, Univ.-Prof. Dr. med. principal investigator
Department of Geriatrics, University Hospital RWTH Aachen Aachen, NRW, Germany, 52074 Contacts:
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fragility, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Link between heart rate variability and frailty (time frame: approx. 14 days (duration of geriatric complex therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.