FrailtyFORTO 2NCT05368337
Feasibility and Usability of Intrinsic Capacity Monitoring With Eforto and Its Predictive Value for Health Outcomes in Older Community-dwelling Persons
An observational study of Frailty, run by Vrije Universiteit Brussel.
Trial summary
In this study, 160 community-dwelling older adults (65 years and older) will be provided with an eforto® system to self-monitor their muscle fatigability and self-perceived fatigue for 2 consecutive days per week during 12 months (if needed with assistance by an informal caregiver). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2022to 31 Dec 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Community-dwelling older people aged 65 years and over.
Who may be able to join
- Aged 65 years and over
- Living in the community (independently at home or at home assisted by an informal caregiver or in assistive housing)
- Being able to operate the basic functions of a smartphone (if needed with assistance by an informal caregiver): using a smartphone at least for calls and minimum 1 other application
- Understanding Dutch or French
- Simple Frail Scale score <3
Who cannot join
- Being unable to participate in the assessments due to:
- Physical impairments (e.g. unable to stand up or walk)
- Cognitive impairments (unable to understand the test instructions and/or Mini Mental State Examination (MMSE) score <23/30)
- Functional disability of the dominant upper extremity (pare-sis/paralysis, tremor or recent surgery)
Trial locations and contacts
No sites are listed yet.
About this study
In this study, 160 community-dwelling older adults (65 years and older) will be provided with an eforto® system to self-monitor their muscle fatigability and self-perceived fatigue for 2 consecutive days per week during 12 months (if needed with assistance by an informal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.
The aims of the study are:
- to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the eforto® system in the home setting.
- to investigate if changes and variability in intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue), are related to changes in frailty status, functional independency and quality of life.
- to explore whether intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue) is related to circulating inflammatory biomarkers.
Read the detailed description
Investigational device:
The eforto® system was developed based on approximatively 20 years of scientific research on handgrip muscle fatigability performed by the Frailty in Ageing research department (see https://fria.research.vub.be/) and in collaboration with top-level international partners.
The eforto® system allows self-assessment of muscle fatigability and self-perceived fatigue in older adults and functions as a monitoring tool for intrinsic capacity. It is a small device, easy to use, and suitable for home measurements as well as hospital settings. When used correctly, the measurements cause no discomfort and can be performed repeatedly. The rubber bulb connects to a smartphone application that provides verbal test instructions to the participant. The app will guide the participant during the test and automatically provide motivational cues via audio. The test results are aggregated and stored in a cloud platform where the researcher can manage subjects, access the test data and export it for further analysis. The mobile app supports Dutch, French and English.
In a previous study, eforto® was clinically validated against a gold-standard pressure gauge in n=61 community-dwelling older adults, n=26 hospitalized geriatric patients and n=25 older hip fracture patients. Moreover, the usability and acceptance of eforto® self-monitoring (1 week) was demonstrated in a sample of n=30 community dwelling older persons aged between 83 and 95 years old. (paper submitted for publication in international peer-reviewed journal)
Procedures:
After the recruitment, a researcher will estimate whether the participant is eligible for the study during a eligibility check by a telephone call and legally capable to provide consent. After informed consent is given, baseline measurements will take place. These measurements will be reassessed after 6 months and 12 months. After an individual information session explaining how to use eforto®, the participant will be instructed to perform the eforto® measurements for 2 consecutive days per week for 12 months at home (if needed with assistance by an informal caregiver). Preferentially, the researcher will install the eforto® application on the smartphone of the participant. The home measurements will be continued for 12 months or until withdrawal of the participant. During the study, there will be a monthly telephone contact between participants and researchers in order to register technical problems, and self-reported changes in health situation.
- Conditions
- Frailty
- Keywords
- muscle fatigability, self-monitoring, prevention, self-perceived fatigue
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 1
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 2
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 3
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 4
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 5
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 6
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 7
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 8
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 9
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 10
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 11
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 12
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 13
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 14
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 15
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 16
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 17
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 18
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 19
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 20
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 21
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 22
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 23
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 24
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 25
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 26
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 27
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 28
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 29
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 30
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 31
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 32
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 33
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 34
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 35
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 36
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 37
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 38
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 39
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 40
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 41
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 42
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 43
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 44
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 45
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 46
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 47
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 48
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 49
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 50
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 51
Usability of the eforto® system
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Measured: Week 52
Feasibility of the eforto® system
An self-reported questionnaire (12 questions) based on the technology acceptance model (the Unified Theory of Acceptance Use of Technology (UTAUT)). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.
Measured: End of the study (week 52)
Secondary outcomes (24)
The correlation between muscle fatigability and frailty status.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The frailty status will be assessed by the frailty assessments: a) Fried Criteria: consists of five components: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity. This is operationalised through self-reported questions and non-invasive tests like grip strength using eforto® and timed 4-meter walking. Frailty is defined as having ≥3 of the 5 components, pre-frail participants have 1 or 2 components and robust participants have none of the components. b) Groningen Frailty Indicator: this is a 15-item self-reported questionnaire. Each positive answer is given a score of 1. A score of ≥4 indicates moderate to severe frailty.
Measured: Baseline
The correlation between self-perceived fatigue and frailty status.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The Multidimensional Fatigue Inventory will be assessed in the context of self-perceived fatigue. The frailty status will be assessed by a) Fried Criteria: consists of 5 components: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity. This is operationalised through self-reported questions and non-invasive tests. Frailty = having ≥3 of the 5 components, pre-frail = having 1 or 2 components and robust = having none of the components. b) Groningen Frailty Indicator: = 15-item self-reported questionnaire. Each positive answer is given a score of 1. A score of ≥4 indicates moderate to severe frailty.
Measured: Baseline
The correlation between muscle fatigability and frailty status.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The frailty status will be assessed by the frailty assessments: a) Fried Criteria: consists of five components: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity. This is operationalised through self-reported questions and non-invasive tests like grip strength using eforto® and timed 4-meter walking. Frailty is defined as having ≥3 of the 5 components, pre-frail participants have 1 or 2 components and robust participants have none of the components. b) Groningen Frailty Indicator: this is a 15-item self-reported questionnaire. Each positive answer is given a score of 1. A score of ≥4 indicates moderate to severe frailty.
Measured: 6 months
The correlation between self-perceived fatigue and frailty status.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The Multidimensional Fatigue Inventory will be assessed in the context of self-perceived fatigue. The frailty status will be assessed by a) Fried Criteria: consists of 5 components: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity. This is operationalised through self-reported questions and non-invasive tests. Frailty = having ≥3 of the 5 components, pre-frail = having 1 or 2 components and robust = having none of the components. b) Groningen Frailty Indicator: = 15-item self-reported questionnaire. Each positive answer is given a score of 1. A score of ≥4 indicates moderate to severe frailty.
Measured: 6 months
The correlation between muscle fatigability and frailty status.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The frailty status will be assessed by the frailty assessments: a) Fried Criteria: consists of five components: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity. This is operationalised through self-reported questions and non-invasive tests like grip strength using eforto® and timed 4-meter walking. Frailty is defined as having ≥3 of the 5 components, pre-frail participants have 1 or 2 components and robust participants have none of the components. b) Groningen Frailty Indicator: this is a 15-item self-reported questionnaire. Each positive answer is given a score of 1. A score of ≥4 indicates moderate to severe frailty.
Measured: 12 months
The correlation between self-perceived fatigue and frailty status.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The Multidimensional Fatigue Inventory will be assessed in the context of self-perceived fatigue. The frailty status will be assessed by a) Fried Criteria: consists of 5 components: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity. This is operationalised through self-reported questions and non-invasive tests. Frailty = having ≥3 of the 5 components, pre-frail = having 1 or 2 components and robust = having none of the components. b) Groningen Frailty Indicator: = 15-item self-reported questionnaire. Each positive answer is given a score of 1. A score of ≥4 indicates moderate to severe frailty.
Measured: 12 months
The correlation between muscle fatigability and functional independency.
Muscle fatigability will be measured with the eforto® system (grip work, expressed in kPa*s). The functional independency will be assessed by the Katz Basic Activities of Daily Living (range of score: 6-24; a low score = high function, independent and a high score = low function, dependent) and the Lawton Instrumental Activities of Daily Living Scale (range of score: 9-27; a low score = low function, dependent and a high score = high function, independent).
Measured: At baseline
The correlation between self-perceived fatigue and functional independency.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The functional independency will be assessed by the Katz Basic Activities of Daily Living (range of score: 6-24; a low score = high function, independent and a high score = low function, dependent) and the Lawton Instrumental Activities of Daily Living Scale (range of score: 9-27; a low score = low function, dependent and a high score = high function, independent).
Measured: At baseline
The correlation between muscle fatigability and functional independency.
Muscle fatigability will be measured with the eforto® system (grip work, expressed in kPa*s). The functional independency will be assessed by the Katz Basic Activities of Daily Living (range of score: 6-24; a low score = high function, independent and a high score = low function, dependent) and the Lawton Instrumental Activities of Daily Living Scale (range of score: 9-27; a low score = low function, dependent and a high score = high function, independent).
Measured: 6 months
The correlation between self-perceived fatigue and functional independency.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The functional independency will be assessed by the Katz Basic Activities of Daily Living (range of score: 6-24; a low score = high function, independent and a high score = low function, dependent) and the Lawton Instrumental Activities of Daily Living Scale (range of score: 9-27; a low score = low function, dependent and a high score = high function, independent).
Measured: 6 months
The correlation between muscle fatigability and functional independency.
Muscle fatigability will be measured with the eforto® system (grip work, expressed in kPa*s). The functional independency will be assessed by the Katz Basic Activities of Daily Living (range of score: 6-24; a low score = high function, independent and a high score = low function, dependent) and the Lawton Instrumental Activities of Daily Living Scale (range of score: 9-27; a low score = low function, dependent and a high score = high function, independent).
Measured: 12 months
The correlation between self-perceived fatigue and functional independency.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The functional independency will be assessed by the Katz Basic Activities of Daily Living (range of score: 6-24; a low score = high function, independent and a high score = low function, dependent) and the Lawton Instrumental Activities of Daily Living Scale (range of score: 9-27; a low score = low function, dependent and a high score = high function, independent).
Measured: 12 months
The correlation between muscle fatigability and quality of life.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The quality of life will be assessed by the self-reported questionnaires SarQol (short form), Eq-5D-5L, and Brief Resilience Scale.
Measured: At baseline
The correlation between self-perceived fatigue and quality of life.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The quality of life will be assessed by the self-reported questionnaires SarQol (short form), Eq-5D-5L, and Brief Resilience Scale.
Measured: At baseline
The correlation between muscle fatigability and quality of life.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The quality of life will be assessed by the self-reported questionnaires SarQol (short form), Eq-5D-5L, and Brief Resilience Scale.
Measured: 6 months
The correlation between self-perceived fatigue and quality of life.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The quality of life will be assessed by the self-reported questionnaires SarQol (short form), Eq-5D-5L, and Brief Resilience Scale.
Measured: 6 months
The correlation between muscle fatigability and quality of life.
Muscle fatigability will be measured with the eforto® system (grip work, kPa). The quality of life will be assessed by the self-reported questionnaires SarQol (short form), Eq-5D-5L, and Brief Resilience Scale.
Measured: 12 months
The correlation between self-perceived fatigue and quality of life.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The quality of life will be assessed by the self-reported questionnaires SarQol (short form), Eq-5D-5L, and Brief Resilience Scale.
Measured: 12 months
The correlation between muscle fatigability and circulating inflammatory biomarkers.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The circulating inflammatory biomarkers will be measured by blood sampling:
- 1x 3mL serum for determination of hsCRP.
- Additional 1x 9mL EDTA and 1x 9mL serum tube will be obtained for determination of inflammation-related cyto/chemokines including IL1RA, IL6, IL10, TNFα, MCP1, suPAR and sRAGE.
Measured: At baseline
The correlation between muscle fatigability and circulating inflammatory biomarkers.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The circulating inflammatory biomarkers will be measured by blood sampling:
- 1x 3mL serum for determination of hsCRP.
- Additional 1x 9mL EDTA and 1x 9mL serum tube will be obtained for determination of inflammation-related cyto/chemokines including IL1RA, IL6, IL10, TNFα, MCP1, suPAR and sRAGE.
Measured: 6 months
The correlation between muscle fatigability and circulating inflammatory biomarkers.
Muscle fatigability will be measured with the eforto® system (grip work, kPa*s). The circulating inflammatory biomarkers will be measured by blood sampling:
- 1x 3mL serum for determination of hsCRP.
- Additional 1x 9mL EDTA and 1x 9mL serum tube will be obtained for determination of inflammation-related cyto/chemokines including IL1RA, IL6, IL10, TNFα, MCP1, suPAR and sRAGE.
Measured: 12 months
The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The circulating inflammatory biomarkers will be measured by blood sampling:
- 1x 3mL serum for determination of hsCRP.
- Additional 1x 9mL EDTA and 1x 9mL serum tube will be obtained for determination of inflammation-related cyto/chemokines including IL1RA, IL6, IL10, TNFα, MCP1, suPAR and sRAGE.
Measured: At baseline
The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The circulating inflammatory biomarkers will be measured by blood sampling:
- 1x 3mL serum for determination of hsCRP.
- Additional 1x 9mL EDTA and 1x 9mL serum tube will be obtained for determination of inflammation-related cyto/chemokines including IL1RA, IL6, IL10, TNFα, MCP1, suPAR and sRAGE.
Measured: 6 months
The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
Self-perceived fatigue will be measured with the eforto® system (2 self-perceived fatigue questions: Question 1: How fatigued are you feeling at this moment? Options for answer: 1-7. 1 is 'not tired', 7 is 'extremely tired'. Question 2: I fatigue quickly. Options for answer: 1-7. 1 is 'No, I don't agree', 7 is 'Yes, I agree'). The participants will also complete the Multidimensional Fatigue Inventory in the context of self-perceived fatigue (also embedded in the eforto® system). The circulating inflammatory biomarkers will be measured by blood sampling:
- 1x 3mL serum for determination of hsCRP.
- Additional 1x 9mL EDTA and 1x 9mL serum tube will be obtained for determination of inflammation-related cyto/chemokines including IL1RA, IL6, IL10, TNFα, MCP1, suPAR and sRAGE.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start30 May 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, INNOVIRIS, AAL
- Responsible party
- Principal investigator, Prof. Ivan Bautmans, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368337
- Sponsor's protocol ID
- FORTO 2.0
- Acronym
- FORTO 2
- Status last verified
- May 2022
- First submitted
- 22 Feb 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rasmussen LJH, Caspi A, Ambler A, Danese A, Elliott M, Eugen-Olsen J, Hariri AR, Harrington H, Houts R, Poulton R, Ramrakha S, Sugden K, Williams B, Moffitt TE. Association Between Elevated suPAR, a New Biomarker of Inflammation, and Accelerated Aging. J Gerontol A Biol Sci Med Sci. 2021 Jan 18;76(2):318-327. doi: 10.1093/gerona/glaa178.
PubMed 32766674Frimat M, Teissier T, Boulanger E. Is RAGE the receptor for inflammaging? Aging (Albany NY). 2019 Sep 8;11(17):6620-6621. doi: 10.18632/aging.102256. Epub 2019 Sep 8. No abstract available.
PubMed 31494645Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Bautmans I, Mets T. A fatigue resistance test for elderly persons based on grip strength: reliability and comparison with healthy young subjects. Aging Clin Exp Res. 2005 Jun;17(3):217-22. doi: 10.1007/BF03324600.
PubMed 16110735KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
PubMed 14044222Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PubMed 5349366Beaudart C, Biver E, Reginster JY, Rizzoli R, Rolland Y, Bautmans I, Petermans J, Gillain S, Buckinx F, Dardenne N, Bruyere O. Validation of the SarQoL(R), a specific health-related quality of life questionnaire for Sarcopenia. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):238-244. doi: 10.1002/jcsm.12149. Epub 2016 Oct 22.
PubMed 27897430Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PubMed 21479777Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PubMed 18696313van Hooff ML, Geurts SA, Kompier MA, Taris TW. "How fatigued do you currently feel?" Convergent and discriminant validity of a single-item fatigue measure. J Occup Health. 2007 May;49(3):224-34. doi: 10.1539/joh.49.224.
PubMed 17575403Alberts M, Smets EM, Vercoulen JH, Garssen B, Bleijenberg G. ['Abbreviated fatigue questionnaire': a practical tool in the classification of fatigue]. Ned Tijdschr Geneeskd. 1997 Aug 2;141(31):1526-30. Dutch.
PubMed 9543741
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Usability of Intrinsic Capacity Monitoring With Eforto and Its Predictive Value for Health Outcomes in Older Community-dwelling Persons
- ClinicalTrials.gov ID
- NCT05368337
- Acronym / sponsor ID
- FORTO 2 / FORTO 2.0
- Conditions
- Frailty
- Keywords
- muscle fatigability, self-monitoring, prevention, self-perceived fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel, INNOVIRIS, AAL
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 May 2022 (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.
In this study, 160 community-dwelling older adults (65 years and older) will be provided with an eforto® system to self-monitor their muscle fatigability and self-perceived fatigue for 2 consecutive days per week during 12 months (if needed with assistance by an informal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.
The aims of the study are:
- to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the eforto® system in the home setting.
- to investigate if changes and variability in intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue), are related to changes in frailty status, functional independency and quality of life.
- to explore whether intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue) is related to circulating inflammatory biomarkers.
Detailed description
Investigational device:
The eforto® system was developed based on approximatively 20 years of scientific research on handgrip muscle fatigability performed by the Frailty in Ageing research department (see https://fria.research.vub.be/) and in collaboration with top-level international partners.
The eforto® system allows self-assessment of muscle fatigability and self-perceived fatigue in older adults and functions as a monitoring tool for intrinsic capacity. It is a small device, easy to use, and suitable for home measurements as well as hospital settings. When used correctly, the measurements cause no discomfort and can be performed repeatedly. The rubber bulb connects to a smartphone application that provides verbal test instructions to the participant. The app will guide the participant during the test and automatically provide motivational cues via audio. The test results are aggregated and stored in a cloud platform where the researcher can manage subjects, access the test data and export it for further analysis. The mobile app supports Dutch, French and English.
In a previous study, eforto® was clinically validated against a gold-standard pressure gauge in n=61 community-dwelling older adults, n=26 hospitalized geriatric patients and n=25 older hip fracture patients. Moreover, the usability and acceptance of eforto® self-monitoring (1 week) was demonstrated in a sample of n=30 community dwelling older persons aged between 83 and 95 years old. (paper submitted for publication in international peer-reviewed journal)
Procedures:
After the recruitment, a researcher will estimate whether the participant is eligible for the study during a eligibility check by a telephone call and legally capable to provide consent. After informed consent is given, baseline measurements will take place. These measurements will be reassessed after 6 months and 12 months. After an individual information session explaining how to use eforto®, the participant will be instructed to perform the eforto® measurements for 2 consecutive days per week for 12 months at home (if needed with assistance by an informal caregiver). Preferentially, the researcher will install the eforto® application on the smartphone of the participant. The home measurements will be continued for 12 months or until withdrawal of the participant. During the study, there will be a monthly telephone contact between participants and researchers in order to register technical problems, and self-reported changes in health situation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older people aged 65 years and over.
Key inclusion criteria (5 listed)
- Aged 65 years and over
- Living in the community (independently at home or at home assisted by an informal caregiver or in assistive housing)
- Being able to operate the basic functions of a smartphone (if needed with assistance by an informal caregiver): using a smartphone at least for calls and minimum 1 other application
- Understanding Dutch or French
- Simple Frail Scale score <3
Key exclusion criteria (4 listed)
- Physical impairments (e.g. unable to stand up or walk)
- Cognitive impairments (unable to understand the test instructions and/or Mini Mental State Examination (MMSE) score <23/30)
- Functional disability of the dominant upper extremity (pare-sis/paralysis, tremor or recent surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability of the eforto® system
Time frame: Week 1
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 2
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 3
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 4
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 5
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 6
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 7
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 8
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 9
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 10
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 11
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 12
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 13
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 14
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 15
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 16
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 17
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 18
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 19
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 20
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 21
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 22
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 23
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 24
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 25
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 26
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 27
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 28
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 29
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 30
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 31
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 32
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 33
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 34
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 35
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 36
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 37
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 38
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 39
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 40
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 41
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 42
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 43
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 44
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 45
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 46
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 47
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 48
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 49
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 50
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 51
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Usability of the eforto® system
Time frame: Week 52
A checklist of potential technical problems (11 questions) related to the eforto® system that can occur during the study. Options for answer: yes or no; if 'yes' => clarify the technical problem.
Feasibility of the eforto® system
Time frame: End of the study (week 52)
An self-reported questionnaire (12 questions) based on the technology acceptance model (the Unified Theory of Acceptance Use of Technology (UTAUT)). Options for answer: 1-5. 1 is 'Strongly disagree', 5 is 'Strongly agree'.
24 secondary outcomes
The correlation between muscle fatigability and frailty status.
Time frame: Baseline
The correlation between self-perceived fatigue and frailty status.
Time frame: Baseline
The correlation between muscle fatigability and frailty status.
Time frame: 6 months
The correlation between self-perceived fatigue and frailty status.
Time frame: 6 months
The correlation between muscle fatigability and frailty status.
Time frame: 12 months
The correlation between self-perceived fatigue and frailty status.
Time frame: 12 months
The correlation between muscle fatigability and functional independency.
Time frame: At baseline
The correlation between self-perceived fatigue and functional independency.
Time frame: At baseline
The correlation between muscle fatigability and functional independency.
Time frame: 6 months
The correlation between self-perceived fatigue and functional independency.
Time frame: 6 months
The correlation between muscle fatigability and functional independency.
Time frame: 12 months
The correlation between self-perceived fatigue and functional independency.
Time frame: 12 months
The correlation between muscle fatigability and quality of life.
Time frame: At baseline
The correlation between self-perceived fatigue and quality of life.
Time frame: At baseline
The correlation between muscle fatigability and quality of life.
Time frame: 6 months
The correlation between self-perceived fatigue and quality of life.
Time frame: 6 months
The correlation between muscle fatigability and quality of life.
Time frame: 12 months
The correlation between self-perceived fatigue and quality of life.
Time frame: 12 months
The correlation between muscle fatigability and circulating inflammatory biomarkers.
Time frame: At baseline
The correlation between muscle fatigability and circulating inflammatory biomarkers.
Time frame: 6 months
The correlation between muscle fatigability and circulating inflammatory biomarkers.
Time frame: 12 months
The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
Time frame: At baseline
The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
Time frame: 6 months
The correlation between self-perceived fatigue and circulating inflammatory biomarkers.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 32766674Rasmussen LJH, Caspi A, Ambler A, Danese A, Elliott M, Eugen-Olsen J, Hariri AR, Harrington H, Houts R, Poulton R, Ramrakha S, Sugden K, Williams B, Moffitt TE. Association Between Elevated suPAR, a New Biomarker of Inflammation, and Accelerated Aging. J Gerontol A Biol Sci Med Sci. 2021 Jan 18;76(2):318-327. doi: 10.1093/gerona/glaa178.
- Background: PubMed 31494645Frimat M, Teissier T, Boulanger E. Is RAGE the receptor for inflammaging? Aging (Albany NY). 2019 Sep 8;11(17):6620-6621. doi: 10.18632/aging.102256. Epub 2019 Sep 8. No abstract available.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 16110735Bautmans I, Mets T. A fatigue resistance test for elderly persons based on grip strength: reliability and comparison with healthy young subjects. Aging Clin Exp Res. 2005 Jun;17(3):217-22. doi: 10.1007/BF03324600.
- Background: PubMed 14044222KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
- Background: PubMed 5349366Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
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- Background: PubMed 21479777Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Background: PubMed 18696313Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
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- FORTO-aal siteLink provided by the sponsor.
- Frailty in ageing research group VUB siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty, run by Vrije Universiteit Brussel.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Bautmans, Prof Dr (+32 (0)2 477 42 07, ivan.bautmans@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the eforto® system (time frame: Week 1). The study lists 53 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05368337, which also lists 11 linked publications.
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 10 May 2022.