Feasibility and Usability of Intrinsic Capacity Monitoring With Eforto and Its Predictive Value for Health Outcomes in Older Community-dwelling Persons (FORTO 2)

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:

1. to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the eforto® system in the home setting.
2. 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.
3. to explore whether intrinsic capacity as measured with eforto® (muscle fatigability and self-perceived fatigue) is related to circulating inflammatory biomarkers.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Ivan Bautmans, Prof Dr; Phone Number: +32 (0)2 477 42 07; Email: ivan.bautmans@vub.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling older people aged 65 years and over.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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'.	End of the study (week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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).	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).	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).	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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: Universitair Ziekenhuis Brussel; INNOVIRIS; AAL

Publications and helpful links

General Publications

• Fried 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.
• Herdman 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.
• Smith 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.
• KATZ 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.
• Lawton 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.
• 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.
• Frimat 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.
• Bautmans 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.
• Beaudart 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.
• van 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.
• Alberts 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.

Helpful Links

• FORTO-aal site
• Frailty in ageing research group VUB site

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: prevention; self-monitoring; muscle fatigability; self-perceived fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: FORTO 2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No