The Inspire Bio-resource Research Platform for Healthy Aging INSPIRE Platform (INSPIRE)

The Inspire Bio-resource Research Platform for Healthy Aging

Since aging is a systemic (not organ-specific) phenomenon, the main objective of Inspire Bio-resource Research Platform for Healthy Aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and IC evolution. The Inspire Platform will gather data and biospecimens from subjects of different ages (from 30 years or over - no upper limit for age) and functional capacity levels (from robust to frail to disabled) over 10 years.

Study Overview

• Status: Recruiting
• Conditions: Biological Aging
• Intervention / Treatment: Other: The Inspire Bio-resource Research Platform for Healthy Aging

Detailed Description

This is a 10-year observational study. The study will be performed in Occitania Region. Once a year, a complete data collection will be performed in the Gerontopole of Toulouse, in participants' home and health centers by the Gerontopole mobile research team, and in selected Gerontopole's collaborating centers in Occitania.

Between yearly waves of data collection, participants will have their intrinsic capacity domains monitored (with or without the help of a caregiver) each 4-month through the use of either an app developed in collaboration with World Health Organization (WHO) or a web platform; or through a phone call by a clinical/research nurse. For the first self-monitoring of IC at four months, all participants will be contacted by a research/clinical nurse by phone; this call will inform about how participants measured their capacity and/or help them to do it. After this first 4-month phone call, participants capable of correctly self-monitoring their IC through the app will no longer be systematically contacted by phone. Once IC declines are confirmed, participants will have a thorough clinical assessment and blood sampling; such information will allow us to investigate the response of markers of aging at the time declines are detected. Those needing usual care, will be followed according to WHO framework recommendations proposed for Integrated Care for Older Adults (ICOPE).

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Bruno VELLAS, MD; Phone Number: +33 5 61 77 70 47; Email: vellas.b@chu-toulouse.fr
• Study Contact Backup: Name: Sophie GUYONNET, PhD; Phone Number: +33 5 61 77 70 43; Email: guyonnet.s@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital Toulouse
    • Contact: Bruno Vellas, MD; Phone Number: 33 05.61.77.70.47; Email: vellas.b@chu-toulouse.fr
    • Contact: Sophie Guyonnet; Phone Number: 33 5 61 77 70 43; Email: guyonnet.s@chu-toulouse.fr
    • Principal Investigator: Pierre Jean Ousset, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Recruitment will be stratified per 10-year age groups, oversampling older people in order to be able to investigate major clinical events (eg, declines on IC, onset of age-related diseases)

Description

Inclusion Criteria:

• Aged 30 years-old or over;
• Both sexes
• Affiliated to a social security scheme

Exclusion Criteria:

• severe disease compromising life expectancy at 5 years;
• Deprived of their liberty by administrative or judicial decision, or under guardianship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data collection of key variables and biospecimens	The main outcome of Inspire Bio-resource Research Platform for Healthy Aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and intrinsic capacities (cognition, mobility, nutrition, hearing and visual capacities, psychological capacity) evolution. The Inspire Platform will gather data and biospecimens from subjects of different ages (from 30 years or over - no upper limit for age) and functional capacity levels (from robust to frail to disabled) over 10 years.	through study completion, an average of 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of (a set of) biomarkers of aging through the constitution of a comprehensive biobank comprising: blood, saliva, urine, nasopharyngeal swabbing, skin biopsies and surface samples, dental plaque, faeces, hair bulb.	1. Markers of aging: The identification of (a set of) markers of aging will be allowed from the constitution of a large dataset of clinical, para-clinical and digital data as well as a comprehensive biobank comprising: blood, saliva, urine, nasopharyngeal swabbing, skin material (swabbing, stripping, biopsies), dental plaque, feces, hair bulb. In this part of the study, we will take advantage of three complimentary approaches to look for the best markers of aging: without a priori approach (omics: transcriptomics, proteomics, lipidomics); semi a priori approach (field-specific omic. I.e. metabolism, inflammation, cell cycle, mitochondrial network…); and targeted approach (pre-identified targets).	through study completion, an average of 10 years
measure intrinsic capacity domains with questionnaire in ICOPE App (developed in collaboration with W.H.O.)	Icope app (developed in collaboration with W.H.O.) for smartphone and tablet to measure intrinsic capacity domains. This app will be used for the remote (at-distance) evaluation and monitoring (self-monitoring, monitoring by a caregiver, or a healthcare provider) of intrinsic capacity domains; for the monitoring, we will use only the Icope Step 1. When declines are detected in the Icope Step 1, we will use the Icope Step 2 (data collected by research nurses in a home visit or at the research facility) to confirm the decline and, then, look for the causes determining such declines.	through study completion, an average of 10 years
Basic and instrumental activities of daily living.	Basic and instrumental activities of daily living (ADL). Basic ADLs will be assessed using the 6-item (eg, bathing, feeding, dressing) Katz scale; instrumental ADLs (IADL) will be assessed using the 8-item (eg, cooking, manipulating money) Lawton scale. These variables are measured as a clinical measurement of functional ability and, thus, healthy aging in late ages, according to WHO definition.	through study completion, an average of 10 years
Mini-nutritional assessment and food frequency questionnaire.	Mini-nutritional assessment (MNA) and food frequency questionnaire. Nutritional status will be evaluated using the MNA (see Vitality description in Icope Step 2). A short (12-item; the question on physical activity has been removed since already investigated using other assessment tools in this project) food frequency questionnaire will be used to assess dietary quality. Nutritional status and diet may affect both intrinsic capacity domains and potential biomarkers of aging.	through study completion, an average of 10 years
Lifestyle questionnaires	. Lifestyle questionnaires: Physical activity (PA) and sedentary time: Based on the International Physical Activity Questionnaire (IPAQ) long form.; Smoking: This will be evaluated by two questions: Do you currently smoke: any tobacco product? ; e-cigarettes? Responses will be anchored by the terms: daily; weekly, but not daily; less often than weekly; not at all.; Alcohol consumption: This will be evaluated by a question of the food frequency questionnaire; Solar exposure: Sun Protection and Exposure Habits Questionnaires	through study completion, an average of 10 years
ActivPAL: objectively physical activity parameters.	Objectively measured physical activity (PA) and sleep parameters. This will be assessed with an activPal activity monitor. Participants will wear the activPal for one week every two-years and will bring it back personally to the research facilities. Attention will be paid for participants wearing the activity monitor always during the same season to avoid bias related to seasonal changes. PA is one of the most important behaviors for healthy aging, being associated with both intrinsic capacity domains and biomarkers. Sleep changes are often associated with aging and may affect healthy aging.	through study completion, an average of 10 years
Self-reported visceral pain.	Visceral pain. This will be assessed with a 4-item self-reported questionnaire. This questionnaire is particularly important for investigations on biomarkers from feces.	through study completion, an average of 10 years
Participant-reported outcome for cognition (CFI)	Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"	through study completion, an average of 10 years
Participant-reported outcome for mobility	Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"	through study completion, an average of 10 years
Participant-reported outcome for fatigue	Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"	through study completion, an average of 10 years
Participant-reported outcome for social isolation (PROMIS)	Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"	through study completion, an average of 10 years
Participant-reported outcome for SARQoL.	Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"	through study completion, an average of 10 years
Participant-reported outcome for cognition (CFI) and mobility, fatigue, and social isolation (PROMIS), and SARQoL.	Patient reported outcome measures (PROM). Four PROMs, covering cognition and mobility (the two functions that largely determine disability and increased healthcare costs), the overall feeling of fatigue and social isolation. All of them are validated tools for cognition, we will use the Cognitive Function Instrument (CFI), a 14-item questionnaire with score varying from 0 to 14, higher is worse. All the other three PROMs come from the NIH-funded initiative "Patient-reported outcomes measurement information system"	through study completion, an average of 10 years
Oral Health Assessment Tool (OHAT).	Oral Health Assessment Tool (OHAT) provides a global overview of oral health. It is composed of 8 items: lips, tongue, gum-mucosa, saliva, natural teeth, prostheses, oral hygiene and pain. Each item is scored 0, 1 or 2. A score of 0 indicates the absence of degradation, a score of 2 indicates a significant presence of degradation, a score of 1 indicates that there is a remarkable modification without a significant or widespread degradation. The minimum score is 0 (satisfactory oral status) and the maximum score is 16 (degraded oral status).	through study completion, an average of 10 years
Short physical performance battery and 30-sec chair rise test.	Short physical performance battery (SPPB) and 30-sec chair rise test. The SPPB will be evaluated. With the participants' consent, performance in the SPPB tests will be video-recorded using standard cameras placed in three different angles in the room: the images will be analyzed to look for digital markers of aging through the patterns of motor function and subsequent subjects risk-stratification. The number of chair rises within 30secwill also be assessed in a fraction of participants. These measurements provide clinical information about mobility.	through study completion, an average of 10 years
The mini-mental state examination (MMSE)	The Mini-mental state examination (MMSE) and neuropsychological tests. The MMSE is a scale that provides total scores ranging from 0 to 30 (higher values represent better cognitive function). Besides the MMSE, in subjects less than 70 years-old the following neuropsychological tests will be used: free and total recall of the Free and Cued Selective Reminding Test, the Digit Symbol Substitution Test, score from the Wechsler Adult Intelligence Scale-Revised, and the Category Naming Test (2-minute category fluency in animals); when combined in a composite Z-score, these variables provide accurate information about participants' cognitive function.	through study completion, an average of 10 years
neuropsychological tests.	The Mini-mental state examination (MMSE) and neuropsychological tests. The MMSE is a scale that provides total scores ranging from 0 to 30 (higher values represent better cognitive function). Besides the MMSE, in subjects less than 70 years-old the following neuropsychological tests will be used: free and total recall of the Free and Cued Selective Reminding Test, the Digit Symbol Substitution Test, score from the Wechsler Adult Intelligence Scale-Revised, and the Category Naming Test (2-minute category fluency in animals); when combined in a composite Z-score, these variables provide accurate information about participants' cognitive function.	through study completion, an average of 10 years
Skin elasticity (cutometer measurement)	Skin elasticity (cutometer measurement). This measures the bio-mechanical properties of the skin by applying mechanical stress to the skin. The measuring principle is based on suction and elongation. A device will be used to generate a negative pressure which can vary between 20 and 500 mbar. The area of the skin to be measured is drawn into the probe opening by this pressure. The depth of skin penetration inside the probe opening is determined by an optical measurement system. The stress can be exerted at different depths of the skin: the 2mm probe solicits the skin at the superficial dermis; the 6mm probe engages the skin more deeply, at the level of the deep dermis, at the limit of the hypodermis.	through study completion, an average of 10 years
Dual Energy X-ray absorptiometry	Whole body magnetic resonance to measure the Isokinetic muscle strength with Dual Energy X-ray absorptiometry (DEXA°	through study completion, an average of 10 years
maximum oxygen consumption	maximum oxygen consumption (VO²max) and aerobic power (blood sampling before and after the effort).	through study completion, an average of 10 years

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: European Regional Development Fund
• Investigators: Principal Investigator: Bruno VELLAS, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Estimated): October 16, 2031
• Study Completion (Estimated): October 31, 2033

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Geroscience; biological aging and identifying targetable biomarkers; The Inspire Bio-resource Research Platform for Healthy Aging; Aged 30 years-old or over; age-related chronic diseases
• Other Study ID Numbers: RC31/19/0236

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