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Идёт набор NCT04224038

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

Наблюдательное Biological Aging

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The Inspire Bio-resource Research Platform for Healthy Aging.
Кому может быть актуально
Состояния в реестре: Biological Aging. Базовые параметры: от 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Inspire Bio-resource Research Platform for Healthy Aging

Обзор

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.

Подробное описание

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).

Вмешательства

  • Другое The Inspire Bio-resource Research Platform for Healthy Aging
    Several follow-up visits will be undertaken during the 10-year time frame of this project. Some of these visits are not regularly scheduled and will be conditioned by the remote monitoring of intrinsic capacity (IC) and the onset of other major clinical conditions. Other visits correspond to the regularly scheduled (yearly or every two years (biannual visits), depending on the outcome measures) waves of data collection.

Первичные конечные точки

  • Data collection of key variables and biospecimens [Срок оценки: through study completion, an average of 10 years]
Вторичные конечные точки (12)
  • 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. [Срок оценки: through study completion, an average of 10 years]
  • measure intrinsic capacity domains with questionnaire in ICOPE App (developed in collaboration with W.H.O.) [Срок оценки: through study completion, an average of 10 years]
  • Basic and instrumental activities of daily living. [Срок оценки: through study completion, an average of 10 years]
  • Mini-nutritional assessment and food frequency questionnaire. [Срок оценки: through study completion, an average of 10 years]
  • Lifestyle questionnaires [Срок оценки: through study completion, an average of 10 years]
  • ActivPAL: objectively physical activity parameters. [Срок оценки: through study completion, an average of 10 years]
  • Self-reported visceral pain. [Срок оценки: through study completion, an average of 10 years]
  • Participant-reported outcome for cognition (CFI) [Срок оценки: through study completion, an average of 10 years]
  • Participant-reported outcome for mobility [Срок оценки: through study completion, an average of 10 years]
  • Participant-reported outcome for fatigue [Срок оценки: through study completion, an average of 10 years]
  • Participant-reported outcome for social isolation (PROMIS) [Срок оценки: through study completion, an average of 10 years]
  • Participant-reported outcome for SARQoL. [Срок оценки: through study completion, an average of 10 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • University Hospital Toulouse — Toulouse

Публикации

  • Cabrol A, Shourick J, Coley N, Oustric S, Guyonnet S, Vellas B, Escourrou E, Andrieu S; IHU HealthAge INSPIRE/Open Science study group. Feeling Younger as an Indicator of Better Overall Intrinsic Capacities in the INSPIRE-T Cohort. Int J Geriatr Psychiatry. 2026 May;41(5):e70220. doi: 10.1002/gps.70220. PMID 42059106
  • Bellelli F, Raffin J, Cesari M, Guyonnet S, Furman D, Rolland Y, Vellas B, de Souto Barreto P; IHU HealthAge INSPIRE Platform Group; IHU HealthAge Open Science group. The association of pain with intrinsic capacity and the moderating role of inflammation in France: a cross-sectional analysis of the INSPIRE-T project. Lancet Healthy Longev. 2025 Dec;6(12):100798. doi: 10.1016/j.lanhl.2025.100798. E PMID 41360071

Идентификаторы

NCT: NCT04224038 · RC31/19/0236

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗