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ICOPE INTENSE-K Pilot Study

ICOPE INTENSE-K Pilot Study

Recruiting
65-85 years
All
Phase N/A

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Overview

ICOPE could constitute the reference model of care for healthy aging. More specifically, our hypothesis is that the intervention implemented in ICOPE may directly or indirectly prevent immuno-senescence, the loss of mobility and the cognitive decline. In future Geroscience clinical trials, ICOPE-Intense could become a benchmark to reduce the rate of aging with a strong non-pharmacological intervention and state a reference intervention to compare with new gerotherapeutic drugs.

Description

In this pilot study, the concept of prevention proposed by the WHO, for everyday life is taken to the extreme to be able to judge what is the maximum effect size on key functions of aging (mobility, cognition, immunity) that can be expected and achieved by a nonpharmacological intervention. The results obtained will constitute reference data for the future, during the investigation on new gerotherapeutic drugs or other nonpharmacological interventions. Taking into account the hypothesis of a synergistic effect between Ketones and non-pharmacological intervention, the intense ICOPE program makes it possible to study the effect size of Ketones under optimal experimental conditions.

Eligibility

Inclusion Criteria:

  • Independent-living (ADL ≥5/6)
  • Men and women
  • Mobility impairment (5 Chair-rise test >12 seconds)
  • Sedentarism (spend six or more hours per day sitting or lying down)
  • Positive screening for cognitive impairment according to the ICOPE screening tool with MMSE [25-28]
  • BMI ≥25 kg/m2

Exclusion Criteria:

  • Unintentional weight loss (≥10%) in past 6 months
  • Dementia
  • Life-threatening illnesses, with a life expectancy (judged by the investigating doctor) of less than 1 year
  • Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina or any other contraindication to physical activity (as determined by a physician) or comorbid disease that would impair ability to participate in the ICOPE intense intervention such as renal failure on hemodialysis, severe psychiatric disorder (depressive participant will not be excluded)
  • Organizational inability (three-time per week during the 60 days)
  • Living in a Nursing-Home
  • Under legal protection measure (guardianship, curatorship, safeguard of justice

Study details
    Ageing

NCT07048860

University Hospital, Toulouse

27 July 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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