Status:
NOT_YET_RECRUITING
Effect of a Combined Exercise and Anti-Inflammatory Nutritional Intervention in Frail Older Adults
Lead Sponsor:
Fundacion Miguel Servet
Collaborating Sponsors:
Adventia Pharma
Conditions:
Frail Elderly Syndrome
Malnutrition Elderly
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate whether a combined intervention of therapeutic exercise and anti-inflammatory nutritional supplementation improves physical performance and reduces syste...
Detailed Description
Frailty and malnutrition are prevalent, closely interconnected syndromes in older adults, associated with adverse outcomes such as functional decline, falls, institutionalization, prolonged hospitaliz...
Eligibility Criteria
Inclusion
- Patient aged ≥ 75 years.
- Diagnosis of frailty according to Linda Fried's criteria.
- Diagnosis of malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria.
- Barthel Index score ≥ 60 points.
- Absence of advanced chronic kidney disease (defined as glomerular filtration rate \< 25 mL/min/1.73m²).
- Absence of terminal illness as defined by SECPAL (Spanish Society for Palliative Care) criteria.
Exclusion
- Presence of type 1 or type 2 diabetes mellitus with poor metabolic control (HbA1c \> 8% or insulin-dependent).
- Oropharyngeal dysphagia to liquids that prevents safe intake of oral supplementation.
- Moderate-to-severe cognitive impairment, defined as a score ≥ 5 on the Global Deterioration Scale (GDS) of Reisberg.
- Refusal to sign the informed consent by the patient, primary caregiver, or legal representative, or inability to obtain it.
- Known allergy or intolerance to any component of the study supplements.
- Institutionalized in a long-term care or residential facility.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT07182292
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 19 2025
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