Clinical Trial

Design and Validation of FEXO: A Playful Exercise Program for Institutionalized Frail Older Adults

Study acronym: FEXO-FRAIL
Completed
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Summary
This multicenter randomized controlled trial aims to evaluate the effectiveness of a playful multicomponent exercise intervention (FEXO - Fun Exercise for Older Adults) on intrinsic capacity, frailty, and functional health in institutionalized older adults aged over 75. The FEXO program combines aerobic, strength, balance, and flexibility training in a recreational format. Participants will be randomized to an experimental group (receiving the 14-week FEXO program) or a wait-list control group (continuing daily routines). After the first intervention phase, the control group will also complete the program. Primary outcomes include improvements in intrinsic capacity domains (cognition, locomotion, vitality, sensory, and psychological), frailty phenotype (Fried criteria), and physical function.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-20; most recent amendment 2026-04-20.
Status change: Not Yet Recruiting → Completed 2026-04-03
Trial Details
NCT Number NCT07133581
Lead Sponsor Cardenal Herrera University
Conditions Frailty Syndrome, Sarcopenia
Enrollment 80 participants
Start Date 2025-09-04
Primary Completion 2025-12-19 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-21