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Multicomponent Exercise to Prevent Hospitalization-Associated Disability

Study acronym: FIS_Prevention
StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study is a randomized controlled trial conducted in the Geriatrics Department of a tertiary hospital in Spain (Hospital Universitario de Navarra). Participants aged 75 years or older will be recruited within the first 48 hours of admission to the acute care ward. Eligible hospitalized patients will be randomly assigned to either the intervention or control group using permuted block randomization (block sizes of 8 and 10), with consideration of gender balance. Data will be collected at four time points: baseline assessment, hospital discharge, 1 month, and 3 months post-discharge. Inclusion criteria include age ≥75 years and admission to the acute care unit. Exclusion criteria include refusal or inability to provide informed consent, life expectancy \<3 months or terminal illness (oncological or non-oncological), inability to complete follow-up, medical contraindications to exercise, severe neurocognitive impairment (GDS-FAST stage 7), or severe disability (Barthel Index \<35).
Trial Details
NCT Number NCT07707310
Lead Sponsor Fundacion Miguel Servet
Conditions Clinical Deterioration
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov