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Family Integration in Therapy Activities in the Intensive Care Unit: The FIT-ICU Feasibility Study

Study acronym: FIT-ICU
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 24, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Jun 30, 2025 to Sep 30, 2025v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Mar 21, 2025 to Jun 30, 2025
    • Site details revised at 3 of 3 sites
    v6
  3. Study sites: 1 to 3v5
  4. Primary completion date: Apr 30, 2024 to Mar 21, 2025
    • Study completion date: Jul 1, 2024 to Mar 21, 2025
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Start date: Oct 1, 2023 to Nov 30, 2023v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An ICU admission is stressful for not only patients but their families as well. Research has shown that involving family members during a loved one's ICU stay can be helpful for them, but there is not clear direction on the best way to do this. For patients, family presence as well as early movement during their ICU stay has been shown to help recovery from things like delirium (a state of confusion) faster, and might prevent the weakness that can happen with a stay in the ICU. In this study, the investigators will explore whether having family help with moving patients through physiotherapy guided exercise can help both patients and families have a better experience and result from their ICU stay. The investigators hypothesize that family involvement in activities as part of an overall physiotherapy treatment plan will provide a tangible means for family members to engage in the care of their critically ill loved one, thus improving outcomes for both critically ill patients and family members.
Trial Details
NCT Number NCT06071793
Lead Sponsor St. Joseph's Healthcare Hamilton
Conditions
(from sponsor)		 Critical Illness, Delirium
Related terms Critical Illness, Delirium
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov