Skip to content

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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06071793
Acronym
FIT-ICU
Enrollment
20
Registered
2023-10-06
Start date
2023-11-30
Completion date
2025-09-30
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Delirium

Brief summary

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.

Interventions

OTHERFamily involvement

Family delivery of mobility activities

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults (≥18 years) in the ICU * Anticipated length of stay ≥48 hours for whom a request for physiotherapy has been placed by the treating physician * Appropriateness for physiotherapy confirmed by the unit's physiotherapist. * Families will be eligible if they are able to be present in ICU during physiotherapist or research team work hours until they are cleared to deliver activities independently, then at least three times weekly thereafter.

Exclusion criteria

* Patients who are receiving end of life care * Patients who have high risk injuries including spinal cord injury or spinal fractures, post-operative from spinal surgery, and untreated hip or long bone fractures * Patients at risk of raised intracranial pressure (ICP) (e.g. Malignant middle cerebral artery stroke, large subarachnoid hemorrhage), admitted post trauma activation, post-operative from brain surgery or with external ventricular drain (EVD) in situ. * Patients who are bed-bound or require mechanical lift at baseline who would not otherwise be offered physiotherapy services. *

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - resourcesStudy duration - up to one yearPhysiotherapist and nurse outcomes will include inability to train families due to physiotherapy or team resources, and number of sessions per week cancelled due to inadequate staffing resources during the patients ICU stay.
Feasibility - consent rateStudy duration - up to one yearWe define a successful consent rate as \> 70% of SDMs or patients approached to consent, agreeing to take part in the study
Feasibility - recruitment rateStudy duration - up to one yearWe define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial
Feasibility - protocol adherenceDuring ICU stay, censored at 1 monthWe define successful adherence as average family involvement in ≥ 3 sessions/week. Furthermore, adherence to documentation of involvement will be successful if documented by family for ≥80% of sessions

Secondary

MeasureTime frameDescription
Patient DeliriumDuring ICU stay, censored at 1 monthCAM-ICU
Patient & Family PTSD symptoms1 & 3 monthsIES-R
Adverse EventsDuring ICU stay, censored at 1 monthFalls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries
Family satisfaction1 & 3 months23-item Family Satisfaction in the ICU questionnaire; HADS scale

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026