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NCT Number: NCT06071793

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Critical Illness Confusion Delirium Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brant Community Healthcare System, Brantford, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Exclusion criteria for families include any major barriers to participation, i.e., physical, cognitive, emotional or capacity to understand and communicate with the team.

Treatment and study plan

Family involvement

Other

Family delivery of mobility activities

Primary outcomes

  1. Feasibility - consent rate

    Time frame: Study duration - up to one year

    We define a successful consent rate as > 70% of SDMs or patients approached to consent, agreeing to take part in the study

  2. Feasibility - recruitment rate

    Time frame: Study duration - up to one year

    We define a successful recruitment rate as achieving enrolment of four patients per month over the duration of the trial

  3. Feasibility - protocol adherence

    Time frame: During ICU stay, censored at 1 month

    We 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

  4. Feasibility - resources

    Time frame: Study duration - up to one year

    Physiotherapist 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.

Secondary outcomes

  1. Patient Delirium

    Time frame: During ICU stay, censored at 1 month

    CAM-ICU

  2. Patient & Family PTSD symptoms

    Time frame: 1 & 3 months

    IES-R

  3. Adverse Events

    Time frame: During ICU stay, censored at 1 month

    Falls, hypotension, bradycardia, line removal, unplanned extubation, inappropriate family intervention, unexpected injuries

  4. Family satisfaction

    Time frame: 1 & 3 months

    23-item Family Satisfaction in the ICU questionnaire; HADS scale

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Acronym: FIT-ICU

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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