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Next generation assessments of physical function in intensive care unit survivors - validity of two Fitbit tracking devices and smartphone apps

Next generation assessments of physical function in intensive care unit survivors -Validity of two FitBit activity tracking devices and smart phone apps

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000681459
Enrollment
60
Registered
2016-05-25
Start date
2016-05-30
Completion date
2017-12-30
Last updated
2024-08-26

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

Conditions

None listed

Brief summary

This project will compare two "next generation" methods of measurement of physical function to the accepted gold standard assessment of physical function: in-person testing using validated physical function outcome measures. We will measure physical activity using (1) wearable devices and smartphone applications and (2) a telephone assessment of global function; we will compare these convenient at home assessments to the gold standard in-person assessments in order to quantify the validity and feasibility of these new approaches to inform future clinical trial design. The results will be used both within Australia and New Zealand, and internationally, to design future RCTs aiming to measure post discharge and long term physical function outcomes. Moreover, our results will also inform the design of new in-home monitoring strategies for post-ICU clinics and interventions.

Interventions

In the outpatient department of the hospital, participants will be provided with a smartphone application (Health App - with the smartphone worn in a pocket) and two wearable devices (Fitbit One worn clipped to the waistband and Fitbit Flex worn on the wrist). They will complete the gold standard battery of physical function tests for approximately 30 minutes as well as conduct a 10 minute treadmill walk while wearing the devices, including the smartphone. The participants will be asked to wear

In the outpatient department of the hospital, participants will be provided with a smartphone application (Health App - with the smartphone worn in a pocket) and two wearable devices (Fitbit One worn clipped to the waistband and Fitbit Flex worn on the wrist). They will complete the gold standard battery of physical function tests for approximately 30 minutes as well as conduct a 10 minute treadmill walk while wearing the devices, including the smartphone. The participants will be asked to wear the devices and to carry the smartphone for a 7-day period for as much of the 24 hours as possible in their usual living accommodations. After Day 7, they will undergo a twenty minute telephone assessment of physical function, relay the data from the smartphone applications and be prompted to return the wearable devices via the pre-paid envelope.

Sponsors

Australia and New Zealand Intensive Care Research Centre (ANZIC-RC), Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training

Eligibility

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

Inclusion criteria

Participants who were previously admitted to the Intensive Care Unit (ICU) and mechanically ventilated for at least 48 hours and who: 1. report being able to walk continuously for at least 10 minutes prior to ICU admission 2. own a smartphone 3. live within 40km of the recruiting hospital 4. admitted to ICU in the previous 6 months

Exclusion criteria

1. The ICU-requiring injury prevents post-discharge ambulation (e.g. traumatic lower limb amputation) 2. Inadequate English spoken to enable completion of assessments 3. Pregnancy 4. Severe cognitive or neurological deficits likely to impact the ability to complete assessments

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026