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Recruiting NCT04366388

Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly

Observational Frail Elderly Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ActivPAL3 VT (PAL Technologies Ltd)..
Who it may be relevant to
Registry conditions: Frail Elderly Syndrome. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The major purpose of this study is to establish the use of daily step counts as inexpensive, easy to measure marker for frailty and sarcopenia in an inpatient population of older adults.

Detailed description

The total time involved to complete study procedures will be between 2-3 hours at your enrollment and up to 10 minutes at your discharge. Investigators will invite participants to enrol in this study at your admission and discharge days.

Firstly, Investigators would like to collect some demographic data, including participants age and gender.

Then Investigators will ask participants to check their blood pressure and heart rate, weight, height and Body Mass Index.

Also Investigators will collect participant's medication List and Past Medical History.

Then, Investigators would like to ask participants to carry special device on their mid-thigh. It's called 'ActivPAL' and a trained research assistant will fit it on participant's dominant leg. This device has ability to detect the joint angle of participant's thigh to capture lying, sitting, standing, and stepping activities.

Then Investigators will proceed to ultrasound test. Participants will be asked to lay down on the bed with their legs supported by a pillow. Then a study physician will use ultrasound to measure participant's leg muscles. Three measurements will be taken for each participant.

After that participant will be asked to do a "Grip test". Participant will be asked to squeeze special device, called dynamometer, using your dominant hand. Each participant will be asked to make three attempts with half a minute break between each measurement.

Participant will be asked to walk 10-15 meters in order to measure their gait speed.

Impedance measures of body composition will be performed using an automatic scale.

At the end Investigators will ask you to measure participant's body structure, using skinfold/caliper device.

At participant discharge Investigators will remove 'ActivPal' sensor from their leg that was fitted at enrollment.

Interventions

  • Device ActivPAL3 VT (PAL Technologies Ltd).
    . The ActivPAL will be fitted by a trained research assistant on the mid-thigh of the participants' dominant leg. ActivPALs have an inclinometer that detects the joint angle of the thigh to capture lying, sitting, standing, and stepping activities.

Primary outcome measures

  • Total standing time [Time frame: 2 weeks or shorter]
Secondary outcome measures (1)
  • Daily step counts [Time frame: 2 weeks or shorter]

Eligibility criteria

Inclusion criteria

  • be 65 years of age or older
  • be admitted in ACE Unit

Exclusion criteria

  • be less than 65 years of age
  • be nonambulatory
  • be diagnosed with end-stage organ failure (end-stage COPD, renal failure requiring dialysis, end-stage heart failure)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, — Vancouver

Identifiers

NCT: NCT04366388 · H19-04017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗