Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Device: ActivPAL3 VT (PAL Technologies Ltd).

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Boris Feldman; Phone Number: 604-575-5115; Email: boris.feldman@vch.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population will be recruited consecutively from the Acute Care of the Elderly Unit at SPH.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Frail hospitalized old adults; Over than 65-years of age Admitted into Acute Unit Nonambulatory	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.; Other Names: ActivPal sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total standing time	Total upright time will show a strong association with both continuous measures of frailty (Clinical Frailty Scale) and the presence of sarcopenia, as measured by ultrasound and bioelectric impedance measures.	2 weeks or shorter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily step counts	2. Daily step counts will show strong correlations with patient outcomes (length of stay, readmission rates, discharge to care facility, functional outcomes at 1year, and mortality rates).	2 weeks or shorter

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Kenneth Madden, MD, UBC

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: H19-04017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No