Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly

Frail Elderly Syndrome Clinical Trial

Official title:

Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04366388
• Other study ID #: H19-04017
• Status: Enrolling by invitation
• Start date: June 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty

Intervention

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.

Locations

Country	Name	City	State
Canada	Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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