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NCT Number: NCT04366388

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.

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue

Vancouver, British Columbia, V5Z 1M9, Canada

Location status: Recruiting

Location contact

Boris Feldman

CONTACT

[email protected]

604-875-5115

Graydon Meneilly, MD, FRCPC

SUB_INVESTIGATOR

Kenneth M Madden, MD MSc FRCPC

PRINCIPAL_INVESTIGATOR

Kenneth Madden, MD

CONTACT

[email protected]

604-875-4931

Nicole Stewart, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

ActivPAL3 VT (PAL Technologies Ltd).

Device

. 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

Primary outcomes

  1. Total standing time

    Time frame: 2 weeks or shorter

    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.

Secondary outcomes

  1. Daily step counts

    Time frame: 2 weeks or shorter

    • 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Boris Feldman

CONTACT

[email protected]

604-575-5115

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2020
Registry last updated
May 1, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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