NCT04366388

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2022Dec 2026

First Submitted

Initial submission to the registry

April 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.5 years

First QC Date

April 15, 2020

Last Update Submit

April 27, 2026

Conditions

Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Daily step counts

    2 weeks or shorter

Study Arms (1)

Frail hospitalized old adults

Over than 65-years of age Admitted into Acute Unit Nonambulatory

Device: ActivPAL3 VT (PAL Technologies Ltd).

Interventions

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.

Also known as: ActivPal sensor
Frail hospitalized old adults

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

RECRUITING

Study Officials

  • Kenneth Madden, MD

    UBC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Feldman

CONTACT

604-575-5115boris.feldman@vch.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 28, 2020

Study Start

June 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)