Frail Elderly SyndromeNCT04366388
Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly
An observational study of Frail Elderly Syndrome, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- ActivPAL3 VT (PAL Technologies Ltd).
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Study population will be recruited consecutively from the Acute Care of the Elderly Unit at SPH.
Who may be able to join
- be 65 years of age or older
- be admitted in ACE Unit
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
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
Boris Feldman, 604-875-5115, boris.feldman@vch.ca
Kenneth Madden, MD, 604-875-4931, kmmadden@mail.ubc.ca
About this study
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.
Read the 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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- ActivPAL3 VT (PAL Technologies Ltd).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivPAL3 VT (PAL Technologies Ltd).Device
Also called ActivPal sensor
. 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.
| Study group | Role | What they receive |
|---|---|---|
| Frail hospitalized old adults | Over than 65-years of age Admitted into Acute Unit Nonambulatory Receives: Device: ActivPAL3 VT (PAL Technologies Ltd). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks or shorter
Secondary outcomes (1)
Daily step counts
- 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).
Measured: 2 weeks or shorter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jun 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Madden, University of British Columbia
- Investigators
- Kenneth Madden, MD, Principal investigator, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366388
- Sponsor's protocol ID
- H19-04017
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a New Tool to Assess Frailty in Frail Hospitalized Elderly
- ClinicalTrials.gov ID
- NCT04366388
- Acronym / sponsor ID
- H19-04017
- Conditions
- Frail Elderly Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail hospitalized old adults | – | Device: ActivPAL3 VT (PAL Technologies Ltd).Over than 65-years of age Admitted into Acute Unit Nonambulatory |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Study population will be recruited consecutively from the Acute Care of the Elderly Unit at SPH.
Key inclusion criteria (2 listed)
- be 65 years of age or older
- be admitted in ACE Unit
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivPAL3 VT (PAL Technologies Ltd).Also: ActivPal sensor. 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. | Device | Frail hospitalized old adults |
Primary outcome
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.
1 secondary outcome
Daily step counts
Time frame: 2 weeks or shorter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth Madden, MD principal investigator
UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boris Feldman (604-575-5115, boris.feldman@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total standing time (time frame: 2 weeks or shorter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.