Managing Frailty Through Mobilization in Males and Female Inpatients With Cardiovascular Disease

April 28, 2026 updated by: Myles William O'Brien, Université de Sherbrooke
Frailty describes the overall health of a person. Inpatients with cardiovascular problems have a higher risk for frailty - or the sick are more likely to get sicker - causing longer hospital stays, hospital readmission, and death. Females are particularly vulnerable to these problems, generally displaying higher frailty levels than males. In hospital, patients spend almost all their time in bed, and this lack of movement worsens cardiovascular and musculoskeletal health, sometimes lengthening patients' hospital stay and priming them for another cardiovascular event. Prolonged sedentary time may be more detrimental on frailty among females than males. The proposed pilot project will test if an in-hospital General Medicine mobilization program reduces frailty (measure of overall health) in male and female inpatients with cardiovascular disease. A Kinesiologist will provide daily check-ins and promote daily movement (e.g., standing more, resistance bands, physical activity promotion, etc.). The investigators expect both males and females will lower their frailty levels, but given their higher frailty levels in general and because females are typically less active than males, the investigators expect the intervention's effects to be greatest among females. Sixty patients (30 females) will be recruited. Patients with a major heart problem, projected to be in-hospital for at least 3-days, and can independently provide consent. Frailty will be measured using a validated questionnaire. Participants will also be equipped with activity monitors for 24h/d continuous wear to measure amount of time spent stepping, sitting, and lying. Hospital records will be used for length of stay and readmissions. The investigators will compare the outcomes (activity and frailty) between males and females to determine if the intervention impacted each sex differently. This work will guide improved care plans to decrease frailty and improve health outcomes in both male and female patients with heart problems.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2Z3
        • Recruiting
        • Dr. Georges-L.-Dumont University Hospital CentreDr. Georges-L.-Dumont University Hospital Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are admitted to unit 4C at the Vitalité Health Network
  • Patients who have a cardiovascular disease (e.g., heart failure)
  • Those who are projected to be in-hospital for at least 3-days
  • Patients who are not in a shared room with another study participant
  • Patients who are able to independently provide consent or have a caregiver provide consent
  • Can communication in French or English

Exclusion Criteria:

-Patients enrolled in other clinical trials or interventions that might confound the results of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Males
A team of Kinesiologists visit the patients daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed).
Behavioral: Mobility promotion
At the Georges-L. Dumont hospital, a patient mobilization program has been introduced on floor 4C that embeds Kinesiologists within care to visit patients daily. A team of Kinesiologists visit the patients daily to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). The investigators propose to continue this individualized model but incorporate activity and frailty measures in males and females with cardiovascular disease.
Experimental: Females
A team of Kinesiologists visit the patients daily from admission to discharge to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed).
Behavioral: Mobility promotion
At the Georges-L. Dumont hospital, a patient mobilization program has been introduced on floor 4C that embeds Kinesiologists within care to visit patients daily. A team of Kinesiologists visit the patients daily to promote movement and help them mobilize to the best of their capabilities (e.g., walking, standing, or sitting on the edge of the bed). The investigators propose to continue this individualized model but incorporate activity and frailty measures in males and females with cardiovascular disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: At enrollment and at the end of treatment, approximately 2 weeks
Frailty will be assessed in each participant using the validated Frailty Index used extensively by our group, which calculates frailty as a proportion of health problems present in each person. A trained researcher will help the patient complete the Frailty Index and measure participants' frailty using the Clinical Frailty Scale (scored from 1 [very fit] to 9 [terminally ill]). This scale ensures us a way to obtain a graded frailty score for participants who might be unable to complete the longer questionnaire with assistance.
At enrollment and at the end of treatment, approximately 2 weeks
Physical Activity & Postures
Time Frame: From enrollment through to the end of treatment, approximately 2 weeks
Movement will be measured using activPAL inclinometers positioned on the patients' torso, thigh, and shin. Monitors will be waterproofed and attached 24-hr/day for at least 3-days using a clear medical dressing. We have safely attached these devices to patients' skin for longer durations (14+ days). Amount of time spent (minutes/day) spent on different activities including physical activity (e.g., steps, physical activity intensity), upright posture, and detailed sedentary postures (e.g., sitting versus lying time) will be determined via validated, custom software that was developed and openly published by the investigator's group.
From enrollment through to the end of treatment, approximately 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital Length of Stay
Time Frame: From date of admission to the hospital until the date they will be discharged hospital (at least 3-days)
From date of admission to the hospital until the date they will be discharged hospital (at least 3-days)
Hospital Readmissions
Time Frame: Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.
Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Vitalite Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102088 (Event #: 59695)

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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