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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06810661
Enrollment
60
Registered
2025-02-05
Start date
2025-01-06
Completion date
2026-08-30
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Frailty

Keywords

Frailty management, mobilization, sex differences, physical activity, cardiovascular disease

Brief summary

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.

Interventions

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.

Sponsors

Université de Sherbrooke
Lead SponsorOTHER
Vitalite Health Network
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
FrailtyAt enrollment and at the end of treatment, approximately 2 weeksFrailty 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.
Physical Activity & PosturesFrom enrollment through to the end of treatment, approximately 2 weeksMovement 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.

Secondary

MeasureTime frame
Hospital Length of StayFrom date of admission to the hospital until the date they will be discharged hospital (at least 3-days)
Hospital ReadmissionsHospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.

Countries

Canada

Contacts

CONTACTMyles W O'Brien, PhD
Myles.OBrien@USherbrooke.ca(506) 863-2250
CONTACTShirko Ahmadi, PhD
Shirko.Ahmadi@USherbrooke.ca506) 863-2250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026