Clinical trial NCT06810661: Managing Frailty Through Mobilization in Males and Female Inpatients with Cardiovascular Disease
Official title: Managing Frailty Through Mobilization in Males and Female Inpatients with Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Frailty
Keywords: Frailty management
mobilization
sex differences
physical activity
cardiovascular disease
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Vitalite Health Network
First posted: 2025-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frailty
timeFrame: At enrollment and at the end of treatment, approximately 2 weeks
measure: Physical Activity & Postures
timeFrame: From enrollment through to the end of treatment, approximately 2 weeks
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: From date of admission to the hospital until the date they will be discharged hospital (at least 3-days)
measure: Hospital Readmissions
timeFrame: Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.
Other outcomes:
Locations:
city: Moncton
country: Canada
facility: Dr. Georges-L.-Dumont University Hospital CentreDr. Georges-L.-Dumont University Hospital Centre
state: New Brunswick
Study officials:
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