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NCT Number: NCT06810661

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Georges-L.-Dumont University Hospital CentreDr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, E1C 2Z3, Canada

Location status: Recruiting

Location contact

Myles W O'Brien, PhD

CONTACT

[email protected]

(506) 863-2250

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobility promotion

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. Hospital Readmissions

    Time frame: Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Myles W O'Brien, PhD

CONTACT

[email protected]

(506) 863-2250

Shirko Ahmadi, PhD

CONTACT

[email protected]

506) 863-2250

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Vitalite Health Network

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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