跳至主要内容
临床试验/NCT06810661
NCT06810661招募中不适用

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

Université de Sherbrooke1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Frailty

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Males

Experimental

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).

干预措施: Mobility promotion (Behavioral)

Females

Experimental

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).

干预措施: Mobility promotion (Behavioral)

结局指标

主要结局

Frailty

时间窗: 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.

Physical Activity & Postures

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Myles William O'Brien

Dr.

Université de Sherbrooke

研究点 (1)

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