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Идёт набор NCT06810661

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

Без фазы С лечением Cardiovascular Diseases Frailty

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mobility promotion.
Кому может быть актуально
Состояния в реестре: Cardiovascular Diseases, Frailty. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

  • Поведенческое 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 cardiovascula

Первичные конечные точки

  • Frailty [Срок оценки: At enrollment and at the end of treatment, approximately 2 weeks]
  • Physical Activity & Postures [Срок оценки: From enrollment through to the end of treatment, approximately 2 weeks]
Вторичные конечные точки (2)
  • Hospital Length of Stay [Срок оценки: From date of admission to the hospital until the date they will be discharged hospital (at least 3-days)]
  • Hospital Readmissions [Срок оценки: Hospital readmissions within 30 days will be quantified by medical records one-month after hospital discharge.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Канада · 1 центр
  • Dr. Georges-L.-Dumont University Hospital CentreDr. Georges-L.-Dumont University Hospital — Moncton

Публикации

  • O'Brien MW, Schwartz BD, Shivgulam ME, Daley WS, Frayne RJ, Kimmerly DS. Higher habitual lying time is inversely associated with vagal-related heart rate variability outcomes in younger adults. Appl Physiol Nutr Metab. 2023 Nov 1;48(11):876-881. doi: 10.1139/apnm-2023-0167. Epub 2023 Jul 10. PMID 37429038
  • O'Brien MW, Daley WS, Schwartz BD, Shivgulam ME, Wu Y, Kimmerly DS, Frayne RJ. Characterization of Detailed Sedentary Postures Using a Tri-Monitor ActivPAL Configuration in Free-Living Conditions. Sensors (Basel). 2023 Jan 4;23(2):587. doi: 10.3390/s23020587. PMID 36679384
  • Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7. PMID 33028215
  • O'Brien MW, Kimmerly DS, Theou O. Impact of age and sex on the relationship between carotid intima-media thickness and frailty level in the Canadian Longitudinal Study of Aging. J Cardiol. 2023 Aug;82(2):140-145. doi: 10.1016/j.jjcc.2023.01.004. Epub 2023 Jan 20. PMID 36682711
  • Kehler DS, Clara I, Hiebert B, Stammers AN, Hay JL, Schultz A, Arora RC, Tangri N, Duhamel TA. Sex-differences in relation to the association between patterns of physical activity and sedentary behavior with frailty. Arch Gerontol Geriatr. 2020 Mar-Apr;87:103972. doi: 10.1016/j.archger.2019.103972. Epub 2019 Nov 7. PMID 31739110
  • McCarthy C, Warne JP. Gender differences in physical activity status and knowledge of Irish University staff and students. Sport Sci Health. 2022;18:1283-91
  • Humphries KH, Izadnegahdar M, Sedlak T, Saw J, Johnston N, Schenck-Gustafsson K, Shah RU, Regitz-Zagrosek V, Grewal J, Vaccarino V, Wei J, Bairey Merz CN. Sex differences in cardiovascular disease - Impact on care and outcomes. Front Neuroendocrinol. 2017 Jul;46:46-70. doi: 10.1016/j.yfrne.2017.04.001. Epub 2017 Apr 18. No abstract available. PMID 28428055
  • Perez-Zepeda MU, Martinez-Velilla N, Kehler DS, Izquierdo M, Rockwood K, Theou O. The impact of an exercise intervention on frailty levels in hospitalised older adults: secondary analysis of a randomised controlled trial. Age Ageing. 2022 Feb 2;51(2):afac028. doi: 10.1093/ageing/afac028. PMID 35180287

Идентификаторы

NCT: NCT06810661 · 102088 (Event #: 59695)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗