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临床试验/NCT07663955
NCT07663955尚未招募不适用

The SHAPE Project (Hospital System for Physical Activity and Active Participation) After Hospitalized Decompensation of Respiratory Chronic Disease in Respiratory Patients

Hospital Universitari de Bellvitge1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1

研究概览

简要总结

It is widely established that a lack of adapted physical activity (APA) and sedentary behaviors increase the prevalence of frailty, which exacerbates chronic diseases. Hospital stays amplify this phenomenon, leading to physical deconditioning, often irreparable, especially in older patients if it is not detected and treated promptly. To date, there is no standard of care focused on APA to address frailty acquired during hospital stays. In this context, the SHAPE project (Hospital System for Physical Activity and Active Participation) aims to prevent dependency in older adults with chronic diseases by developing an innovative patient journey based on APA. The project seeks to reduce frailty acquired during hospital stays by establishing standards for APA prescription, based on early diagnosis and intervention. SHAPE ensures equal access to care through an accessible and user-friendly web platform, designed for older users and also including those in rural areas. It fosters the resilience of healthcare systems by integrating a preventive and multidisciplinary approach into hospital treatments and optimizes resources through a tiered care model that provides progressive and personalized care.

Although hospital stays have been shown to trigger physical deconditioning, there is no adapted physical activity program initiated by the hospital and followed at home after hospital discharge from a severe exacerbation in patients with chronic respiratory diseases. The SHAPE Project offers a highly beneficial tool for patients with acute or exacerbated chronic respiratory disease requiring hospitalization, promoting better overall recovery after discharge. Furthermore, this project will foster healthy lifestyles and promote health from a sustainability and prevention perspective. Of particular interest is the opportunity to offer a lifestyle change program (physical activity and hygiene-dietary measures) focused on respiratory patients and adapted to their specific needs. Moreover, the project is considered innovative in implementing healthy clinical practices through telemedicine. In addition, it offers post-hospital discharge services that, to date, have not been considered in a generic way for respiratory patients except in selective subgroups (post-COVID, patients included in lung transplant program, etc.).

In respiratory patients who have required high-risk admission due to decompensation, the implementation of the SHAPE program after hospital discharge as a support program that combines an adapted physical activity plan and general hygiene and dietary advice will improve the health indicators (frailty, sarcopenia, dyspnea, exercise tolerance, quality of life) of these patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Age 65 years or older
  • Admission at risk of functional decline (hospital admission lasting > 5 days) Discharge destination: Home or residence where the patient lived prior to admission
  • Favorable multidisciplinary assessment by the healthcare team responsible for the patient during admission regarding the patient's physical fitness to perform the SHAPE program

排除标准

  • Explicit decision by the patient not to participate
  • Musculoskeletal problem that limits mobility
  • Limiting sociopathy (socio-family environment not optimal to guarantee program adherence)
  • Drug dependence (condition at discharge not optimal to guarantee program adherence)
  • Insufficient digital literacy and/or lack of online resources that do not guarantee participation in telematic sessions
  • Discharge destination: Long-term convalescent care center
  • Advanced and/or terminal stage of lung disease (patients with the following resources activated: Home Care and Support Teams Program for advanced disease (PADES), intensive home care at discharge due to extreme frailty (AT-DOM), advanced chronic disease requiring palliative care and a life expectancy of 12 months or less (MACA))Unstable underlying non-pulmonary disease (whether medical or mental, for example: acute myocardial infarction) Recent myocardial infarction (MI), recent stroke, recent hospitalization for psychiatric decompensation*) *Recent = within the last 3 months
  • Unstable underlying pulmonary disease (vital hemoptysis, new thoracic neoplasm, high-intermediate risk pulmonary thromboembolism)

研究者

发起方
Hospital Universitari de Bellvitge
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mercè Gasa Galmes

Mercè Gasa Galmes

Hospital Universitari de Bellvitge

研究点 (1)

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