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

Official title

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

Overview

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.

Interventions

• Other Hospital System for Physical Activity and Active Participation
  The SHAPE program is a standard post-hospitalization patient support program that combines physical activity and nutrition, maximizing patient participation and adherence evaluating their effectiveness on functional recovery. The SHAPE program, implemented by the specialized sports educators of the Siel Bleu Spain Foundation, will consist of the following action plan: * Initial individual assessment (baseline motivational and physical evaluation). * 24 Physical Activity and Fitness sessions su

Primary outcome measures

• Change in FRAILTY level from hospital discharge to 4 months (Visit 0) of post-discharge follow-up (Visit 1) [Time frame: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)]

Secondary outcome measures (6)

• Change in SARCOPENIA degree from hospital discharge to 4 months of post-discharge follow-up [Time frame: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)]
• Change in DISPNEA and EXERCISE TOLERANCE from hospital discharge to 4 months of post-discharge follow-up [Time frame: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)]
• Change in the QUALITY OF LIFE level from hospital discharge to 4 months of post-discharge follow-up [Time frame: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)]
• Change in MOOD STATUS from hospital discharge to 4 months of post-discharge follow-up [Time frame: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)]
• Change in MUSCLE STRENGHT from hospital discharge to 4 months of post-discharge follow-up [Time frame: from hospital discharge day until 4-months post-discharge follow-up]
• Change in MUSCLE QUANTITY from hospital discharge to 4 months of post-discharge follow-up [Time frame: from hospital discharge day until 4-months post-discharge follow-up]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Respiratory Department. Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat

Identifiers

NCT: NCT07663955 · PR135/25 · EU Program Interreg Sudoe

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗