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

Sponsor
Hospital Universitari de Bellvitge
Study ID
NCT07663955
Status
Not Yet Recruiting

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Conditions

  • Acute Exacerbation Chronic Pulmonary Disease
  • Frailty
  • Hospital Discharge
  • Physical Activity
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hospital System for Physical Activity and Active Participation — OTHER
    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 supervised by a specialized sports educator, distributed in two sessions per week, 12 consecutive weeks. The program is designed so that the supervision of the specialized sports coach will be gradually reduced as the intervention progresses until the patient is able to adopt an independent behavioral habit by a stepped-care. * Final individual (final progress asssessment to provide recommendations for the patient's future autonomy (without supervision)

Study Details

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.

Key Dates

First listed
Jun 23, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2026
Completion
Mar 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control group
    Patients randomized to the control group will be offered an educational brochure with general discharge recommendations focused on promoting the resumption of physical activity and improving nutritional habits.
  • Experimental: Interventional group
    Patients randomized to the interventional group will be offered an educational brochure with general discharge recommendations focused on promoting the resumption of physical activity and improving nutritional habits PLUS will be enrolled in the SHAPE program (Intervention)

Primary Outcome Measure

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) ]

Central Contacts

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