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

NCT07663955 | Not Yet Recruiting DMC

• 2 other identifiers: PR135/25EU Program Interreg Sudoe
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

adapted physical activity; frailty; sarcopenia; hospital discharge; acute exacerbation chronic pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Change in FRAILTY level from hospital discharge to 4 months (Visit 0) of post-discharge follow-up (Visit 1)

  Improvement in frailty is defined as an increase of 1 point or more on the Short Physical Performance Battery (SPPB) or Guralnik test between the SPPB score at 4-months of post-discharge follow-up (ensuring the complete fullfillment of the SHAPE program in interventional group) and the baseline SPPB score (at the time of hospital discharge)

  from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)

Secondary Outcomes (6)

• Change in SARCOPENIA degree from hospital discharge to 4 months of post-discharge follow-up

  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

  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

  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

  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

  from hospital discharge day until 4-months post-discharge follow-up

Other Outcomes (3)

• Change in the mortality rate from hospital discharge to 4 and 6 months of post-discharge follow-up

  at 4-months (in the interventional group once the SHAPE program is finished) and at 7 months after hospital discharge (in the interventional group more than 3-months after the end of the SHAPE program).

• Change in the readmission rate from hospital discharge to 4 and 6 months of post-discharge follow-up

  at 4-months (in the interventional group once the SHAPE program is finished) and at 7 months after hospital discharge (in the interventional group more than 3-months after the end of the SHAPE program)

• Change in the emergency room visit number from hospital discharge to 4 and 6 months of post-discharge follow-up

  at 4-months (in the interventional group once the SHAPE program is finished) and at 7 months after hospital discharge (in the interventional group more than 3-months after the end of the SHAPE program).

Study Arms (2)

Control group

NO INTERVENTION

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.

Interventional group

EXPERIMENTAL

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)

Other: Hospital System for Physical Activity and Active Participation

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)

Also known as: adapted physical activity, SHAPE programm

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Respiratory Department. Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Frailty; Sarcopenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mercè M GASA, Mercè, Respiratory Physician

CONTACT

034+932607685; mgasa@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mercè Gasa Galmes

Model Details: prospective longitudinal controlled, randomized trial

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 30, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)