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

17 de junio de 2026 actualizado por: Mercè Gasa Galmes, Hospital Universitari de Bellvitge

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Mercè M GASA, Mercè, Respiratory Physician
  • Número de teléfono: 2758 034+932607685
  • Correo electrónico: mgasa@bellvitgehospital.cat

Ubicaciones de estudio

  • España
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, España, 08907
        • Respiratory Department. Hospital Universitari de Bellvitge
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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)
Otro: 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 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)
Otros nombres:
  • adapted physical activity
  • SHAPE programm

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in FRAILTY level from hospital discharge to 4 months (Visit 0) of post-discharge follow-up (Visit 1)
Periodo de tiempo: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in SARCOPENIA degree from hospital discharge to 4 months of post-discharge follow-up
Periodo de tiempo: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
Risk of Sarcopenia will be assessed by change in scoring at the SARC-F Questionnaire from hospital discharge to 4 month follow-up. The SARC-F Questionnaire is a simple five-question questionnaire about strength, walking ability, chair rise, stair climbing, and falls. The total score ranges from 0 to 10 points. A score <4 is considered at low risk for sarcopenia and a score ≥ 4 indicates a risk of sarcopenia and predictive physical limitations. Based on the SARC-F score at V1 will be categorized as: improvement (in patients scoring ≥ 4 at V0, if score <4 at V1), no change (if score at V0 and V1 do not shif risk) and worsening (if patients scoring <4 at V0, score >= 4 at V1)
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
Periodo de tiempo: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
Assessment by the 6-minute walk test (6MWT) at visit 0 (hospital discharge) and at visit 1 (4 months after hospital discharge). The 6MWT is a submaximal cardiorespiratory exercise test that consists of measuring the maximum distance a person can walk on a flat surface in 6 minutes. A clinical improvement is considered by an median increase of 30 meters
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
Periodo de tiempo: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
Assessment through the General Quality of Life Questionnaire (EuroQol-5D) calculating the change in the EuroQol-5D scores between V0 and V1. Health is evaluated across five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomofort, and Anxiety/Depression. Answers range from 1 (no problems) to 5 (extreme/unable to). The 5-digit code is converted into a single summary number using Value Sets applying country-specific formulas. A score of 1.0 represents perfect health (11111), while 0.0 represents death. Some highly severe health states (like 55555) can result in a score below 0 indicating values as "worse than death." The average Spanish score sits around 0.74 to 0.90. The Minimal Clinically Important Difference (MCID) is the smallest change a patient perceives as beneficial and it will be determined by a positive range between 0.04 and 0.15 from V0 to V1. The percentatges of patients achieving a positive MCID will be compared between groups (intervention vs control).
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
Periodo de tiempo: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
Assessment of Symptoms of Depression and/or Anxiety by the Goldberg Anxiety and Depression Scale (GADS). GADS is an 18-item clinical screening tool where the patient responds with either Yes or No based on how they have been feeling over the past month. It is structured by two subescales: anxiety (questions 1-9) and depression (qüestions 10-18) considering anxiety if >= 4 affirmative responses for the anxiety subscale and >= 2 affirmative responses for the depression subscale. The clínical response will be categorized as remission (if the Post-treatment score is below the diagnostic threshold (Anxiety ≤ 4 / Depression ≤ 2), as Response (Partial) if Score dropped by ≥ 2 points, but remains at or above the threshold, No Change if Score changed by only 1 point or remained exactly the same and Worsening if Score increased by ≥ 2 points. The percentatges of patients achieving remission, partial response, no change or worsened will be compared between groups (interventional vs control)
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
Periodo de tiempo: from hospital discharge day until 4-months post-discharge follow-up
Muscle strenght will be assessed by the Handgrip Strength (dynamometer). Normal handgrip strength values vary according to age, sex, and dominant hand, generally being higher in men than in women. A clinical indicator of frailty is a strength < 27 kg in men and < 16 kg in women. The participant exerts maximum grip strength for 3 seconds, with a 1-minute rest between each repetition, performing three attempts. The maximum value of the three attempts will be recorded for each hand, and the dominant hand will be specified. In older adults, the Standard MCID will be an improvement of 2.0 to 3.5 Kg from V0 to V1. The percentatges of patients achieving this MCID will be compared between the interventional group and the control group
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
Periodo de tiempo: from hospital discharge day until 4-months post-discharge follow-up
Muscle quantity tracking focuses on absolute dimensional loss or gain and it will be assessed by calculating the Muscle Thickness (MT) according to the length from the femur to the upper limit of the rectus femoris. A cutoff point was established for the diagnosis of low muscle mass in the rectus femoris in elderly subjects: 20 mm in men and 16 mm in women. A clinical positive shift will be defined as a change of ≥ 2 mm from V0 to V1. The percentatges of patients achieving this MCID will be compared between the interventional group and the control group
from hospital discharge day until 4-months post-discharge follow-up

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in the mortality rate from hospital discharge to 4 and 6 months of post-discharge follow-up
Periodo de tiempo: 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).
Check the survival rate of each patient in the healthcare network available at visit 1 (more than 3 months of hospital discharge) and visit 2 (after 6 months or more from hospital discharge). Then, the percentatges of survival patients will be compared between the interventional group and the control group
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
Periodo de tiempo: 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)
Check the readmission rate in each patient in the healthcare network available at visit 1 (more than 3 months of hospital discharge) and visit 2 (after 6 months or more from hospital discharge). Then, the percentatges of readmission patient's rate will be compared between the interventional group and the control group
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
Periodo de tiempo: 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).
Check the need of emergency department visits in each patient in the healthcare network available at visit 1 (more than 3 months of hospital discharge) and visit 2 (after 6 months or more from hospital discharge). The number of ED visits will be categorized as 0 (no visits), 1 if 1 visit at ED is needed, as 2 if 2 visits at ED are needed and as 3 if more than 2 visits at ED are needed. Then, the percentatges of the categorized variable will be compared between the interventional group and the control group
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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hospital Universitari de Bellvitge

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

30 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

23 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PR135/25
  • EU Program Interreg Sudoe (Otro número de subvención/financiamiento: European Union Programa Interreg Sudoe S2/4.5/F0311)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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