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

17 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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)
Altro: 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)
Altri nomi:
  • adapted physical activity
  • SHAPE programm

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in FRAILTY level from hospital discharge to 4 months (Visit 0) of post-discharge follow-up (Visit 1)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in SARCOPENIA degree from hospital discharge to 4 months of post-discharge follow-up
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the mortality rate from hospital discharge to 4 and 6 months of post-discharge follow-up
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital Universitari de Bellvitge

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

30 marzo 2028

Date di iscrizione allo studio

Primo inviato

11 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PR135/25
  • EU Program Interreg Sudoe (Altro numero di sovvenzione/finanziamento: European Union Programa Interreg Sudoe S2/4.5/F0311)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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