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FrailtySHAPENCT07663955

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

A study testing Hospital System for Physical Activity and Active Participation in people with Frailty and Sarcopenia, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Frailty, Sarcopenia, Hospital Discharge
What is being tested?
Hospital System for Physical Activity and Active Participation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSpain
Study dates
1 Sep 2026to 30 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mercè M GASA, Mercè, Respiratory Physician contact

034+932607685 ext. 2758

mgasa@bellvitgehospital.cat

Spain1 site
  • Respiratory Department. Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Mercè M Gasa, Respiratory Physician, 034+932607685 ext. 2758, mgasa@bellvitgehospital.cat

    Marc M Paredes, Respiratory Physician, 034+932607685 ext. 2042, mparedesi@bellvitgehospital.cat

Other trials in Spain

About this study

Official title: 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.

Being tested
Hospital System for Physical Activity and Active Participation
Keywords
adapted physical activity, frailty, sarcopenia, hospital discharge, acute exacerbation chronic pulmonary disease
Medical subject headings
Frailty, Sarcopenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hospital System for Physical Activity and Active ParticipationOther

    Also called adapted physical activity, SHAPE programm

    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 groups in NCT07663955
Study groupRoleWhat they receive
Control groupNo interventionPatients 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 groupExperimentalPatients 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)
Receives: Other: Hospital System for Physical Activity and Active Participation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (6)
  1. Change in SARCOPENIA degree from hospital discharge to 4 months of post-discharge follow-up

    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)

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

  2. Change in DISPNEA and EXERCISE TOLERANCE from hospital discharge to 4 months of post-discharge follow-up

    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

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

  3. Change in the QUALITY OF LIFE level from hospital discharge to 4 months of post-discharge follow-up

    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).

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

  4. Change in MOOD STATUS from hospital discharge to 4 months of post-discharge follow-up

    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)

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

  5. Change in MUSCLE STRENGHT from hospital discharge to 4 months of 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

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

  6. Change in MUSCLE QUANTITY from hospital discharge to 4 months of 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion30 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective longitudinal controlled, randomized trial
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663955
Sponsor's protocol ID
PR135/25
Other IDs
EU Program Interreg Sudoe
Acronym
SHAPE
Status last verified
Jun 2026
First submitted
11 Jun 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Hospital System for Physical Activity and Active Participation in people with Frailty and Sarcopenia, run by Hospital Universitari de Bellvitge at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mercè M GASA, Mercè, Respiratory Physician (034+932607685 ext. 2758, mgasa@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

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SHAPE Clinical Trial NCT07663955 | AzTrials