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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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)
Respiratory Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
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)
Time frame: from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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)
Time frame: 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
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
Time frame: 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
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).
Time frame: 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
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)
Time frame: 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
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
Time frame: 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
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
Time frame: from hospital discharge day until 4-months post-discharge follow-up
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