The SHAPE Project (Hospital System for Physical Activity and Active Participation) After Hospitalized Decompensation of Respiratory Chronic Diseases (SHAPE)
2026年6月17日 更新者：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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mercè M GASA, Mercè, Respiratory Physician
- 电话号码：2758 034+932607685
- 邮箱：mgasa@bellvitgehospital.cat
学习地点
-
-
Barcelona
-
L'Hospitalet de Llobregat、Barcelona、西班牙、08907
- Respiratory Department. Hospital Universitari de Bellvitge
-
接触：
- Mercè M Gasa, Respiratory Physician
- 电话号码：2758 034+932607685
- 邮箱：mgasa@bellvitgehospital.cat
-
接触：
- Marc M Paredes, Respiratory Physician
- 电话号码：2042 034+932607685
- 邮箱：mparedesi@bellvitgehospital.cat
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：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.
|
|
|
实验性的：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)
|
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:
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in FRAILTY level from hospital discharge to 4 months (Visit 0) of post-discharge follow-up (Visit 1)
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in SARCOPENIA degree from hospital discharge to 4 months of post-discharge follow-up
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the mortality rate from hospital discharge to 4 and 6 months of post-discharge follow-up
大体时间：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
大体时间：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
大体时间：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).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2028年3月30日
研究注册日期
首次提交
2026年6月11日
首先提交符合 QC 标准的
2026年6月17日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PR135/25
- EU Program Interreg Sudoe (其他赠款/资助编号：European Union Programa Interreg Sudoe S2/4.5/F0311)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.