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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
90
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mercè M GASA, Mercè, Respiratory Physician
- 電話番号：2758 034+932607685
- メール：mgasa@bellvitgehospital.cat
研究場所
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、スペイン、08907
- Respiratory Department. Hospital Universitari de Bellvitge
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コンタクト：
- Mercè M Gasa, Respiratory Physician
- 電話番号：2758 034+932607685
- メール：mgasa@bellvitgehospital.cat
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コンタクト：
- Marc M Paredes, Respiratory Physician
- 電話番号：2042 034+932607685
- メール：mparedesi@bellvitgehospital.cat
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：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.
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実験的：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)
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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:
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in FRAILTY level from hospital discharge to 4 months (Visit 0) of post-discharge follow-up (Visit 1)
時間枠：from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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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)
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from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in SARCOPENIA degree from hospital discharge to 4 months of post-discharge follow-up
時間枠：from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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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)
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from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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Change in DISPNEA and EXERCISE TOLERANCE from hospital discharge to 4 months of post-discharge follow-up
時間枠：from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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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
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from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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Change in the QUALITY OF LIFE level from hospital discharge to 4 months of post-discharge follow-up
時間枠：from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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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).
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from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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Change in MOOD STATUS from hospital discharge to 4 months of post-discharge follow-up
時間枠：from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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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)
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from hospital discharge day (V0) until 4-months post-discharge follow-up (V1)
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Change in MUSCLE STRENGHT from hospital discharge to 4 months of post-discharge follow-up
時間枠：from hospital discharge day until 4-months post-discharge follow-up
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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
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from hospital discharge day until 4-months post-discharge follow-up
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Change in MUSCLE QUANTITY from hospital discharge to 4 months of post-discharge follow-up
時間枠：from hospital discharge day until 4-months post-discharge follow-up
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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
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from hospital discharge day until 4-months post-discharge follow-up
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in the mortality rate from hospital discharge to 4 and 6 months of post-discharge follow-up
時間枠：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).
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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
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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).
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Change in the readmission rate from hospital discharge to 4 and 6 months of post-discharge follow-up
時間枠：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)
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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
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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)
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Change in the emergency room visit number from hospital discharge to 4 and 6 months of post-discharge follow-up
時間枠：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).
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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
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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).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2028年3月30日
試験登録日
最初に提出
2026年6月11日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PR135/25
- EU Program Interreg Sudoe (その他の助成金/資金番号：European Union Programa Interreg Sudoe S2/4.5/F0311)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
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いいえ
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