Wpływ aktywności fizycznej na jakość mięśni, skład ciała i odpowiedź funkcjonalną u osób po operacji bariatrycznej (BAR-EX)
Effect of a Concurrent Exercise Program on Muscle Quality, Body Composition, Functional Response, and Quality of Life in Individuals Undergoing Bariatric Surgery: Protocol for a Randomized Controlled Clinical Trial
This study aims to evaluate the effect of a 5-week concurrent exercise program (aerobic and resistance training) on muscle quality, body composition, functional response, and quality of life in individuals undergoing bariatric surgery.
This is a single-center, prospective, longitudinal, randomized controlled clinical trial with two parallel groups: an intervention group and a control group. A total of 87 adults aged 18 to 60 years who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass and have a medical indication for metabolic rehabilitation will be recruited.
The intervention group will participate in a structured, semi-supervised concurrent exercise program for 5 weeks, consisting of two in-person sessions per week (10 sessions in total), whereas the control group will continue receiving usual kinesiology care and standard clinical management according to the institutional rehabilitation protocol at Clínica BUPA Santiago. All participants will be assessed at two time points: baseline, during the fourth postoperative week, and at week 7.
The primary outcome will be the change in rectus femoris muscle quality assessed by ultrasound (echo intensity). Secondary outcomes will include body composition (bioelectrical impedance analysis), functional response (One-minute Sit-to-Stand Test), and quality of life (Moorehead-Ardelt II questionnaire).
Additionally, adherence to the exercise program in the intervention group will be assessed as the percentage of attendance at supervised exercise sessions, and its association with the magnitude of changes in study outcomes will be explored.
The findings are expected to provide clinically relevant evidence regarding the effectiveness of exercise during the early postoperative period and to contribute to the optimization of metabolic rehabilitation strategies following bariatric surgery.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Bariatric surgery is an effective treatment for severe obesity; however, the early postoperative period is frequently associated with loss of lean body mass, reduced muscle strength, and functional decline, which may negatively affect recovery and quality of life. Physical exercise has been proposed as a key component of metabolic rehabilitation, although evidence regarding structured concurrent exercise programs initiated early after bariatric surgery remains limited, particularly with respect to muscle quality.
The aim of this study is to evaluate the effect of a 5-week concurrent exercise program on rectus femoris muscle quality in individuals undergoing bariatric surgery, compared with a control group receiving usual kinesiology care. Secondary objectives include evaluating changes in body composition, functional response, and quality of life, as well as exploring the association between exercise adherence and the magnitude of observed changes.
This is a single-center, prospective, longitudinal, randomized controlled clinical trial with two parallel groups (intervention and control). A total of 87 adults aged 18-60 years who have undergone sleeve gastrectomy or Roux-en-Y gastric bypass at Clínica BUPA Santiago and have a medical indication for metabolic rehabilitation will be recruited. Participants will undergo baseline assessment during the fourth postoperative week and will then be randomly allocated in a 1:1 ratio to the intervention or control group using a sequence generated and administered by an individual independent of the assessors and treating physical therapists.
The intervention group will participate in a structured, semi-supervised 5-week concurrent exercise program designed according to the FITT principle (Frequency, Intensity, Time, and Type of exercise). The program will combine aerobic and resistance training and will include two supervised in-person sessions per week (10 sessions in total) plus one complementary home-based session each week. Aerobic training will progress from continuous moderate-intensity exercise to interval training, whereas resistance training will progressively increase training volume for large muscle groups. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion scale, and resistance loads will be individually adjusted according to each participant's clinical tolerance.
Participants allocated to the control group will continue receiving usual kinesiology care and standard clinical management according to the institutional metabolic rehabilitation protocol at Clínica BUPA Santiago. This program will also follow the FITT principle and will include two supervised sessions per week consisting of continuous aerobic exercise, targeted muscle strengthening, and static stretching, consistent with routine clinical practice, without the structured progression incorporated into the concurrent exercise program.
Following the 5-week intervention period, both groups will complete one week without supervised exercise sessions to minimize the acute effects of exercise on muscle measurements. Final assessments will be performed at week 7.
The primary outcome will be the change in rectus femoris muscle quality assessed by musculoskeletal ultrasound using echo intensity as the primary indicator. Secondary outcomes will include body composition assessed by bioelectrical impedance analysis, functional response assessed using the One-minute Sit-to-Stand Test, and quality of life assessed using the Moorehead-Ardelt II questionnaire.
Exercise adherence will be assessed exclusively in the intervention group as the percentage of attendance at supervised exercise sessions. The association between adherence and the magnitude of outcome changes will also be explored using a dose-response approach.
Statistical analyses will follow the intention-to-treat principle. The primary analysis will be performed using analysis of covariance (ANCOVA), with study group as the fixed factor and baseline values as covariates, adjusting for prespecified clinically relevant covariates when appropriate. Secondary outcomes will be analyzed using the same approach. Complementary analyses will include within- and between-group comparisons using parametric or non-parametric tests according to data distribution, estimation of effect sizes, and exploratory correlation and linear regression analyses to evaluate the association between exercise adherence and changes in study outcomes.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: María José Pabst Perez, MSc
- Numer telefonu: +56950023025
- E-mail: majose.pabst@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Tomás Vergara Soria, Kinesiólogo
- Numer telefonu: +56988289188
- E-mail: tomasvergarasoria21@gmail.com
Lokalizacje studiów
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7820830
- Rekrutacyjny
- Clínica BUPA, Santiago
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Kontakt:
- Tomás Vergara Soria, Kinesiólogo
- Numer telefonu: +56988289188
- E-mail: tomasvergarasoria21@gmail.com
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Kontakt:
- Sebastian Barrios, Kinesiólogo
- Numer telefonu: +56984513233
- E-mail: se.barriosv@gmail.com
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Główny śledczy:
- Tomás Vergara Soria, Kinesiólogo
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria
- Adults aged 18-60 years.
- Participants eligible for the institutional PAD (Pago Asociado a Diagnóstico) bariatric surgery program with medical indication for metabolic rehabilitation.
- Undergoing sleeve gastrectomy or Roux-en-Y gastric bypass at Clínica BUPA Santiago.
- Medical indication for metabolic rehabilitation.
- Able and willing to provide written informed consent.
Exclusion Criteria
- Type 1 diabetes mellitus or type 2 diabetes mellitus with severe complications (including stage G4-G5 nephropathy, severe autonomic neuropathy, or high risk of exercise-related hypoglycemia).
- Severe musculoskeletal disorders limiting participation in the exercise program.
- Acute cardiovascular event within the previous 3 months or medical contraindication to supervised exercise.
- Severe cardiorespiratory disease or dyspnea at rest or with minimal exertion.
- Dependence on supplemental oxygen.
- Bariatric surgery complications (e.g., leak, bleeding, stenosis, or intra-abdominal abscess).
- Liver failure, kidney failure, or any other clinical condition compromising safe participation in the exercise program.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Concurrent Physical Exercise Program
Participants allocated to the intervention group will complete a structured, semi-supervised concurrent exercise program during the postoperative period following bariatric surgery. Participants will enter the study during postoperative week 4 and undergo a baseline assessment before starting the intervention. The program will last 5 weeks and will include 10 supervised in-person sessions (2 sessions/week, approximately 60 minutes each) and one complementary home-based session per week. After completion of the intervention, participants will remain one week without supervised exercise sessions before the week 7 follow-up assessment. |
Concurrent physical exercise program of 5 weeks combining aerobic and resistance training in individuals undergoing bariatric surgery. The program includes two supervised in-person sessions per week (10 sessions total), each lasting approximately 60 minutes, and one recommended weekly home-based session guided by a prescribed exercise plan. Aerobic exercise is performed at moderate to high intensity, monitored using the Borg Rating of Perceived Exertion scale. Resistance training targets major muscle groups and is prescribed based on an estimated one-repetition maximum (1RM), with progression in volume and intensity according to individual tolerance and safety criteria. The program begins at postoperative week 4. After completing the 5-week intervention, participants undergo a 1-week period without supervised sessions before the post-intervention assessment.
Inne nazwy:
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Aktywny komparator: Usual Metabolic Rehabilitation Program
Participants allocated to the control group will receive the usual metabolic rehabilitation program at Clínica BUPA Santiago. The rehabilitation program will follow the FITT principle (Frequency, Intensity, Time, and Type of exercise) and will include two supervised sessions per week for 5 weeks consisting of continuous aerobic exercise, targeted muscle strengthening, and stretching according to the institutional protocol. All participants will undergo baseline and week 7 assessments. |
Usual institutional metabolic rehabilitation program at Clínica BUPA Santiago based on the FITT principle (Frequency, Intensity, Time, and Type of exercise). The program includes supervised continuous aerobic exercise, targeted muscle strengthening, and stretching delivered twice weekly for 5 weeks according to the institutional clinical protocol. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in rectus femoris muscle quality (echo intensity; grayscale units 0-255)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Muscle quality will be assessed by ultrasound as echo intensity (mean grayscale value, 0-255) within a standardized region of interest, analyzed using ImageJ, at baseline and post-intervention. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in percent body fat (%)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Percent body fat (%) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Change in fat mass (kg)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Fat mass (kg) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Change in skeletal muscle mass (kg)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Skeletal muscle mass (kg) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Change in 1-minute Sit-to-Stand performance (1min-STST)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Functional response will be assessed using the One-minute Sit-to-Stand Test (1min-STST). The primary metric is the total number of completed repetitions in 60 seconds performed using a standard chair. Perceived exertion (modified Borg scale) may be recorded as a complementary measure. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Adherence to the exercise program (supervised in-clinic sessions)
Ramy czasowe: During the 5-week intervention period (calculated at the end of the program based on attendance to the 10 supervised sessions).
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Attendance rate to supervised in-clinic sessions at Clínica BUPA during the intervention. Adherence will be calculated as: adherence (%) = (number of attended sessions / 10) × 100. For descriptive purposes, adherence will be categorized as high (8-10 sessions; ≥80%), moderate (6-7 sessions; 60-79%), and low (0-5 sessions; <60%). Adherence ≥80% will be considered clinically acceptable. |
During the 5-week intervention period (calculated at the end of the program based on attendance to the 10 supervised sessions).
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Change in visceral fat area (cm²)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Visceral fat area (cm²) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Change in basal metabolic rate (kcal/day)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Body composition will be assessed using bioelectrical impedance analysis (InBody S10) under standardized conditions before and after the intervention. Basal metabolic rate (kcal/day) will be recorded at baseline and post-intervention. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Change in rectus femoris muscle thickness (cm)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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ectus femoris muscle thickness (cm) will be assessed by ultrasound under standardized conditions at baseline and post-intervention. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Change in rectus femoris cross-sectional area (cm²)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Rectus femoris cross-sectional area (cm²) will be assessed by ultrasound under standardized conditions at baseline and post-intervention. Change will be calculated as Δ = post - pre |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Change in intramuscular fat infiltration assessed by ultrasound echo intensity (grayscale units 0-255)
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of intervention and 1 week of rest).
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Intramuscular fat infiltration will be assessed by musculoskeletal ultrasound using rectus femoris echo intensity (grayscale units 0-255) under standardized acquisition conditions. Images will be analyzed using ImageJ. Change will be calculated as Δ = post - pre. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of intervention and 1 week of rest).
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Change in quality of life assessed by the Moorehead-Ardelt II questionnaire
Ramy czasowe: Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Quality of life will be assessed using the Moorehead-Ardelt II questionnaire, a bariatric surgery-specific instrument that evaluates domains including self-esteem, physical well-being, social relationships, work, and sexuality. Total score (and domain scores, if applicable) will be compared before and after the intervention. |
Baseline (pre-intervention) and 7 weeks after baseline (after 5 weeks of exercise and 1 week of rest).
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Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: María José Pabst Pérez, MSc, Universidad Autónoma de Chile
- Krzesło do nauki: Luis Astete, MSc, Universidad Autónoma de Chile
- Krzesło do nauki: Nicolas Arancibia Ramirez, Kinesiólogo, Clinica Alemana
- Dyrektor Studium: Rosario Alonso Domínguez, PhD., Universidad de Salamanca. España
- Dyrektor Studium: María de la Luz Tocino, PhD., University of Salamanca
- Dyrektor Studium: Matias Otto Yañez, PhD., Universidad Autónoma de Chile. Chile
- Krzesło do nauki: Paloma Lillo, MsC, Universidad Silva Henriquez
- Krzesło do nauki: Carla Martinez Dominguez, Kinesióloga, Clinica Bupa Santiago
- Główny śledczy: Tomás Vergara Soria, Kinesiólogo, Clínica BUPA Santiago
- Krzesło do nauki: Sebastian Barrios Valenzuela, Kinesiólogo, Clínica BUPA Santiago
- Krzesło do nauki: Erika Troncoso, MsC, Clinica las Condes
- Krzesło do nauki: Karen Castañeda Lavin, MsC, University of Americas - Chili
Publikacje i pomocne linki
Publikacje ogólne
- Tamboli RA, Hossain HA, Marks PA, Eckhauser AW, Rathmacher JA, Phillips SE, Buchowski MS, Chen KY, Abumrad NN. Body composition and energy metabolism following Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2010 Sep;18(9):1718-24. doi: 10.1038/oby.2010.89. Epub 2010 Apr 22.
- Otto-Yanez M, Torres-Castro R, Barros-Poblete M, Barros M, Valencia C, Campos A, Jadue L, Puppo H, Seron P, Vilaro J. One-minute sit-to-stand test: Reference values for the Chilean population. PLoS One. 2025 Jan 29;20(1):e0317594. doi: 10.1371/journal.pone.0317594. eCollection 2025.
- Complicaciones a largo plazo y efectos secundarios de la cirugía bariátrica: una revisión sistemática. Journal of Negative and No Positive Results, 6(6), 582-589. https://doi.org/10.19230/jonnpr.1584
- Gonzalez-Molero I, Garcia Arnes JA, Dominguez Lopez M, Gallego JL. [Persistent hypoglycemia in a patient with bariatric surgery]. Med Clin (Barc). 2011 Oct 22;137(11):522-3. doi: 10.1016/j.medcli.2011.01.001. Epub 2011 Mar 10. No abstract available. Spanish.
- National Institute of Diabetes and Digestive and Kidney Diseases. (2020). Efectos secundarios de la cirugía para adelgazar (bariátrica). Recuperado de https://www.niddk.nih.gov/health-information/informacion-de-la-salud/control-de-peso/cirugia-adelgazar-bariatrica/efectos-secundarios
- Muñoz, R., Hernández, J., Palacio, A., Maiz, C., & Pérez, G. (2016). El ejercicio físico disminuye la pérdida de masa magra en pacientes obesos sometidos a cirugía bariátrica. Revista Chilena de Cirugía, 68(6), 303-308. https://doi.org/10.1016/j.rchic.2016.05.007
- Alvero-Cruza, J. R., Correas Gómez, L., Ronconi, M., Fernández Vázquez, R., & Porta i Manzanido, J. (2011). La bioimpedancia eléctrica como método de estimación de la composición corporal, normas prácticas de utilización[Bioelectrical impedance analysis as a method of body composition
- McIver CM, Wycherley TP, Clifton PM. MTOR signaling and ubiquitin-proteosome gene expression in the preservation of fat free mass following high protein, calorie restricted weight loss. Nutr Metab (Lond). 2012 Sep 14;9(1):83. doi: 10.1186/1743-7075-9-83.
- Pleticosic-Ramírez Y, Mecías Calvo M, Navarro-Patón R. Efectos de programas de ejercicio físico en la composición corporal, condición física y calidad de vida de personas mayores con sobrepeso u obesidad: Una revisión sistemática effects of physical exercise programs on body composition, physical fitness and quality of life in older people with overweight or obesity: A systematic review.
- Thomas-Lange J. Sobrepeso y obesidad en chile: Consideraciones para su abordaje en un contexto de inequidad social. Rev chil nutr. 2023;50(4):457. doi: 10.4067/s0717-75182023000400457.
- Moorehead MK, Ardelt-Gattinger E, Lechner H, Oria HE. The validation of the Moorehead-Ardelt Quality of Life Questionnaire II. Obes Surg. 2003 Oct;13(5):684-92. doi: 10.1381/096089203322509237.
- Cancino-Ramirez J, Troncoso-Ortiz EJ, Pino J, Olivares M, Escaffi MJ, Riffo A, Podesta D I, Vasquez M M, Gonzalez-Rojas L. [Exercise and physical activity in adults who underwent bariatric surgery. Consensus document]. Rev Med Chil. 2019 Nov;147(11):1468-1486. doi: 10.4067/S0034-98872019001101468. Spanish.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- CEC CBS /4-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data (IPD) will not be publicly shared to protect patient confidentiality. Only aggregated and anonymized results will be disseminated through scientific publications or presentations.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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