- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01751880
Safety, Feasibility and Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Pilot Study
Gastric cancer is a major health issue and one of the most common malignance in Korea. With the popularization of cancer screenings and increasing the average lifespan, the number of gastric cancer patients is increased. In the past, most of the research were concerned with survival and recovery after cancer surgery. However, as the medical technology had been developed and recovery rate and survival rate of cancer patients had risen, the patients wanted to return to a daily life and desire for participation for leisure. In other words, the patients who underwent surgery wants to maintain a high quality of life(QOL) level as like prior to cancer surgery.
There are many reports on the effect of the exercise program after cancer surgery. In addition, exercise program was associated with improving the QOL and functional recovery, decreasing a mood of depression, maintaining a muscle mass and improving the survival rate.
However, the subject patients of previous studies were Western people. Therefore, The results were not disclosed whether the exercise program suited to the body characteristics of Korean people. Furthermore there was no exercise program studies for the gastric cancer patients.
Medical service for cancer patients care should include not only diagnosis, treatment as like surgery but efforts on enhancing the quality of life. In other words, post-management education and management program as like exercise program are necessary for the cancer patients after surgery. So, the research about how to practice the exercise program and how to evaluate the effect on the recovery is needed.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Seoul, Corea, Repubblica di, 120-752
- Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Early gastric cancer patients
- Undergoing minimally invasive surgery
- AGE: 20-70
- ECOG: 0-1
- A patient who did not exercise regularly for the last 6 months
- A patient who signed the informed consent
Exclusion Criteria:
- Pregnancy or plans to become pregnant
- Cognitive disabilities
- Other primary cancer history
- History of major abdominal surgery except current surgery
- Cardiopulmonary medical comorbidity
- Living > 60 km from the hospital
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Gruppo di esercizi
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Exercise program is scheduled to be conducted in three phases.
Phase I is in-hospital exercise program.
This program will be conducted in hospital during 1 week after surgery.
Phase II is home-exercise program that will be performed at home during 1 week after discharge.
Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program.
Main-exercise program is focused on the functional recovery.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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changes of result of blood sample test, cardio pulmonary function test and vital signs reflecting of inflammation level and nutrition condition in patients with minimally invasive gastrectomy
Lasso di tempo: 2 weeks and 10 weeks after gastrectomy
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2 weeks and 10 weeks after gastrectomy
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Collaboratori e investigatori
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Inizio studio (Effettivo)
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Completamento dello studio (Effettivo)
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Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 4-2012-0221
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .