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Safety, Feasibility and Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Pilot Study

26. november 2017 opdateret af: Yonsei University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 120-752
        • Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Early gastric cancer patients
  2. Undergoing minimally invasive surgery
  3. AGE: 20-70
  4. ECOG: 0-1
  5. A patient who did not exercise regularly for the last 6 months
  6. A patient who signed the informed consent

Exclusion Criteria:

  1. Pregnancy or plans to become pregnant
  2. Cognitive disabilities
  3. Other primary cancer history
  4. History of major abdominal surgery except current surgery
  5. Cardiopulmonary medical comorbidity
  6. Living > 60 km from the hospital

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Træningsgruppe
Adfærdsmæssigt: physical activity intervention
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 2 weeks and 10 weeks after gastrectomy
2 weeks and 10 weeks after gastrectomy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yonsei University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. august 2012

Primær færdiggørelse (Faktiske)

5. november 2013

Studieafslutning (Faktiske)

5. november 2013

Datoer for studieregistrering

Først indsendt

12. december 2012

Først indsendt, der opfyldte QC-kriterier

13. december 2012

Først opslået (Skøn)

18. december 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 4-2012-0221

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mavekræftpatient

Kliniske forsøg med physical activity intervention

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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