An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial (Gastric cancer)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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. Thus, the investigators have done the pilot study about how to practice the exercise program and how to evaluate the effect on the recovery. Based on the result of pilot study which could identify the safety and the feasibility , the investigators would like to do a prospective randomized controlled study to prove the effect of exercise program after surgery
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Seoul, Korea, Republiken av, 134
- Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Kontrollgrupp
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Experimentell: Exercise group
physical activity intervention
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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QoL(quality of life)
Tidsram: 10 weeks after gastrectomy
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10 weeks after gastrectomy
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Sekundära resultatmått
Resultatmått |
Tidsram |
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cardiopulmonary function test
Tidsram: 10 weeks after gastrectomy
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10 weeks after gastrectomy
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vital signs reflecting of inflammation level
Tidsram: 10 weeks after gastrectomy
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10 weeks after gastrectomy
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nutrition condition
Tidsram: 10 weeks after gastrectomy
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10 weeks after gastrectomy
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 4-2013-0215
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