Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05959226
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-25
First Post:
2023-07-17
Brief Title:
Effect of Exercise and Enteral Nutrition on Survival
Sponsor:
The First Hospital of Jilin University
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Effect of Exercise and Enteral Nutrition Intervention on Survival in Patients With Locally Advanced Gastric Cancer a Prospective Multicenter Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENERGY
Brief Summary:
The present clinical trial was designed to explore the effect of postoperative physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer
Detailed Description:
The present clinical trial was designed to explore the effect of physical exercise combined with enteral nutritional supplement on 3-year disease-free survival in patients with advanced gastric cancer In the trial group comprehensive postoperative management model with targeted exercise intervention and nutritional support The details are as follows
1 Nutrition intervention From discharge 7-14 days after surgery until 6 months after surgery patients are required to take 400 kcalday of enteral nutrition supplement ONS in addition to their normal diet Once the patients oral diet decreases ONS will be added several times a day to ensure that the total energy reaches the ESPEN recommended daily 30 kcalkg The daily protein requirement is set at 12-15 gkg of actual body weight The Dietitian will keep records and help patients adjust their energy intake weekly
2 Exercise under the guidance of the rehabilitation therapist the patient gradually recovers Exercise from discharge 7-14 days after the operation to 6 months after the operation and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week The control group patients received the same baseline evaluation as the experimental group patients The control group will not receive phisical exercise intervention but will receive postoperative nutritional treatment with the same standards as the experimental group
1 Nutrition intervention From discharge 7-14 days after surgery until 6 months after surgery patients are required to take 400 kcalday of enteral nutrition supplement ONS in addition to their normal diet Once the patients oral diet decreases ONS will be added several times a day to ensure that the total energy reaches the ESPEN recommended daily 30 kcalkg The daily protein requirement is set at 12-15 gkg of actual body weight The Dietitian will keep records and help patients adjust their energy intake weekly
2 Exercise under the guidance of the rehabilitation therapist the patient gradually recovers Exercise from discharge 7-14 days after the operation to 6 months after the operation and should ensure at least 150 minutes of moderate intensity exercise or a combination of equivalent activities per week The control group patients received the same baseline evaluation as the experimental group patients The control group will not receive phisical exercise intervention but will receive postoperative nutritional treatment with the same standards as the experimental group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None