Peri-habilitation to Enhance Treatment Outcomes and Postoperative Recovery in Patients With Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gait speed test
研究概览
简要总结
This study aims to evaluate the clinical applicability of a peri-habilitation program in patients with gastric cancer by applying nutritional intervention for approximately two weeks before surgery and a combined exercise and nutrition intervention for about three weeks after hospital discharge, and by analyzing its effects on the prevention of postoperative complications and recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 65 years or older who have been diagnosed with gastric cancer and are scheduled to undergo surgical treatment or chemotherapy.
排除标准
- •Patients with severe conditions who are unable to undergo the intervention prior to surgical treatment or chemotherapy.
- •Patients with physical (e.g., musculoskeletal) or mental disorders that make participation in or continuation of the program impossible.
- •Patients judged to be at risk of additional physical burden from the intervention.
研究组 & 干预措施
Nutrition (NUT)
Nutrition (NUT) Participants will receive standard clinical care combined with nutrition education and protein-enriched soy milk supplementation for approximately 2 weeks before surgery and about 3 weeks after hospital discharge.
干预措施: nutrition education plus active supplement (Dietary Supplement)
Exercise and Nutrition(EN)
Exercise and Nutrition Group (EN)
Participants will receive peri-habilitation exercise training in combination with nutritional intervention, including carbohydrate plus protein-enriched soy milk supplementation twice daily (before and after exercise), for approximately 2 weeks before surgery and about 3 weeks after hospital discharge.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Gait speed test
时间窗: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time to walk 4 meters (or 3 meters) at a normal, comfortable pace. * Seconds(sec) * Lower values(seconds) indicate better performance (faster walking speed)
Chair stand test
时间窗: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time to stand up and sit down 5 times from a chair without using the arms. * Seconds(sec) * Lower values(seconds) indicate better performance.
Balance test
时间窗: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time maintaining balance in three positions (feet together, semi-tandem, and tandem stance). The maximum time allowed for each position is 10 seconds. * Seconds(sec) * Higher values(seconds) indicate better performance.
Timed up and go test
时间窗: Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery
* Time to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. * Seconds(sec) * Lower values(seconds) indicate better performance.
次要结局
- Electrocardiogram(ECG)(Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery)
- Inflammation and Oxidative Stress Markers (Blood Analysis)(Baseline (2 weeks before surgery) Preoperative hospitalization (1-4 days before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery)
- Hospital Anxiety and Depression Scale (HADS)(Baseline (2 weeks before surgery) Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery)
- Quality of life(KOQUSS-32, KOQUSS-40)(Baseline (2 weeks before surgery) 3 weeks after discharge 6 months after surgery)
- Clavien-dindo classification(Postoperative discharge (at hospital discharge) 3 weeks after discharge 6 months after surgery)
研究者
Min, Jae-Seok
Assistant Professor of Surgery
Korea University Anam Hospital