Results of a Programme of Intensive Prehabilitation in GEriatric Patients Operated for Colo-Rectal Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of eligible participants completed the personalized proposed prehabilitation program
研究概览
简要总结
This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. The current study is aimed at standardizing a prehabilitation pathway, evaluating its feasibility within the AUSL Romagna in collaboration with the PRIME Centre and the multiple professions that populate the two institutes in the spirit of confirming the beneficial effect of an integrated prehabilitation programme on surgical outcomes.
Patients will follow an intensive prehabilitation course before surgery:
- Colon cancer patients will do 4 weeks of prehabilitation before surgery.
- Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.
The prehabilitation course is structured around the following aspects:
- Frailty assessment and identification of optimisation fields
- Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
- Assessment by an integrative medicine specialist
- Nutritional pre-qualification
- Cardiovascular, respiratory, motor prehabilitation
- Emotional and psychological prehabilitation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •Male/female participants who are at least 70 years of age on the day of signing informed consent.
- •Patients with confirmed diagnosis of colorectal cancer awaiting major surgery.
排除标准
- •Clinical need for emergency intervention.
- •Severe cognitive impairment (MMSE<20*)
- •Severe dependency (ADL<3)
- •Stage IV colorectal neoplasia
结局指标
主要结局
Percentage of eligible participants completed the personalized proposed prehabilitation program
时间窗: 4 months
The primary endpoint of the study will be the feasibility of delivering a prehabilitation program, based on adherence. This study will be deemed as feasible if ≥80% of eligible participants completed the personalized proposed prehabilitation program.
次要结局
- 30-days mortality(30 days after the surgery)
- Postoperative functional recovery at one month after surgery(30 days after the surgery)
- Adherence to prescription(4 months)
- Overall morbidity rate and major morbidity rate(4 months)
- Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery(30 days after the surgery)
- Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery.(30 days after the surgery)