TRIMODAL PREHABILITATION PROGRAM IN PATIENTS WITH GASTROINTESTINAL CANCER DURING NEOADJUVANT TREATMENT: A PILOT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Demonstrate the feasibility of a trimodal prehabilitation program with motivational strategies during chemotherapy in a multidisciplinary hospital setting.
研究概览
简要总结
Digestive cancers account for a substantial proportion of oncological patients, representing over 20% of cases treated in hospitals, and are generally managed through a multidisciplinary approach that has markedly improved survival outcomes over recent decades. Surgical resection remains the cornerstone of curative treatment, often preceded by neoadjuvant chemotherapy, radiotherapy, or combined modalities. Notably, a significant proportion of patients eligible for abdominal surgery are older adults, with approximately one in three being over 75 years of age. Advances such as Enhanced Recovery After Surgery (ERAS) protocols and the centralization of complex surgical procedures have contributed to better outcomes, including higher rates of radical resections, improved survival, reduced postoperative complications, and shorter hospital stays.
While some risk factors are non-modifiable, such as age, sex, tumor stage, comorbidities, and tumor biology, several modifiable factors can be optimized prior to surgery to improve postoperative outcomes. These include smoking cessation, enhancement of aerobic capacity and muscular strength, nutritional optimization, emotional resilience, and correction of anemia or other metabolic derangements. Preoperative exercise, ideally embedded within a multimodal prehabilitation program, is recommended for all patients undergoing major surgery. The neoadjuvant period represents a valuable window to implement trimodal prehabilitation strategies encompassing physical exercise, nutritional support, and psychological interventions, aimed at reducing postoperative complications, shortening hospital length of stay, and improving functional recovery.
Physical fitness in this context is multidimensional, encompassing aerobic capacity, muscle strength, and body composition. Aerobic capacity predicts postoperative complications and length of hospital stay, while low muscle strength and sarcopenia are associated with higher morbidity and poorer prognosis. Inspiratory muscle training can further reduce pulmonary complications and accelerate recovery. Nutritional status is a critical determinant of surgical outcomes in gastrointestinal cancer, with malnutrition affecting up to 80% of patients at diagnosis. Comprehensive assessment, including dietary intake, anthropometric measurements, physical examination, and biomarkers such as albumin and transferrin, is essential, and targeted interventions including protein supplementation, pancreatic enzyme replacement, or tailored dietary strategies should be implemented when indicated. Body composition, particularly sarcopenia and cachexia, is closely linked to both nutrition and exercise, and can be assessed through imaging techniques such as DXA, CT, or MRI, or via bioelectrical impedance in research settings, with simpler bedside assessments used in clinical practice.
Emotional wellbeing also plays a significant role, as preoperative anxiety and depression can negatively influence recovery, adherence to rehabilitation, and overall quality of life. Psychological support, stress management, and behavioral interventions can improve patient engagement and enhance outcomes. The physiological principles of hormesis and cross-stressor adaptation suggest that controlled exercise can improve resilience to both physical and psychological stressors, including the stress of surgery itself. Additional modifiable factors such as absolute cessation of alcohol and tobacco, glycemic control in diabetic patients, correction of anemia (including iron deficiency), and frailty assessment in older adults are critical components of preoperative optimization.
Major abdominal surgery carries substantial risk, including infections, bleeding, and anastomotic complications, which directly impact quality of life and lengthen hospitalization. Evidence from randomized controlled trials indicates that multimodal prehabilitation effectively reduces postoperative complications and shortens hospital stay. However, motivating patients to engage in exercise during neoadjuvant therapy can be challenging due to treatment-related fatigue, nausea, and other side effects. Integrating behavioral theories such as Self-Determination Theory and the Theory of Planned Behavior can enhance intrinsic motivation by fostering autonomy, competence, and relatedness, and addressing attitudes, subjective norms, and perceived behavioral control, ultimately promoting adherence to prehabilitation programs and optimizing postoperative recovery.
详细描述
9. INTERVENTION PHYSICAL PREHABILITATION PROGRAMME Prior to the intervention, a complete physical assessment will be carried out. In addition, a motivational interview will be conducted, which is a promising technique for addressing many types of behavioural changes in cancer patients or survivors.
The training will consist of two main components (cardiorespiratory endurance and muscle strength) and two secondary components (flexibility and balance). A plan will be followed to increase the intensity of the training in relation to the patients' tolerance and functional capacity.
AEROBIC EXERCISE: A frequency of at least 5 days per week should be achieved in the case of moderate exercise and at least 2 days in the case of vigorous exercise, aiming for a total of 150-300 minutes of moderate-vigorous physical activity or 75-150 minutes in the case of vigorous activity (WHO, 2020). Moderate intensity is considered to be training at 40-59% of peak oxygen consumption reserve (the difference between consumption at maximum exercise and at rest), or training at 55-69% of maximum HR or 6-7 on the Borg scale. Vigorous intensity is considered to be training at 60-84% of peak oxygen consumption, or training at 70-89% of maximum HR or 8-9 on the Borg scale.
The type of aerobic exercise will differ depending on the stage of the patient's treatment and their tolerance. When exercising independently, they can do most of the exercise by walking and cycling (which trains the large muscle groups). If their physical condition allows it, they could do interval training. If the patient tolerates it, the intensity can be increased, but it must be remembered that as they progress in training, they also progress in chemotherapy treatment and their tolerance to exercise decreases.
In the supervised part, the training methodology will be varied (i.e. circuits with different activities, games, etc.) in order to avoid monotony and boredom, which have been linked to lower motivation to engage in physical activity. In any case, training will be planned and periodised on a day-to-day basis in order to adapt the training sessions to the individual needs of each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old
- •Being able to complete the mile-time test
- •Stages I-III
- •Being able to understand the informed consent
- •Gastrointestinal cancer diagnosed
排除标准
- •Metastatic cancer
结局指标
主要结局
Demonstrate the feasibility of a trimodal prehabilitation program with motivational strategies during chemotherapy in a multidisciplinary hospital setting.
时间窗: 1 year
Feasibility will be assessed based on the rejection rate (\<50%) and adherence (\>50%). Adherence will be considered according to the training options. There are two sessions per week (attendance at four sessions in a 15-day cycle, 100%, etc.).
次要结局
- Changes in (estimated) cardiorespiratory fitness(3-6 months (from 1st treatment to surgery))
- Changes in muscle strength(3-6 months (from 1st treatment to surgery))
- Changes in body composition(3-6 months (from 1st treatment to surgery))
- Changes in levels of physical activity at week(3-6 months (from 1st treatment to surgery))
- Changes in quality of life(3-6 months (from 1st treatment to surgery))
- Changes in fatigue levels(3-6 months (from 1st treatment to surgery))
- Dose intensity in neoadjuvant treatment(three months)
- Describe post-surgical complications(3-6 months (from 1st treatment to surgery))
- Describe psychological status(3-6 months (from 1st treatment to surgery))
- To describe body composition(3-6 months (from 1st treatment to surgery))
- Percentage of pathological complete responses(4-6 weeks after surgery)
- Hindrances and facilitators of patients(3-6 months (from 1st treatment to surgery))
研究者
Ana Ruiz-Casado
PRINCIPAL INVESTIGATOR
Puerta de Hierro University Hospital
