Feasibility of Supervised Home-based Exercise Prehabilitation in Patients Scheduled for Pancreatic Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Adverse events
研究概览
简要总结
Rationale: The complication rate after pancreatic resection is high, especially in elderly and physically unfit patients. Aerobic capacity, as indicated by the ventilatory anaerobic threshold (VAT) assessed by a cardiopulmonary exercise test (CPET), can be used to identify high-risk patients. Previous studies have demonstrated that exercise prehabilitation can increase aerobic capacity in patients scheduled for intra-abdominal surgery, subsequently leading to better treatment outcomes. There is limited evidence on the feasibility of a (partly) supervised home-based prehabilitation program in patients scheduled for pancreatic resection.
Objective: The primary objective of this study is to assess the feasibility of a four-week supervised home-based prehabilitation program in patients scheduled for elective pancreatic resection. Secondary objectives are to evaluate individual responses to prehabilitation on a number of secondary endpoints (no cause-effect relationship to be established).
Study design: This study is a pragmatic multicenter study with a pretest-posttest design. It will take place at the Maastricht University Medical Center+ and University Medical Center Groningen in the Netherlands, and at the 'Città della Salute e della Scienza' in Torino, Italy.
Study population: Patients planned for elective resection of a pancreatic tumor will be screened for potential eligibility. High-risk patients, identified by an oxygen uptake (VO2) at VAT ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min, will be asked to participate.
Intervention: A total of 45 patients will participate in a four-week (partly) supervised home-based personalized exercise training program before surgery (12 sessions in total). An advanced cycle ergometer (Lode Corival, Lode BV, Groningen, the Netherlands) will be delivered at the patient's home. Three weekly sessions of high-intensity interval training on the cycle will be combined with functional task exercise training. A trained physical therapist will visit the patient at least weekly to monitor progress.
Main study parameters: The main study parameter is feasibility of the (partly) supervised home-based prehabilitation program. Hereto participation rate and reasons for non-participation will be evaluated. In participating patients, adherence/compliance, dropout rate, reasons for dropout, adverse events, patient motivation, and patient and therapist appreciation will be assessed throughout the program.
Secondary endpoints: Secondary endpoints before and after prehabilitation include aerobic capacity, muscle function, body composition, functional mobility, immune system function, perceived fatigue, quality of life, and sarcopenia. Data on patient characteristics, neoadjuvant therapy, surgical procedure, and postoperative outcomes will also be collected for explorative purposes.
详细描述
As the aging population grows, the incidence of malignancies of the pancreas will also rise. Surgery is an important treatment modality; at the same time, it is a challenge (allostatic load) for the patient's homeostasis. Age- and disease-related psychophysiological changes and comorbidities affect tolerance to surgery (adaptive capacity). Prehabilitation may increase a patient's ability to cope with surgical-induced allostatic load by improving the capacity and functioning of the respiratory, cardiovascular, and/or musculoskeletal systems, and therefore lower the risk of postoperative morbidity and mortality.
About 28% of patients undergoing pancreatic resection developed a major complication (Clavien-Dindo grade III or higher), and 3.2% deceased in-hospital in the Netherlands between 2014 and 2017. Older patients, especially physically unfit patients, are more prone to complications.
Preoperative aerobic capacity has been found to have a consistent relationship with postoperative outcome in major elective intra-abdominal surgery, such as pancreatic resection. Previous studies consistently indicated that an oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) <11mL/kg/min and/or a VO2 at peak exercise (VO2peak) <18mL/kg/min, as determined during a cardiopulmonary exercise test (CPET), are cut-off points to identify patients that have a higher risk for postoperative morbidity and mortality. Exercise prehabilitation has been reported to be able to preoperatively increase the physical fitness of patients scheduled for elective intra-abdominal surgery, of which high-risk patients will benefit the most. Most prehabilitation programs were carried out under supervision in an outpatient clinic. Often however, patients are not able or willing to participate, for example because of travelling issues or because it is becoming 'too much'. Home-based programs are often unsupervised and lack the ability to monitor adherence of the patient, and therefore might lack effectiveness.
A personalized exercise program in a home-based setting might enhance the participation rate, motivation, and adherence of patients. This has proven to be the preferred method for previous prehabilitation programs. Although several studies investigated the effects of exercise prehabilitation before pancreatic resection and reported positive effects on preoperative physical fitness and postoperative morbidity, there is limited evidence addressing the feasibility and effectiveness of (partly) supervised home-based prehabilitation in these populations. Moreover, effectiveness has not been evaluated using sophisticated outcome measures.
In a recent study in patients planned for liver or pancreatic surgery the adherence rate of a semi-supervised home-based training program was 83%. Furthermore, it led to an increase in VO2 at the VAT of 17.8% and VO2peak of 17.2%. This leads to the hypothesis that a partly supervised home-based prehabilitation program is feasible in a high risk-group. To test this hypothesis further the study will investigate the feasibility of a (partly) supervised prehabilitation program and will focus on patients undergoing pancreatic resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •An oxygen uptake (VO2) at the ventilatory anaerobic threshold (VAT) ≤13 ml/kg/min and/or an VO2peak ≤18 ml/kg/min assessed using cardiopulmonary exercise testing
- •Age ≥18 years
- •Scheduled for elective pancreatic resection at Maastricht UMC+, at the University Medical Center Groningen, or the Citta della Salute e della Scienza Hospital in Torino
- •Willing to participate in the home-based prehabilitation program
- •Providing informed consent to participate
排除标准
- •Patients requiring acute (emergency) surgery;
- •Patients undergoing surgery in another hospital;
- •Patients not living within the catchment area of the hospital (<30 minutes);
- •Patients not capable of cycling on a cycle ergometer;
- •Patients with contraindications for physical exercise training;
- •Unable to cooperate with the testing procedures (e.g., insufficient understanding of the Dutch or Italian language at the Maastricht University Medical Center+, at the University Medical Center Groningen, or at the 'Città della Salute e della Scienza' Hospital in Torino, respectively);
- •No physical therapist with the right education (functional task training/home based prehabilitation) available in the living area of the patient.
结局指标
主要结局
Adverse events
时间窗: 4-week training period
Any undesirable experience occurring to a participant during the study, whether or not considered related to the experimental supervised home-based prehabilitation program
Reasons for non-participation
时间窗: At recruitment
Patient's reasons for non-participation in the prehabilitation program while being eligible
Adherence/compliance
时间窗: 4-week training period
Adherence rate to the prehabilitation program
Reasons for dropout
时间窗: 4-week training period, at moment of drop-out
Participant's reasons for dropping out the prehabilitation program
Patient appreciation
时间窗: at the end of 4-week training period
Patient appreciation measured via an appreciation questionnaire
Therapist appreciation
时间窗: at the end of 4-week training period
Therapist appreciation measured via an appreciation questionnaire
Participation rate
时间窗: At recruitment
Rate of eligible patients that participate in the prehabilitation program
Dropout rate
时间窗: 4-week training period
Dropout rate of the prehabilitation program
次要结局
- Level of perceived fatigue(4 weeks (pre- and post-prehabiltation))
- Body composition(4 weeks (pre- and post-prehabiltation))
- Immune system function(4 weeks (pre- and post-prehabiltation))
- Muscle function(4 weeks (pre- and post-prehabiltation))
- Aerobic capacity(4 weeks (pre- and post-prehabiltation))
- Functional mobility/muscle strength(Weekly during 4-week training period)
- Quality of life measurement(4 weeks (pre- and post-prehabiltation))
研究者
Nicole Hildebrand
PhD-candidate HPB-Surgery
Academisch Ziekenhuis Maastricht