Preoperative Exercise to Improve Fitness in Patients Undergoing Complex Surgery for Cancer of the Lung or Oesophagus
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in Cardiorespiratory Fitness
研究概览
简要总结
Treatment for people with cancer of the lung or the oesophagus (food-pipe) often involves surgery. This surgery is complex and there is a high risk that patients will develop severe complications afterwards, leading to a longer hospital stay and higher hospital costs, and impacting greatly on recovery and quality of life. If patients' lungs and heart can be optimised before surgery, then recovery may be improved. While fitness can be improved by exercise, the lead-in time to surgery following a cancer diagnosis is often very short, and research is needed to examine what types of exercise might be most effective at increasing fitness over a short period.
This project will investigate if high intensity interval training (HIIT) can increase fitness levels in people scheduled for surgery for cancer of the oesophagus or the lungs. HIIT alternates between periods of high intensity exercise, cycling on a stationary bike, followed by a period of more relaxed exercise. This approach is known to improve fitness but has not previously been investigated in patients awaiting complex cancer surgery.
Groups will be compared for changes in pre-surgery fitness levels, any complications they may experience after surgery, general physical recovery after surgery and the cost of care after surgery. The investigators anticipate that patients who undergo HIIT before surgery will have less complications and better recovery after surgery, a significantly improved quality of life, and lower costs of care.
详细描述
Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery, evaluation of health economics, the impact of the programme on hospital costs.
This study will take the form of a randomised controlled trial aimed primarily at improving pre-operative fitness with high intensity interval training (HIIT). HIIT prescribes aerobic exercise which alternates between periods of high intensity training and active recovery. This form of exercise training stimulates greater improvements in cardiopulmonary fitness over short periods compared to continuous aerobic training and therefore may be ideally suited to exercise prehabilitation. The primary outcome, cardiopulmonary fitness, will be measured by cardiopulmonary exercise testing and explored further using a suite of pulmonary and physical performance measures. Secondary outcomes will examine the impact of individually prescribed HIIT on postoperative outcome, postoperative physical recovery, restoration of pre-treatment fitness levels and both acute and sub-acute hospital costs. The investigators anticipate that this mode of exercise prehabilitation will attenuate postoperative risk and improve postoperative recovery, thus improving patient quality of life and having considerable economic benefits for the healthcare system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double
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
- •Patients who are scheduled for either oesophagectomy (2-stage or 3-stage) or major lung resection for the management of primary oesophageal or lung cancer.
- •Date of surgery ≥ 2 weeks from baseline assessment
- •Ability to provide written informed consent
- •Absence of significant co-morbidities, including metastatic disease, which may adversely impact postoperative outcome
- •Successful completion of a medically supervised cardiopulmonary exercise test
- •Patients with oesophageal cancer scheduled for multimodal therapy including preoperative chemo(radio)therapy and oesophagectomy will be recruited and tested prior to treatment commencement.
排除标准
- •The American Thoracic Society/American College of Chest Physicians (ATS/ACCP) absolute contraindications for exercise testing will be applied.
- •Patients undergoing video assisted lobectomy for early lung cancer will be excluded.
结局指标
主要结局
Change in Cardiorespiratory Fitness
时间窗: At diagnosis (Dx), baseline (T0), immediately post-intervention (T1)
Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
次要结局
- Clavien-Dindo Scale(At hospital discharge (approximately 7-14 days postoperatively))
- Change in the Post-Operative Morbidity Score (POMS)(On postoperative day 5, postoperative day 7 and at hospital discharge (approximately 7-14 days postoperatively))
- The Comprehensive Classification Index (CCI)(At hospital discharge (approximately 7-14 days postoperatively))
- Change in Self reported physical activity: International Physical Activity Questionnaire (IPAQ)(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) as well as post-operative day 30)
- Change in Self reported functional recovery(At post-operative day 30)
- Change in Functional Performance(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1))
- Change in Quality of Life(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.)
- Change in Quality of Life (Specific to Lung Cancer)(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.)
- Change in Pulmonary function(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1))
- Change in Maximum Inspiratory pressure(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1))
- Change in Muscle strength(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1))
- Cost Effectiveness(At routine post-operative clinic visits at 6 weeks and 3 months postoperatively.)
- Change in Quality of Life (Specific to Oesophageal Cancer)(At diagnosis (Dx), baseline (T0), immediately post-intervention (T1) and on post-operative day 30.)
- Qualitative Approach(Immediately after the programme intervention (T1))
研究者
Prof Juliette Hussey
Professor of Physiotherapy
University of Dublin, Trinity College