Effects of Early Pulmonary Rehabilitation and Long-term Exercise on Functioning, Quality of Life and Postoperative Outcome in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in 6 Minutes Walking Test
研究概览
简要总结
Lung cancer is the leading cause of cancer death in males, and is increasing in females. Up to 73% of affected patients present with Chronic Obstructive Pulmonary Disease (COPD). Most lung cancer patients have an average survival of about 8 months from diagnosis. Lobectomy for initial stages has demonstrated higher survival rates, but only 15% to 25% are surgical candidates; unfortunately, cardiopulmonary impairment mainly due to coexisting COPD reduces this number and patients undergo medical treatment or marginal lung resection, with minor functional impact but possible ineffective control of disease.
Furthermore, COPD is associated with increased postoperative morbidity and mortality, longer in-hospital stay, need for additional treatments, and a rise in sanitary costs.
The investigators planned a randomised trial on surgical candidates to assess the effect of comprehensive pulmonary rehabilitation on functional and surgical outcomes, functioning, and Quality of Life (QoL).
详细描述
Preoperative pulmonary rehabilitation ameliorates functional parameters responsible for inoperability in COPD patients; candidates for surgery could benefit from this functional improvement in terms of wider possible lung resection and lower incidence of postoperative complication.
Likewise, postoperative respiratory rehabilitation significantly improves respiratory function and exercise capacity in treated patients but the effect on long-term functioning and QoL is not known.
Current studies present small-sized samples and short follow up. The impact of comprehensive rehabilitation on overall functioning, depression, pain, and QoL has only been reported for COPD patients. Moreover, the rate of anatomical resection and postoperative morbidity in compromised COPD patients treated with intensive rehabilitation has never before been reported in randomised trials.
The investigators hypothesise that: comprehensive rehabilitation intervention in lung cancer patients eligible for surgical treatment may reduce pain, comorbidity (pneumonia and other pulmonary complications requiring further treatments), depression, and deconditioning and improve QoL 1 to 6 month after surgery; active lifestyle and regular follow up may reduce long-term quality of life decline; early pulmonary rehabilitation can improve lung function tests making proper surgical treatment with curative intent possible in patients affected by COPD otherwise treated medically or by marginal operations.
Investigators have planned a randomised trial with 2 parallel arms: all patients with resectable (T1-2 N0-1) diagnosed or suspected lung cancer will be enrolled in the study at pre-operative interview with thoracic surgery consultant and then randomised by the physician data manager (T0). The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions. Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR. Both groups will receive re-evaluation and, if necessary, optimization of COPD therapy before entering the study; final follow up will be at 6 months after surgery in both groups (T3), intermediate evaluations are planned immediately before surgery (T1) and 1 month after surgical treatment (T2).
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage 1 to 2B diagnosed or suspected NSCLC in operable patients
排除标准
- •unresectable disease, N2 disease requiring induction or postoperative chemotherapy
- •patients unfit for physical exercise requested by rehabilitation and assessments
结局指标
主要结局
Change in 6 Minutes Walking Test
时间窗: Baseline, Preoperative, 1 month, 6 month
6MWT
次要结局
- Change in Pulmonary Function Tests(Baseline, Preoperative, 1 month, 6 months)
