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临床试验/NCT07001670
NCT07001670招募中不适用

The Effects of an 8-Week Tele-Yoga Program on Postoperative Recovery in Patients With Lung Cancer Undergoing Lung Resection

Istanbul University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
The Six-Minute Walk Test (6MWT)

研究概览

简要总结

This randomized controlled clinical trial aims to evaluate the effects of an 8-week tele-yoga intervention in individuals with lung cancer who have undergone lung resection surgery. The intervention group will receive supervised yoga sessions via online synchronous video conferencing, while the control group will continue with standard post-operative care. The primary outcome is exercise capacity (6-minute walk test), with secondary outcomes including pulmonary function, respiratory and peripheral muscle strength, physical activity level, dyspnea, fatigue, sleep quality, anxiety and depression, and quality of life. It is hypothesized that tele-yoga will improve physical and psychological recovery post-surgery and may serve as a feasible home-based pulmonary rehabilitation alternative.

详细描述

Lung carcinoma, also referred to as pulmonary carcinoma, is a malignant tumor characterized by uncontrolled cell proliferation in the lung tissue, originating from epithelial cells. It is the most commonly diagnosed cancer type globally. Histopathologically, lung cancer is classified into two main categories: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC constitutes approximately 85% of all lung cancer cases and is associated with high morbidity and mortality. According to the Tumor-Node-Metastasis (TNM) staging system developed by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC), NSCLC is staged from I to IV. While SCLC has a lower prognostic value within the TNM system and is rarely operable, NSCLC is typically treated surgically in early stages.

Surgical treatment for early state of lung cancer includes lobectomy, pneumonectomy, segmentectomy, or wedge resection, depending on tumor location, lung function, and disease stage. The most commonly employed surgical approaches are thoracotomy, video-assisted thoracoscopic surgery (VATS), and robot-assisted thoracoscopic surgery (RATS). Although techniques such as VATS are associated with less postoperative pain, faster recovery, and better preservation of pulmonary function compared to thoracotomy, surgery still significantly reduces exercise capacity and contributes to long-term physical and psychological limitations.

Following lung resection, patients often experience a decline in exercise capacity, attributed to loss of lung parenchyma, ventilatory limitations, increased cardiac workload, thoracic pain, and muscle weakness. Dyspnea is prevalent in up to 60% of postoperative patients, many of whom did not experience dyspnea prior to surgery. Additionally, adjuvant chemotherapy and/or radiotherapy may cause pulmonary inflammation and fibrosis, further reducing lung function and quality of life. Sleep disturbances and psychological disorders such as anxiety and depression are also common during this period.

Exercise training is a non-pharmacological intervention that improves immune function and quality of life in cancer patients; however, traditional pulmonary rehabilitation programs are often underutilized postoperatively. There is increasing interest in mind-body exercise (MBE) modalities such as yoga, tai chi, and qigong, which integrate physical postures, breath control, and meditation. Among these, yoga has shown potential to improve exercise capacity, pulmonary function, muscle strength, fatigue, anxiety, depression, and sleep quality. Despite promising findings, there is a lack of evidence regarding the efficacy of structured yoga interventions specifically tailored for lung cancer patients post-surgery.

Furthermore, the transition from hospital to home poses challenges in ensuring the continuity and accessibility of rehabilitation services. Telehealth, defined as the provision of healthcare services via digital communication technologies, has emerged as a feasible platform for delivering home-based interventions. Tele-yoga, a form of remote supervised yoga practice, has shown benefits in various populations, including those with chronic obstructive pulmonary disease (COPD), heart failure, sleep apnea, and ankylosing spondylitis. However, no study has yet examined its application in post-surgical lung cancer patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessments will be performed by an investigator who is blinded to group allocation.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 18 and 65 years,
  • •Histologically confirmed diagnosis of Stage I-IIIA lung cancer according to the 9th edition of the AJCC Cancer Staging Manual,
  • •Underwent lobectomy, pneumonectomy, segmentectomy, or wedge resection via video-assisted thoracoscopic surgery (VATS) or robot-assisted thoracoscopic surgery (RATS),
  • •An estimated life expectancy of ≥6 months,
  • •Karnofsky Performance Status score greater than 80% at study entry,
  • •Possession of the necessary equipment and access to a stable internet connection to enable participation in online interventions.

排除标准

  • •History of receiving radiotherapy or chemotherapy prior to surgery,
  • •Presence of severe dysfunction in vital organs such as the heart, brain, kidneys, or others,
  • •Having any comorbid condition that contraindicates participation in an exercise training program,
  • •Presence of serious postoperative complications,
  • •Cognitive impairments that hinder effective communication,
  • •Current participation in a structured and regular exercise program,
  • •Missing three consecutive weeks of sessions or completing less than 75% of the prescribed exercises,
  • •Voluntary withdrawal from the study by the participant.

研究组 & 干预措施

Control Group

No Intervention

The control group will not receive any intervention.

Tele-Yoga Group

Experimental

Participants in this arm will receive an 8-week supervised tele-yoga program delivered via real-time video conferencing.

干预措施: Tele-Yoga Training (Other)

结局指标

主要结局

The Six-Minute Walk Test (6MWT)

时间窗: Change from Baseline at 8 weeks

Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society. Functional exercise capacity will be evaluated with the six-minute walk test. Patients will be walked in a 30-meter-long corridor for 6 minutes and the maximum walking distance will be measured. Before and after the test, heart rate, blood pressure and O2 saturation will be measured with pulse oximetry, and dyspnea and fatigue levels will be determined according to the Modified Borg scale.

次要结局

  • Incremental Shuttle Walk Test (ISWT)(Change from Baseline at 8 weeks)
  • 6-Minute Pegboard and Ring Test (6PBRT)(Change from Baseline at 8 weeks)
  • Pulmonary Function Tests (PFT)(Change from Baseline at 8 weeks)
  • Respiratory Muscle Strength Test (MIP/MEP)(Change from Baseline at 8 weeks)
  • Peripheral Muscle Strength (Handgrip Strength Test)(Change from Baseline at 8 weeks)
  • Physical Activity Level (IPAQ-SF)(Change from Baseline at 8 weeks)
  • Dyspnea Assessment (Cancer Dyspnea Scale - CDS)(Change from Baseline at 8 weeks)
  • Fatigue Assessment (Fatigue Severity Scale - FSS)(Change from Baseline at 8 weeks)
  • Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)(Change from Baseline at 8 weeks)
  • Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)(Change from Baseline at 8 weeks)
  • Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30):(Change from Baseline at 8 weeks)
  • Verbal Feedback(Post-intervention (Week 8))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevde Betül Kara, PhD Student

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (1)

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