Clinical trial NCT07001670: Investigation of the Effects of Tele-Yoga Training in Individuals With Lung Cancer Undergoing Lung Resection Surgery
Official title: The Effects of an 8-Week Tele-Yoga Program on Postoperative Recovery in Patients With Non-Small Cell Lung Cancer Undergoing Lung Resection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Neoplasms, Non-Small Cell Lung Cancer
Postoperative Period
Keywords: Exercise capacity
Pulmonary function
Muscle Strength
Dyspnea
Fatigue
Anxiety
Depression
Quality of Life
Exercise Therapy
Telemedicine
Rehabilitation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial aims to evaluate the effects of an 8-week tele-yoga intervention in individuals with non-small cell lung cancer (NSCLC) 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.

Detailed description: 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 NSCLC 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 NSCLC 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 NSCLC patients.

Based on this gap in the literature, the present study aims to investigate the effects of an 8-week synchronized tele-yoga intervention on exercise capacity, pulmonary function, respiratory and peripheral muscle strength, physical activity level, dyspnea, fatigue, sleep quality, anxiety, depression, and health-related quality of life in patients who have undergone lung resection surgery for NSCLC. This will be the first randomized controlled trial to assess a comprehensive yoga-based telerehabilitation approach in this population. The findings may provide a cost-effective and practical home-based rehabilitation strategy to enhance physical and psychological recovery in lung cancer survivors.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years,
* Histologically confirmed diagnosis of Stage I-IIIA non-small cell lung cancer (NSCLC) according to the 7th edition of the AJCC Cancer Staging Manual,
* Underwent lobectomy, pneumonectomy, segmentectomy, or wedge resection via thoracotomy or video-assisted thoracoscopic surgery (VATS),
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Six-Minute Walk Test (6MWT)
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Incremental Shuttle Walk Test (ISWT)
timeFrame: Change from Baseline at 8 weeks
measure: 6-Minute Pegboard and Ring Test (6PBRT)
timeFrame: Change from Baseline at 8 weeks
measure: Pulmonary Function Tests (PFT)
timeFrame: Change from Baseline at 8 weeks
measure: Respiratory Muscle Strength Test (MIP/MEP)
timeFrame: Change from Baseline at 8 weeks
measure: Peripheral Muscle Strength (Handgrip Strength Test)
timeFrame: Change from Baseline at 8 weeks
measure: Physical Activity Level (IPAQ-SF)
timeFrame: Change from Baseline at 8 weeks
measure: Dyspnea Assessment (Cancer Dyspnea Scale - CDS)
timeFrame: Change from Baseline at 8 weeks
measure: Fatigue Assessment (Fatigue Severity Scale - FSS)
timeFrame: Change from Baseline at 8 weeks
measure: Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
timeFrame: Change from Baseline at 8 weeks
measure: Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
timeFrame: Change from Baseline at 8 weeks
measure: Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30):
timeFrame: Change from Baseline at 8 weeks
measure: Verbal Feedback
timeFrame: Post-intervention (Week 8)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Thoracic Surgery, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Rengin Demir, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Akif Turna, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Sevde B Kara, PhD student
role: PRINCIPAL_INVESTIGATOR
References: