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Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer. (TEPUL)

2026年10月15日 更新者:Maria Jesus Casuso-Holgado、University of Seville

Impact of a Therapeutic Exercise Program Delivered Through Telerehabilitation on Postoperative Recovery in Patients Diagnosed With Lung Cancer (TEPUL): A Randomized Controlled Clinical Trial.

Lung cancer is one of the leading causes of cancer-related morbidity and mortality worldwide. Thoracic surgery remains the treatment of choice for patients with early-stage disease; however, postoperative recovery is frequently associated with reduced functional capacity, decreased physical activity levels, pulmonary complications, dyspnea, and impaired quality of life. Early physiotherapy interventions are recommended to minimize these adverse outcomes, although access to postoperative rehabilitation services remains limited in many healthcare settings, including the Andalusian Public Health System.

Telerehabilitation has emerged as a promising strategy to improve access to rehabilitation services by delivering therapeutic exercise and clinical follow-up remotely. Previous studies have demonstrated that telerehabilitation is safe, effective, and cost-efficient across different clinical populations. However, evidence regarding its effectiveness in patients recovering from lung cancer surgery remains limited.

This single-blind randomized controlled trial aims to compare the effects of an eight-week telerehabilitation program based on therapeutic exercise with usual postoperative care in patients with lung cancer undergoing thoracic surgery. Participants allocated to the intervention group will receive 24 therapeutic exercise sessions and 8 online clinical follow-up sessions delivered through the Rehbody platform over an 8-week period. Outcomes will include functional capacity, dyspnea, physical activity level, postoperative pulmonary complications, and health-related quality of life.

The study is designed to address the following research question: In adults with lung cancer undergoing thoracic surgery (Population), does an eight-week therapeutic exercise-based telerehabilitation program (Intervention), compared with usual postoperative care (Comparison), improve postoperative recovery as measured by functional capacity, dyspnea, physical activity level, postoperative pulmonary complications, and quality of life (Outcomes)?

研究概览

详细说明

Lung cancer remains the leading cause of cancer-related mortality worldwide and continues to impose a substantial burden on healthcare systems. Surgical resection is considered the standard treatment for patients with resectable disease and offers the best opportunity for long-term survival. However, despite advances in surgical techniques and perioperative care, recovery following thoracic surgery is frequently characterized by impaired physical function, reduced exercise capacity, dyspnea, decreased physical activity levels, postoperative pulmonary complications, and deterioration in health-related quality of life.

The physical and functional consequences of lung cancer treatment may persist for months or years after surgery and can negatively affect independence, participation in daily activities, and overall well-being. Postoperative rehabilitation and therapeutic exercise have therefore become important components of comprehensive cancer care. Early physiotherapy interventions aim to prevent postoperative pulmonary complications, facilitate recovery of physical function, reduce symptom burden, and promote a safe return to daily activities. Previous studies have shown that exercise-based rehabilitation following lung resection can improve functional capacity and quality of life while reducing postoperative morbidity.

Despite these recognized benefits, access to structured rehabilitation programs remains limited in many healthcare settings due to geographical, logistical, organizational, and resource-related barriers. This challenge is particularly relevant in publicly funded healthcare systems, where rehabilitation services may not be universally available after hospital discharge. As a result, many patients do not receive adequate follow-up rehabilitation during a critical phase of postoperative recovery.

Telerehabilitation has emerged as a promising alternative model of healthcare delivery that enables rehabilitation services to be provided remotely through digital technologies. This approach has the potential to improve accessibility, continuity of care, adherence to prescribed exercise programs, and patient engagement while reducing travel requirements and healthcare costs. Growing evidence supports the safety, feasibility, and effectiveness of telemedicine and telerehabilitation interventions across a variety of chronic and oncological conditions.

In patients with lung cancer, recent studies have reported encouraging results regarding the use of mobile applications and remotely supervised rehabilitation programs. These interventions have been associated with improved adherence to treatment, enhanced functional recovery, better pulmonary function, increased physical activity levels, reduced symptom burden, and improvements in quality of life. Furthermore, digital rehabilitation strategies may facilitate long-term monitoring and support during the postoperative period, helping patients maintain active participation in their recovery process.

Nevertheless, important knowledge gaps remain. The number of high-quality randomized controlled trials specifically evaluating structured postoperative telerehabilitation programs after lung cancer surgery is still limited. Existing studies have often included small sample sizes, heterogeneous interventions, or mixed cancer populations, making it difficult to establish definitive recommendations regarding the optimal design and clinical effectiveness of telerehabilitation in this population. Additional research is needed to determine whether remotely delivered therapeutic exercise programs can produce clinically meaningful improvements in postoperative recovery and patient-centered outcomes.

The present randomized controlled trial has been designed to address this evidence gap by evaluating the effectiveness of an eight-week telerehabilitation program based on therapeutic exercise in patients undergoing thoracic surgery for lung cancer. Participants allocated to the intervention group will receive a structured and progressive exercise program delivered through a dedicated telerehabilitation platform, combined with regular online clinical follow-up sessions. The intervention incorporates aerobic exercise, muscle strengthening exercises, respiratory muscle training, individualized progression, and continuous monitoring of adherence and symptoms. Participants assigned to the control group will receive the usual postoperative physiotherapy care routinely provided after thoracic surgery.

The study will evaluate the impact of the intervention on key dimensions of postoperative recovery, including functional capacity, dyspnea, physical activity levels, postoperative pulmonary complications, and health-related quality of life. Assessments will be performed before surgery, after completion of the intervention period, and following a short-term follow-up period to explore the maintenance of potential benefits.

The findings of this study may contribute to the development of evidence-based rehabilitation pathways for patients recovering from lung cancer surgery. If effective, this telerehabilitation model could represent an accessible, scalable, and cost-efficient strategy for improving postoperative outcomes and expanding access to rehabilitation services within routine clinical practice.

研究类型

介入性

注册 (估计的)

56

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:María Jesús Casuso Holgado, PT, PhD
  • 电话号码:+34 659213135
  • 邮箱:mcasuso@us.es

学习地点

    • Andalusia
      • Seville、Andalusia、西班牙、41009
        • 招聘中
        • Hospital Universitario Virgen Macarena
        • 接触:
        • 首席研究员:
          • María Jesús Casuso Holgado, PT, PhD
        • 副研究员:
          • David Ortega Valle, PT, MSc

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults aged 18 to 80 years.
  • Histologically confirmed primary lung cancer (stage 0 to IIIB).
  • Patients who have undergone thoracic surgery for lung cancer.
  • Medical clearance to participate in an exercise-based rehabilitation program.
  • Ability to understand and communicate verbally.
  • Access to a smartphone and/or computer with internet connection.

Exclusion Criteria:

  • Any medical condition or comorbidity that contraindicates participation in an exercise program.
  • Current psychiatric disorder that may interfere with study participation.
  • Inability to provide written informed consent.
  • Previous thoracic surgery.
  • History of another malignancy within the past one year.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:日常护理

Participants assigned to the control group will receive usual postoperative care routinely provided after thoracic surgery for lung cancer. This includes early mobilization, progressive ambulation according to individual tolerance, deep breathing exercises, active upper-limb and trunk mobility exercises, cough training with wound protection, and discharge recommendations for home-based recovery. No structured telerehabilitation or supervised exercise program will be provided after hospital discharge.

有源比较器:Telerehabilitation + Usual Care

Participants will receive an 8-week telerehabilitation program delivered through the RehBody platform. The intervention includes 24 supervised therapeutic exercise sessions and 8 online clinical follow-up sessions. Exercise sessions incorporate aerobic training, strength exercises, respiratory muscle training, individualized progression, symptom monitoring, and adherence support. Participants will also receive usual postoperative care.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional capacity measured by the One-Minute Sit-to-Stand Test (1MSTS)
大体时间:Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).

Functional capacity will be assessed using the One-Minute Sit-to-Stand Test (1MSTS). Participants will stand up and sit down from a standardized chair as many times as possible within one minute. The total number of completed repetitions will be recorded. There is no fixed maximum value, and higher numbers of repetitions indicate better functional capacity.

Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).

次要结果测量

结果测量
措施说明
大体时间
Dyspnea measured by the Modified Medical Research Council (mMRC) Dyspnea Scale.
大体时间:Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).

Dyspnea will be assessed using the Modified Medical Research Council (mMRC) Dyspnea Scale, a 5-point ordinal scale. Scores range from 0 to 4 (minimum 0, maximum 4). Higher scores indicate greater breathlessness and functional limitation due to dyspnea (worse outcome).

Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
Physical activity level measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF), MET-minutes/week.
大体时间:Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).

Physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Results will be expressed as total MET-minutes/week (metabolic equivalent of task-minutes per week), with a minimum of 0 and no fixed maximum. Higher values indicate a higher level of physical activity (better outcome). Participants will also be categorized as having low, moderate, or high physical activity levels according to the standardized IPAQ scoring protocol.

Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
Incidence of postoperative pulmonary complications defined by the European Perioperative Clinical Outcome (EPCO) criteria.
大体时间:From hospital discharge to 12-week follow-up.

Postoperative pulmonary complications will be collected from clinical records and defined according to the European Perioperative Clinical Outcome (EPCO) criteria. Complications will be recorded from hospital discharge until the end of the intervention and follow-up period. The outcome will be reported as the number and percentage of participants with at least one postoperative pulmonary complication.

From hospital discharge to 12-week follow-up.
Health-related quality of life measured by the EQ-5D-5L descriptive system (index value).
大体时间:Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).

Health-related quality of life will be assessed using the descriptive system of the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), which covers five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with five levels each. Responses will be converted into an index value using a country-specific value set. A value of 1 represents full health and 0 represents a state equivalent to dead; negative values indicate states considered worse than dead, and the minimum depends on the value set used. Higher values indicate better health status (better outcome).

Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
Self-rated health measured by the EuroQol Visual Analogue Scale (EQ-VAS).
大体时间:Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).

Self-rated health will be assessed using the EuroQol Visual Analogue Scale (EQ-VAS), on which participants rate their health on the day of assessment. Scores range from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Higher scores indicate better perceived health status (better outcome).

Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:María Jesús Casuso Holgado、University of Seville

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月8日

初级完成 (估计的)

2028年4月1日

研究完成 (估计的)

2028年11月1日

研究注册日期

首次提交

2026年9月30日

首先提交符合 QC 标准的

2026年9月30日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月21日

上次提交的符合 QC 标准的更新

2026年10月15日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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