- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07861282
Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer. (TEPUL)
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)?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: David Ortega Valle, PT, MSc
- Numéro de téléphone: +34 663616650
- E-mail: davortval@alum.us.es
Sauvegarde des contacts de l'étude
- Nom: María Jesús Casuso Holgado, PT, PhD
- Numéro de téléphone: +34 659213135
- E-mail: mcasuso@us.es
Lieux d'étude
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Andalusia
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Seville, Andalusia, Espagne, 41009
- Recrutement
- Hospital Universitario Virgen Macarena
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Contact:
- David Ortega Valle, PT, MSc
- Numéro de téléphone: +34 663616650
- E-mail: davortval@alum.us.es
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Chercheur principal:
- María Jesús Casuso Holgado, PT, PhD
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Sous-enquêteur:
- David Ortega Valle, PT, MSc
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Soins habituels
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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. |
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Comparateur actif: Telerehabilitation + Usual Care
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional capacity measured by the One-Minute Sit-to-Stand Test (1MSTS)
Délai: Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
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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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dyspnea measured by the Modified Medical Research Council (mMRC) Dyspnea Scale.
Délai: Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
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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).
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Physical activity level measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF), MET-minutes/week.
Délai: Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
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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).
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Incidence of postoperative pulmonary complications defined by the European Perioperative Clinical Outcome (EPCO) criteria.
Délai: From hospital discharge to 12-week follow-up.
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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.
|
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Health-related quality of life measured by the EQ-5D-5L descriptive system (index value).
Délai: Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
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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).
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Self-rated health measured by the EuroQol Visual Analogue Scale (EQ-VAS).
Délai: Baseline (pre-surgery), 8 weeks (post-intervention), and 12 weeks (4-week follow-up).
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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).
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: María Jesús Casuso Holgado, University of Seville
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Maladies pulmonaires
- Troubles respiratoires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Signes et symptômes respiratoires
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Tumeurs pulmonaires
- Dyspnée
- Complications postopératoires
Autres numéros d'identification d'étude
- ECA-TR-CP-26
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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