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Lung cancer remains a leading cause of morbidity and mortality, and resective surgery is the treatment of choice in operable stages. However, a significant proportion of patients present with functional impairment prior to surgery and develop postoperative complications, especially respiratory ones. Prehabilitation has become established as a strategy capable of optimizing physical condition before surgery, while early rehabilitation contributes to accelerating recovery after discharge. Nevertheless, its routine implementation is limited by logistical barriers, short waiting times, and difficulties in accessing in-person care.
The PulmoSalud project proposes a multimodal program, consisting of 8 weeks of prehabilitation (strength and endurance exercises, and respiratory physiotherapy) and 4 weeks of early home-based rehabilitation, supported by a specific digital application, in order to facilitate continuity of care without the need for additional travel. The content includes progressive strength training, structured breathing exercises (including inspiratory muscle training), educational guidelines, and digital recording of activity and symptoms. Patients will receive initial in-person training to ensure the correct execution of the exercises, and will subsequently continue independently with remote supervision.
A controlled study will be conducted comparing this program with the center's standard care. Functional variables (aerobic capacity, muscle strength), respiratory parameters, postoperative complications, quality of life, self-efficacy, and healthcare resource utilization will be evaluated. Measurements will be taken at three time points: baseline (T0), immediate pre-surgical (T1), and one month post-surgery (T2).
PulmoSalud aims to improve preoperative preparation, accelerate post-surgical recovery, and reduce the burden on healthcare services by safely integrating a home-based intervention supported by digital technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Prehabilitation and postoperative rehabilitation. The prehabilitation phase, lasting 8 weeks, includes a supervised, in-person program of progressive, individualized physical exercise (strength, endurance, and neuromuscular training), along with specific respiratory training designed to prepare the patient for the postoperative period. During this stage, physiotherapists teach and practice with the patient all the breathing, ventilation, and secretion management techniques that they will later perform independently. After surgery, the rehabilitation phase begins, lasting 4 weeks and conducted entirely at home to facilitate early intervention and avoid travel. In this stage, the patient applies the previously learned breathing exercises, adapted to their clinical progress, while receiving remote monitoring and adjustments from the research team. |
|
| Control Group | No Intervention | Standard Care PREHABILITATION: Participants will receive standard care provided by the center, including the usual clinical recommendations of the thoracic surgery and oncology team. They will remain on the waiting list for lung cancer surgery according to the standard care pathway, without a structured exercise program, scheduled respiratory physiotherapy, or use of the mobile application. EARLY REHABILITATION Following surgery, participants assigned to the control group will receive standard care provided by the thoracic surgery service, following the center's standard clinical protocols. They will not participate in a structured respiratory physiotherapy program or a supervised exercise plan, and will not have telehealth support or follow-up via a mobile application. Their recovery will proceed according to the standard recommendations of the care team, including pain management. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized pre-operative physical exercise | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk test (6MWT): continuous quantitative variable (meters). | From the start of treatment until its completion at 12 weeks | |
| 30-Second Sit-to-Stand Test | From the start of treatment until its completion at 12 weeks | |
| FEV1 (L and % predicted) | From the start of treatment until its completion at 12 weeks. | |
| FVC (L and % predicted) | From the start of treatment until its completion at 12 weeks. | |
| FEV1/FVC: | From the start of treatment until its completion at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) | From the start of treatment until its completion at 12 weeks. | |
| Peak Cough Flow (PCF) | From the start of treatment until its completion at 12 weeks. |
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Inclusion Criteria:
1. Absolute medical contraindications to supervised physical exercise, such as unstable angina, recent decompensated heart failure, uncontrolled arrhythmias, or acute cardiovascular events within the last 3 months.
2. Very advanced chronic lung disease that prevents participation in the program (e.g., severe COPD with FEV1 < 30% predicted, as determined by the clinical team).
3. Distant metastases or metastatic cancer that contraindicate surgery with curative intent.
4. Planned palliative surgery or life expectancy < 3 months.
5. Home oxygen therapy with severe, uncorrectable hypoxemia, as determined by clinical judgment.
6. Moderate-to-severe cognitive, neurological, or psychiatric impairment that prevents understanding of the study or proper use of the mobile application. 7. An insurmountable language barrier that prevents understanding the study information or using the mobile application.
8. Pregnancy.
9. Participation in another interventional clinical trial that may interfere with the study objectives or its primary outcome.
10. Any other condition that, in the opinion of the research team, compromises the participant's safety or adherence to the protocol.
Withdrawal Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MarÃa Jesús Viñolo Gil, Physiotherapy Doctor | Contact | 609072670 | mariajesus.vinolo@gm.uca.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 12, 2025 |
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|
| Post-operative rehabilitation physical exercise | Other |
|
|
| Respiratory physiotherapy Prehabilitation | Other | Re-education and control of the respiratory pattern, Lung expansion exercises (EDIC) and segmental ventilation, Basic secretion management techniques, Scar protection education and cough management (videos + daily practice), Thoracic mobility and gentle non-impact physical activity, Inspiratory muscle training (IMT), Mobile application (App) for support during postoperative rehabilitation. |
|
| Supporting mobile application (App) | Device | The app will be used as an educational tool and for self-monitoring by the patient, allowing them to record basic parameters daily, such as dyspnea (Borg scale), pain, sleep quality, and adherence to exercise sessions, IMT (Inspiratory Muscle Training), and breathing exercises. The app includes demonstration videos of breathing techniques, education on scar protection, and preoperative preparation materials, as well as scheduled notifications for IMT, chest expansion exercises, and physical activity, in addition to brief self-assessment quizzes. The app's use will be exclusively educational and to support self-management, without remote monitoring or transmission of clinical data to the healthcare team. |
|
| Home-based respiratory physiotherapy | Other | Re-education and control of the breathing pattern, Lung expansion exercises and directed ventilation, Safe bronchial hygiene techniques, Scar protective education and effective pain-free coughing strategies, Inspiratory muscle training, Whole body ventilatory training. |
|
| mMRC scale | From the start of treatment until its completion at 12 weeks. |
| modified Borg scale | From the start of treatment until its completion at 12 weeks. |
| Hand grip dynamometry | From the start of treatment until its completion at 12 weeks. |
| Estimated maximum strength 1RM | From the start of treatment until its completion at 12 weeks |
| Bruce's ramp test | From the start of treatment until its completion at 12 weeks |
| Submaximal heart rate reached (80%, heart rate monitor) | From the start of treatment until its completion at 12 weeks |
| FAACT-A/CS Questionnaire (anorexia-cachexia) | From the start of treatment until its completion at 12 weeks |
| diet quality | From the start of treatment until its completion at 12 weeks |
| International Physical Activity Questionnaire (IPAQ) | From the start of treatment until its completion at 12 weeks |
| Godin questionnaire | From the start of treatment until its completion at 12 weeks |
| Subjective perception of effort (RPE, scale 0-10) | From the start of treatment until its completion at 12 weeks |
| Mar 12, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| D015438 | Health Behavior |
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