PulmoSalud: Multimodal Program for Prehabilitation and Early Home Rehabilitation in Patients With Lung Cancer

Обзор

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.

Вмешательства

• Другое Individualized pre-operative physical exercise
  1. Warm-up and mobility (8-10 minutes): Overall mobility of the spine, shoulder girdle, and hips; light walking or cycling; progressive muscle activation. 2. Aerobic training (12-20 minutes): Options include walking, treadmill, or stationary cycling. Moderate intervals (light HIIT). 3. Strength training (15-25 minutes): Performed with resistance bands, light dumbbells, and bodyweight exercises, with special emphasis on the lower limbs and relevant scapular muscles following thoracic surgery: ass
• Другое Post-operative rehabilitation physical exercise
  1. Initial recovery: Light walking 10-15 min/day, RPE 2-3, very basic strength exercises (1 set): Supported sit-to-stand, lateral walking, gentle scapular retraction, strengthening of thoracic mobility, and breathing exercises from the clinical protocol. 2. Progressive functional recovery: Walking 15-25 min/day, RPE 4-5, introduction of light intervals (30 seconds fast / 90 seconds slow), strength circuit (2 sets): Assisted squat, banded row, hip thrust, add scapular work as tolerated.
• Другое Respiratory physiotherapy Prehabilitation
  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.
• Устройство Supporting mobile application (App)
  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 acti
• Другое Home-based respiratory physiotherapy
  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.

Первичные конечные точки

• 6 minute walk test (6MWT): continuous quantitative variable (meters). [Срок оценки: From the start of treatment until its completion at 12 weeks]
• 30-Second Sit-to-Stand Test [Срок оценки: From the start of treatment until its completion at 12 weeks]
• FEV1 (L and % predicted) [Срок оценки: From the start of treatment until its completion at 12 weeks.]
• FVC (L and % predicted) [Срок оценки: From the start of treatment until its completion at 12 weeks.]
• FEV1/FVC: [Срок оценки: From the start of treatment until its completion at 12 weeks.]

Вторичные конечные точки (12)

• maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) [Срок оценки: From the start of treatment until its completion at 12 weeks.]
• Peak Cough Flow (PCF) [Срок оценки: From the start of treatment until its completion at 12 weeks.]
• mMRC scale [Срок оценки: From the start of treatment until its completion at 12 weeks.]
• modified Borg scale [Срок оценки: From the start of treatment until its completion at 12 weeks.]
• Hand grip dynamometry [Срок оценки: From the start of treatment until its completion at 12 weeks.]
• Estimated maximum strength 1RM [Срок оценки: From the start of treatment until its completion at 12 weeks]
• Bruce's ramp test [Срок оценки: From the start of treatment until its completion at 12 weeks]
• Submaximal heart rate reached (80%, heart rate monitor) [Срок оценки: From the start of treatment until its completion at 12 weeks]
• FAACT-A/CS Questionnaire (anorexia-cachexia) [Срок оценки: From the start of treatment until its completion at 12 weeks]
• diet quality [Срок оценки: From the start of treatment until its completion at 12 weeks]
• International Physical Activity Questionnaire (IPAQ) [Срок оценки: From the start of treatment until its completion at 12 weeks]
• Godin questionnaire [Срок оценки: From the start of treatment until its completion at 12 weeks]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Histological or cytological diagnosis of lung cancer (resectable stage according to the multidisciplinary team).
• Patients scheduled for lung surgery with curative intent (lobectomy, segmentectomy, pneumonectomy, etc.).
• Ability to understand and sign informed consent.
• Clinical condition that allows participation in a supervised exercise program, according to medical evaluation, with an ECOG performance status of 0-2 (Eastern Cooperative Oncology Group Performance Status).
• Availability to perform the scheduled measurements and follow-ups (preoperative and postoperative).
• Ability to use the mobile application or have family support to do so. Exclusion 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

• Withdrawal of consent.
• Adverse events that contraindicate continued exercise (clinical decision).
• Failure to complete more than 30% of planned sessions (for per-protocol analysis; continue in ITT).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07478276 · PulmoSalud

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗