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

Sponsor
FranciscoVeraSerrano
Study ID
NCT07478276
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Individualized pre-operative physical exercise — OTHER
    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: assisted squats or sit-to-stand exercises; low and high banded rows; chest presses with bands or light dumbbells; hip raises; lateral marches with bands; scapular work (retraction, Y-T-W). 4. Cool-down (5-8 minutes): Thoracic and scapular mobility exercises; controlled breathing (coordinated with respiratory physiotherapy). Independent home session (1 time/week): Performed with the support of the PulmoSalud application.
  • Post-operative rehabilitation physical exercise — OTHER
    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.
  • 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.

Study Details

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.

Key Dates

First listed
Mar 17, 2026
Start date
Jan 31, 2028
Status verified
Mar 2026
Primary completion
Oct 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: intervention group
    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.
  • No Intervention: Control Group
    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.

Primary Outcome Measure

6 minute walk test (6MWT): continuous quantitative variable (meters). [ Time Frame: From the start of treatment until its completion at 12 weeks ]

Central Contacts

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