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

NCT07478276 | Not Yet Recruiting

• 1 other identifier: PulmoSalud
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lung Cancer

Keywords

rehabilitation; prehabilitation; physical exercise; respiratory physiotherapy; multidisciplinary program; oncological treatment; adherence to treatment

Outcome Measures

Primary Outcomes (5)

• 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.

Secondary Outcomes (13)

• 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.

• 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.

Study Arms (2)

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.

Other: Individualized pre-operative physical exercise; Other: Post-operative rehabilitation physical exercise; Other: Respiratory physiotherapy Prehabilitation; Device: Supporting mobile application (App); Other: Home-based respiratory physiotherapy

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.

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.

intervention group

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.

intervention group

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.

intervention group

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.

intervention group

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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.
• \. 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).
• \. Distant metastases or metastatic cancer that contraindicate surgery with curative intent.
• \. Planned palliative surgery or life expectancy \< 3 months.
• \. Home oxygen therapy with severe, uncorrectable hypoxemia, as determined by clinical judgment.
• \. 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.
• \. Pregnancy.
• \. Participation in another interventional clinical trial that may interfere with the study objectives or its primary outcome.
• \. 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).

Sponsors & Collaborators

• FranciscoVeraSerrano: lead

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior; Health Behavior

Central Study Contacts

María Jesús Viñolo Gil, Physiotherapy Doctor

CONTACT

609072670; mariajesus.vinolo@gm.uca.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate in Physiotherapy

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 17, 2026
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share