Lung CancerNCT07478276
PulmoSalud: Multimodal Program for Prehabilitation and Early Home Rehabilitation in Patients With Lung Cancer
A study testing Individualized pre-operative physical exercise, Post-operative rehabilitation physical exercise and Respiratory physiotherapy Prehabilitation in people with Lung Cancer, run by FranciscoVeraSerrano.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Individualized pre-operative physical exercise, Post-operative rehabilitation physical exercise and Respiratory physiotherapy Prehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jan 2028to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 20Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Individualized pre-operative physical exercise, Post-operative rehabilitation physical exercise, Respiratory physiotherapy Prehabilitation, Supporting mobile application (App), Home-based respiratory physiotherapy
- Keywords
- rehabilitation, prehabilitation, physical exercise, respiratory physiotherapy, multidisciplinary program, oncological treatment, adherence to treatment
- Medical subject headings
- Lung Neoplasms, Motor Activity, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized pre-operative physical exerciseOther
- Warm-up and mobility (8-10 minutes): Overall mobility of the spine, shoulder girdle, and hips; light walking or cycling; progressive muscle activation.
- Aerobic training (12-20 minutes): Options include walking, treadmill, or stationary cycling. Moderate intervals (light HIIT).
- 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).
- 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 exerciseOther
- 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.
- 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 PrehabilitationOther
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 physiotherapyOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test (6MWT): continuous quantitative variable (meters).
Measured: From the start of treatment until its completion at 12 weeks
30-Second Sit-to-Stand Test
Measured: From the start of treatment until its completion at 12 weeks
FEV1 (L and % predicted)
Measured: From the start of treatment until its completion at 12 weeks.
FVC (L and % predicted)
Measured: From the start of treatment until its completion at 12 weeks.
FEV1/FVC:
Measured: From the start of treatment until its completion at 12 weeks.
Secondary outcomes (13)
maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Measured: From the start of treatment until its completion at 12 weeks.
Peak Cough Flow (PCF)
Measured: From the start of treatment until its completion at 12 weeks.
mMRC scale
Measured: From the start of treatment until its completion at 12 weeks.
modified Borg scale
Measured: From the start of treatment until its completion at 12 weeks.
Hand grip dynamometry
Measured: From the start of treatment until its completion at 12 weeks.
Estimated maximum strength 1RM
Measured: From the start of treatment until its completion at 12 weeks
Bruce's ramp test
Measured: From the start of treatment until its completion at 12 weeks
Submaximal heart rate reached (80%, heart rate monitor)
Measured: From the start of treatment until its completion at 12 weeks
FAACT-A/CS Questionnaire (anorexia-cachexia)
Measured: From the start of treatment until its completion at 12 weeks
diet quality
Measured: From the start of treatment until its completion at 12 weeks
International Physical Activity Questionnaire (IPAQ)
Measured: From the start of treatment until its completion at 12 weeks
Godin questionnaire
Measured: From the start of treatment until its completion at 12 weeks
Subjective perception of effort (RPE, scale 0-10)
Measured: From the start of treatment until its completion at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startJan 2028 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FranciscoVeraSerrano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FranciscoVeraSerrano, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478276
- Sponsor's protocol ID
- PulmoSalud
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PulmoSalud: Multimodal Program for Prehabilitation and Early Home Rehabilitation in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT07478276
- Acronym / sponsor ID
- PulmoSalud
- Conditions
- Lung Cancer
- Keywords
- rehabilitation, prehabilitation, physical exercise, respiratory physiotherapy, multidisciplinary program, oncological treatment, adherence to treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- FranciscoVeraSerranoUniversity, hospital or other
- Study start
- Jan 2028 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | 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 physiotherapyPrehabilitation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized pre-operative physical exercise1. 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. | Other | intervention group |
| Post-operative rehabilitation physical exercise1. 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. | Other | intervention group |
| Respiratory physiotherapy PrehabilitationRe-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. | Other | intervention group |
| 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 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. | Device | intervention group |
| Home-based respiratory physiotherapyRe-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. | Other | intervention group |
Primary outcome
6 minute walk test (6MWT): continuous quantitative variable (meters).
Time frame: From the start of treatment until its completion at 12 weeks
30-Second Sit-to-Stand Test
Time frame: From the start of treatment until its completion at 12 weeks
FEV1 (L and % predicted)
Time frame: From the start of treatment until its completion at 12 weeks.
FVC (L and % predicted)
Time frame: From the start of treatment until its completion at 12 weeks.
FEV1/FVC:
Time frame: From the start of treatment until its completion at 12 weeks.
13 secondary outcomes
maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Time frame: From the start of treatment until its completion at 12 weeks.
Peak Cough Flow (PCF)
Time frame: From the start of treatment until its completion at 12 weeks.
mMRC scale
Time frame: From the start of treatment until its completion at 12 weeks.
modified Borg scale
Time frame: From the start of treatment until its completion at 12 weeks.
Hand grip dynamometry
Time frame: From the start of treatment until its completion at 12 weeks.
Estimated maximum strength 1RM
Time frame: From the start of treatment until its completion at 12 weeks
Bruce's ramp test
Time frame: From the start of treatment until its completion at 12 weeks
Submaximal heart rate reached (80%, heart rate monitor)
Time frame: From the start of treatment until its completion at 12 weeks
FAACT-A/CS Questionnaire (anorexia-cachexia)
Time frame: From the start of treatment until its completion at 12 weeks
diet quality
Time frame: From the start of treatment until its completion at 12 weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: From the start of treatment until its completion at 12 weeks
Godin questionnaire
Time frame: From the start of treatment until its completion at 12 weeks
Subjective perception of effort (RPE, scale 0-10)
Time frame: From the start of treatment until its completion at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized pre-operative physical exercise, Post-operative rehabilitation physical exercise and Respiratory physiotherapy Prehabilitation in people with Lung Cancer, run by FranciscoVeraSerrano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Jesús Viñolo Gil, Physiotherapy Doctor (609072670, mariajesus.vinolo@gm.uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.