Lung CancerNCT07499986
Respiratory Muscle Training in Patients Undergoing Lung Cancer Surgery
A study testing Inspiratory Muscle Training, Expiratory Muscle Training and Conventional Physiotherapy in people with Lung Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized, controlled, double-blind clinical trial aims to investigate the effectiveness of preoperative inspiratory muscle training (IMT) and expiratory muscle training (EMT) in patients scheduled for lung cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Inspiratory Muscle Training, Expiratory Muscle Training and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2026to 30 Dec 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of lung cancer staged IA to IIIB based on clinical staging
- Planned to undergo surgery via thoracotomy or videothoracoscopy (VATS)
- Having a smartphone and being capable of performing video call
Who cannot join
- Presence of a cardiac disease that affects quality of life (ASA II or better is required)
- Presence of severe cognitive problems or psychiatric disorders
- Presence of physical limitations (e.g., visual or hearing impairment, orthopedic problems)
- If the lung cancer diagnosis is not confirmed after frozen section or wedge resection, the patient will be removed from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cahidenur KOÇAK contact
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi
Istanbul, Üsküdar, 34668
About this study
This randomized, controlled, double-blind clinical trial aims to investigate the effectiveness of preoperative inspiratory muscle training (IMT) and expiratory muscle training (EMT) in patients scheduled for lung cancer surgery. Respiratory muscle dysfunction contributes to postoperative pulmonary complications (PPCs), prolonged hospitalization, and reduced functional recovery. Although IMT has been evaluated in several studies, the evidence is limited and heterogeneous, and the effectiveness of EMT in this population has never been studied.
This study will compare conventional preoperative physiotherapy alone with physiotherapy combined with IMT or EMT to determine their impact on postoperative clinical outcomes, respiratory muscle function, and exercise capacity.
Read the detailed description
Lung cancer surgery is frequently associated with postoperative pulmonary complications, which negatively impact recovery, hospital length of stay, and postoperative quality of life. Preoperative physiotherapy has been shown to improve clinical outcomes; however, the optimal content of such programs remains unclear.
Inspiratory muscle training has been associated with improvements in maximum inspiratory pressure (MIP), exercise capacity, and potentially reduced PPC rates, though findings are inconsistent. In contrast, no study has evaluated expiratory muscle training-despite its potential benefits in enhancing cough effectiveness, secretion clearance, and thoracic stability after surgery.
This trial is designed to fill this knowledge gap by systematically comparing IMT and EMT within a structured preoperative physiotherapy program. All groups will receive standard preoperative education, breathing exercises, and walking training. Participants randomized to the IMT or EMT groups will additionally undergo daily training using threshold-based devices at 40% of MIP or MEP, respectively, with intensity progression based on the Borg scale.
- Conditions
- Lung Cancer
- Being tested
- Inspiratory Muscle Training, Expiratory Muscle Training, Conventional Physiotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Also called IMT
Inspiratory muscle training is performed using a threshold device (PowerBreathe Classic) beginning at 40% of the individual's maximum inspiratory pressure (MIP). Training consists of 2 minutes of loading followed by 1 minute of rest, repeated for 7 cycles (total 21 minutes), performed twice daily, 5 days per week, until surgery. Load progression is adjusted to maintain a Borg dyspnea score of approximately 4/10. IMT is provided in addition to the full conventional physiotherapy program.
Expiratory Muscle TrainingOther
Also called EMT
Expiratory muscle training is performed using a threshold expiratory device (PowerBreathe Expir Medic) starting at 40% of the individual's maximum expiratory pressure (MEP). The protocol follows the same structure as IMT: 2 minutes loading / 1 minute rest for 7 cycles (21 minutes), twice daily, 5 days per week, until surgery, with load progression based on a Borg score of 4/10. EMT is provided in addition to the full conventional physiotherapy program.
Conventional PhysiotherapyOther
The conventional physiotherapy program includes diaphragmatic, basal, and thoracic breathing exercises, pursed-lip breathing, and walking training prescribed at 80% of the distance achieved during the six-minute walk test. Participants receive one in-person supervised session followed by two videoconference reinforcement sessions and then continue daily home exercises until the day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training + Conventional Physiotherapy | Experimental | Participants receive the full conventional physiotherapy program plus Inspiratory Muscle Training (IMT) using a threshold device set initially at 40% of the individual's maximum inspiratory pressure (MIP). Training consists of 2 minutes of loading followed by 1 minute of rest, repeated 7 times (total 21 minutes), performed twice daily, 5 days per week, until surgery. Receives: Other: Inspiratory Muscle Training; Other: Conventional Physiotherapy |
| Expiratory Muscle Training + Conventional Physiotherapy | Experimental | Participants receive the full conventional physiotherapy program plus Expiratory Muscle Training (EMT) using a threshold-based expiratory device set at 40% of maximum expiratory pressure (MEP). Training follows the same schedule as the IMT protocol (2 min loading / 1 min rest × 7 cycles), twice daily, 5 days per week, until surgery. Receives: Other: Expiratory Muscle Training; Other: Conventional Physiotherapy |
| Conventional Preoperative Physiotherapy (Control Group) | Experimental | Participants receive the standard preoperative physiotherapy program including diaphragmatic and thoracic breathing exercises, basal breathing techniques, and individualized walking training based on 80% of the 6-minute walk test distance. Three supervised sessions (one in-person, two via videoconference) are followed by daily home exercises until the surgery date. No respiratory muscle training device is used. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pulmonary Complications (PPCs)
Presence of postoperative pulmonary complications assessed using the Melbourne Group Scale (8 diagnostic criteria including fever, leukocytosis, radiological infiltrates, oxygen desaturation, increased secretions, abnormal lung auscultation, respiratory deterioration, and evidence of infection). A PPC is recorded if ≥4 criteria are met.
Measured: Average 2 weeks.
Secondary outcomes (8)
Length of Hospital Stay
Total number of days from the date of surgery to hospital discharge.
Measured: Average 2 weeks.
Maximum Inspiratory Pressure (MIP)
Maximum inspiratory pressure measured using a standardized mouth pressure device (Cosmed Pony Fx) according to ATS/ERS respiratory muscle testing guidelines.
Measured: Baseline and preoperative reassessment.
Maximum Expiratory Pressure (MEP)
Maximum expiratory pressure measured using a standardized mouth pressure device (Cosmed Pony Fx) according to ATS/ERS respiratory muscle testing guidelines.
Measured: Baseline and preoperative reassessment.
Six-Minute Walk Distance (6MWD)
Distance covered during the standardized six-minute walk test performed according to ATS guidelines.
Measured: Baseline and preoperative reassessment.
Forced Expiratory Volume in 1 Second (FEV₁)
FEV₁ measured by spirometry (Cosmed Pony Fx) following ATS/ERS pulmonary function testing standards.
Measured: Baseline and preoperative reassessment.
Forced Vital Capacity (FVC)
FVC measured by spirometry (Cosmed Pony Fx) following ATS/ERS pulmonary function testing standards.
Measured: Baseline and preoperative reassessment.
Anxiety and Depression Evaluation
Anxiety and depression levels measured using the Hospital Anxiety and Depression Scale.The Hospital Anxiety and Depression Scale (HADS) includes two subscales-anxiety (HADS-A) and depression (HADS-D)-each scored from 0 to 21. Higher scores indicate greater symptom severity. Scores of 0-7 are considered within the normal range, 8-10 indicate borderline or possible anxiety/depression, and scores of 11 or above reflect clinically significant symptoms.
Measured: Baseline and preoperative reassessment.
Postoperative Surgical Complications
Surgical complications classified according to the Clavien-Dindo classification (Grades I-V).
Measured: Average 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a three-arm, parallel-group, randomized controlled design to compare the effects of conventional preoperative physiotherapy alone with physiotherapy combined with inspiratory muscle training (IMT) or expiratory muscle training (EMT). Participants are randomized in equal allocation (1:1:1) using a block randomization sequence with concealed allocation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA PEHLIVAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499986
- Sponsor's protocol ID
- RMT_Preop 1
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Training in Patients Undergoing Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT07499986
- Acronym / sponsor ID
- RMT_Preop 1
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 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.
This randomized, controlled, double-blind clinical trial aims to investigate the effectiveness of preoperative inspiratory muscle training (IMT) and expiratory muscle training (EMT) in patients scheduled for lung cancer surgery. Respiratory muscle dysfunction contributes to postoperative pulmonary complications (PPCs), prolonged hospitalization, and reduced functional recovery. Although IMT has been evaluated in several studies, the evidence is limited and heterogeneous, and the effectiveness of EMT in this population has never been studied.
This study will compare conventional preoperative physiotherapy alone with physiotherapy combined with IMT or EMT to determine their impact on postoperative clinical outcomes, respiratory muscle function, and exercise capacity.
Detailed description
Lung cancer surgery is frequently associated with postoperative pulmonary complications, which negatively impact recovery, hospital length of stay, and postoperative quality of life. Preoperative physiotherapy has been shown to improve clinical outcomes; however, the optimal content of such programs remains unclear.
Inspiratory muscle training has been associated with improvements in maximum inspiratory pressure (MIP), exercise capacity, and potentially reduced PPC rates, though findings are inconsistent. In contrast, no study has evaluated expiratory muscle training-despite its potential benefits in enhancing cough effectiveness, secretion clearance, and thoracic stability after surgery.
This trial is designed to fill this knowledge gap by systematically comparing IMT and EMT within a structured preoperative physiotherapy program. All groups will receive standard preoperative education, breathing exercises, and walking training. Participants randomized to the IMT or EMT groups will additionally undergo daily training using threshold-based devices at 40% of MIP or MEP, respectively, with intensity progression based on the Borg scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a three-arm, parallel-group, randomized controlled design to compare the effects of conventional preoperative physiotherapy alone with physiotherapy combined with inspiratory muscle training (IMT) or expiratory muscle training (EMT). Participants are randomized in equal allocation (1:1:1) using a block randomization sequence with concealed allocation.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training + Conventional Physiotherapy | Experimental | Other: Inspiratory Muscle Training, Other: Conventional PhysiotherapyParticipants receive the full conventional physiotherapy program plus Inspiratory Muscle Training (IMT) using a threshold device set initially at 40% of the individual's maximum inspiratory pressure (MIP). Training consists of 2 minutes of loading followed by 1 minute of rest, repeated 7 times (total 21 minutes), performed twice daily, 5 days per week, until surgery. |
| Expiratory Muscle Training + Conventional Physiotherapy | Experimental | Other: Expiratory Muscle Training, Other: Conventional PhysiotherapyParticipants receive the full conventional physiotherapy program plus Expiratory Muscle Training (EMT) using a threshold-based expiratory device set at 40% of maximum expiratory pressure (MEP). Training follows the same schedule as the IMT protocol (2 min loading / 1 min rest × 7 cycles), twice daily, 5 days per week, until surgery. |
| Conventional Preoperative Physiotherapy (Control Group) | Experimental | Other: Conventional PhysiotherapyParticipants receive the standard preoperative physiotherapy program including diaphragmatic and thoracic breathing exercises, basal breathing techniques, and individualized walking training based on 80% of the 6-minute walk test distance. Three supervised sessions (one in-person, two via videoconference) are followed by daily home exercises until the surgery date. No respiratory muscle training device is used. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of lung cancer staged IA to IIIB based on clinical staging
- Planned to undergo surgery via thoracotomy or videothoracoscopy (VATS)
- Having a smartphone and being capable of performing video call
Key exclusion criteria (4 listed)
- Presence of a cardiac disease that affects quality of life (ASA II or better is required)
- Presence of severe cognitive problems or psychiatric disorders
- Presence of physical limitations (e.g., visual or hearing impairment, orthopedic problems)
- If the lung cancer diagnosis is not confirmed after frozen section or wedge resection, the patient will be removed from the study
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 |
|---|---|---|
| Inspiratory Muscle TrainingAlso: IMTInspiratory muscle training is performed using a threshold device (PowerBreathe Classic) beginning at 40% of the individual's maximum inspiratory pressure (MIP). Training consists of 2 minutes of loading followed by 1 minute of rest, repeated for 7 cycles (total 21 minutes), performed twice daily, 5 days per week, until surgery. Load progression is adjusted to maintain a Borg dyspnea score of approximately 4/10. IMT is provided in addition to the full conventional physiotherapy program. | Other | Inspiratory Muscle Training + Conventional Physiotherapy |
| Expiratory Muscle TrainingAlso: EMTExpiratory muscle training is performed using a threshold expiratory device (PowerBreathe Expir Medic) starting at 40% of the individual's maximum expiratory pressure (MEP). The protocol follows the same structure as IMT: 2 minutes loading / 1 minute rest for 7 cycles (21 minutes), twice daily, 5 days per week, until surgery, with load progression based on a Borg score of 4/10. EMT is provided in addition to the full conventional physiotherapy program. | Other | Expiratory Muscle Training + Conventional Physiotherapy |
| Conventional PhysiotherapyThe conventional physiotherapy program includes diaphragmatic, basal, and thoracic breathing exercises, pursed-lip breathing, and walking training prescribed at 80% of the distance achieved during the six-minute walk test. Participants receive one in-person supervised session followed by two videoconference reinforcement sessions and then continue daily home exercises until the day of surgery. | Other | Conventional Preoperative Physiotherapy (Control Group), Expiratory Muscle Training + Conventional Physiotherapy, Inspiratory Muscle Training + Conventional Physiotherapy |
Primary outcome
Postoperative Pulmonary Complications (PPCs)
Time frame: Average 2 weeks.
Presence of postoperative pulmonary complications assessed using the Melbourne Group Scale (8 diagnostic criteria including fever, leukocytosis, radiological infiltrates, oxygen desaturation, increased secretions, abnormal lung auscultation, respiratory deterioration, and evidence of infection). A PPC is recorded if ≥4 criteria are met.
8 secondary outcomes
Length of Hospital Stay
Time frame: Average 2 weeks.
Maximum Inspiratory Pressure (MIP)
Time frame: Baseline and preoperative reassessment.
Maximum Expiratory Pressure (MEP)
Time frame: Baseline and preoperative reassessment.
Six-Minute Walk Distance (6MWD)
Time frame: Baseline and preoperative reassessment.
Forced Expiratory Volume in 1 Second (FEV₁)
Time frame: Baseline and preoperative reassessment.
Forced Vital Capacity (FVC)
Time frame: Baseline and preoperative reassessment.
Anxiety and Depression Evaluation
Time frame: Baseline and preoperative reassessment.
Postoperative Surgical Complications
Time frame: Average 2 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 30 Mar 2026.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Cahidenur KOÇAK contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training, Expiratory Muscle Training and Conventional Physiotherapy in people with Lung Cancer, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 ESRA PEHLİVAN (+90 777 87 77, fztesrakambur@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pulmonary Complications (PPCs) (time frame: Average 2 weeks.). 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 30 Mar 2026.