Video Assisted Thoracic Surgery (VATS)NCT06813144
Effectiveness of Respiratory Muscle Training with a Mobile Application After Lobectomy
A study testing inspiratory muscle exercise in people with Video Assisted Thoracic Surgery (VATS) and Thoracic Surgery, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Video Assisted Thoracic Surgery (VATS), Thoracic Surgery, Respiratory Muscle
- What is being tested?
- inspiratory muscle exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Feb 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study,
- Being clinically stable,
- Being a lung cancer patient with a planned lobectomy with VATS,
- Being between the ages of 18-65,
- Being able to cooperate with the tests to be performed.
Who cannot join
- Having any orthopedic or neurological problem that prevents walking,
- Having undergone any surgery related to the thoracic wall,
- Having diseases that will affect respiratory parameters such as severe heart failure, severe chronic obstructive pulmonary disease (COPD).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effectiveness of Respiratory Muscle Training with a Mobile Application in the Early Postoperative Period After Lobectomy
It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback.
Read the detailed description
It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). Additionally, there is currently no study assessing the effectiveness of IMT using a smart adapter in patients who have undergone lobectomy. It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback. The aim of this study is to examine the changes in respiratory muscle strength and exercise capacity in patients after lobectomy via VATS, comparing classical IMT, mobile application-supported IMT, and a control group that does not receive IMT.
- Conditions
- Video Assisted Thoracic Surgery (VATS), Thoracic Surgery, Respiratory Muscle, Lung Cancer (NSCLC)
- Being tested
- inspiratory muscle exercise
- Keywords
- lung cancer, vats, inspiratory muscle training
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle exerciseOther
Inspiratory muscle training will be given with or without smart adaptor.
| Study group | Role | What they receive |
|---|---|---|
| Classic IMT | Active comparator | Individuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery.
The group will receive standard postoperative physiotherapy and rehabilitation as well as classical inspiratory muscle strength training with the noninvasive Powerbreath Medic Plus device (POWERbreathe International Ltd., Warwickshire, England). Training will start with 40 percent of the initial MIP level and progress will be planned according to Modified Borg between 3-4. It will be repeated twice a day for 3 times 10 minutes. Training will start on the 1st postoperative day after the participants are transferred to the ward and they will be asked to continue at home. The progress plan will be adjusted by talking to the patient on the phone every 2 days after discharge. Receives: Other: inspiratory muscle exercise |
| IMT with mobile application | Experimental | Individuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery.
The group will receive standard postoperative physiotherapy and rehabilitation as well as inspiratory muscle training with the smart adapter support (POWERbreathe International Ltd., Warwickshire, England). Training will start with 40 percent of the initial MIP level and progress will be planned according to Modified Borg between 3-4. It will be repeated twice a day for 3 times 10 minutes. Training will start on the 1st postoperative day after the participants are transferred to the ward and they will be asked to continue at home. The progress plan will be adjusted by talking to the patient on the phone every 2 days after discharge. Receives: Other: inspiratory muscle exercise |
| control group | No intervention | Individuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery. This group will receive only standard physiotherapy and rehabilitation: respiratory exercises (thoracic expansion exercises, diaphragmatic breathing, incentive spirometry), mobilization and cough/huffing training. Participants will be advised to continue these exercises regularly at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values.
Measured: Measurements will be performed before surgery (the day before surgery), at discharge and during the follow-up period after surgery (10-15 days after discharge).
Expiratory muscle strength
Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values.
Measured: Measurements will be performed before surgery (the day before surgery), at discharge and during the follow-up period after surgery (10-15 days after discharge).
Secondary outcomes (6)
Functional exercise capacity
6-minute walk test (6MWT) will be used to evaluate functional exercise capacity.
Measured: Evaluations will be made before surgery (the day before surgery) and during the follow-up period (10-15 days after discharge).
Postoperative Pulmonary Complications
Postoperative pulmonary complications will be evaulate by Melbourne Group Scale. If more than 4 parameters are positive, it will be considered as having postoperative pulmonary complication.
Measured: Postoperative first-fifth days.
Exercise Motivation
Exercise Motivation Attitude Scale will be used. This scale consists of 3 sub-dimensions (negative attitude and thought/positive view and health/physical appearance and health).
Measured: The evaluation will be made during the control period (10-15 days after discharge).
Dyspnea Level
Modified Borg Scale will be used to evaluate dyspnea.
Measured: An evaluation will be made in the preoperative (the day before surgery) and control period (10-15 days after discharge).
Quality of Life
SF-12 Quality of Life Scale will be used to assess quality of life.
Measured: The evaluation will be made during the preoerative (the day before surgery) and control (10-15 days after discharge) period.
Physical Performance
The Short Physical Performance Battery, a frequently used test in cardiovascular and pulmonary diseases, will be used.
Measured: Evaluations will be made in the preoperative (the day before surgery) and control (10-15 days after discharge) periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Assisted Thoracic Surgery (VATS)Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Sirakaya, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, Professorr, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813144
- Sponsor's protocol ID
- E-30603717-050.04-2400055696
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Respiratory Muscle Training with a Mobile Application in the Early Postoperative Period After Lobectomy
- ClinicalTrials.gov ID
- NCT06813144
- Acronym / sponsor ID
- E-30603717-050.04-2400055696
- Conditions
- Video Assisted Thoracic Surgery (VATS), Thoracic Surgery, Respiratory Muscle, Lung Cancer (NSCLC)
- Keywords
- lung cancer, vats, inspiratory muscle training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback.
Detailed description
It has been observed that there are negative effects on respiratory muscle strength following lobectomy. This has led to the necessity of respiratory muscle training to mitigate these adverse effects. Most studies conducted so far focus on the late postoperative period, and there are only a few studies evaluating the effectiveness of early postoperative inspiratory muscle training (IMT). Additionally, there is currently no study assessing the effectiveness of IMT using a smart adapter in patients who have undergone lobectomy. It is believed that this method could be useful for facilitating patient follow-up and increasing patient motivation through visual feedback. The aim of this study is to examine the changes in respiratory muscle strength and exercise capacity in patients after lobectomy via VATS, comparing classical IMT, mobile application-supported IMT, and a control group that does not receive IMT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classic IMT | Active comparator | Other: inspiratory muscle exerciseIndividuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery. The group will receive standard postoperative physiotherapy and rehabilitation as well as classical inspiratory muscle strength training with the noninvasive Powerbreath Medic Plus device (POWERbreathe International Ltd., Warwickshire, England). Training will start with 40 percent of the initial MIP level and progress will be planned according to Modified Borg between 3-4. It will be repeated twice a day for 3 times 10 minutes. Training will start on the 1st postoperative day after the participants are transferred to the ward and they will be asked to continue at home. The progress plan will be adjusted by talking to the patient on the phone every 2 days after discharge. |
| IMT with mobile application | Experimental | Other: inspiratory muscle exerciseIndividuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery. The group will receive standard postoperative physiotherapy and rehabilitation as well as inspiratory muscle training with the smart adapter support (POWERbreathe International Ltd., Warwickshire, England). Training will start with 40 percent of the initial MIP level and progress will be planned according to Modified Borg between 3-4. It will be repeated twice a day for 3 times 10 minutes. Training will start on the 1st postoperative day after the participants are transferred to the ward and they will be asked to continue at home. The progress plan will be adjusted by talking to the patient on the phone every 2 days after discharge. |
| control group | No intervention | –Individuals who are between the ages of 18-65 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery. This group will receive only standard physiotherapy and rehabilitation: respiratory exercises (thoracic expansion exercises, diaphragmatic breathing, incentive spirometry), mobilization and cough/huffing training. Participants will be advised to continue these exercises regularly at home. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the study,
- Being clinically stable,
- Being a lung cancer patient with a planned lobectomy with VATS,
- Being between the ages of 18-65,
- Being able to cooperate with the tests to be performed.
Key exclusion criteria (3 listed)
- Having any orthopedic or neurological problem that prevents walking,
- Having undergone any surgery related to the thoracic wall,
- Having diseases that will affect respiratory parameters such as severe heart failure, severe chronic obstructive pulmonary disease (COPD).
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 exerciseInspiratory muscle training will be given with or without smart adaptor. | Other | Classic IMT, IMT with mobile application |
Primary outcome
Inspiratory muscle strength
Time frame: Measurements will be performed before surgery (the day before surgery), at discharge and during the follow-up period after surgery (10-15 days after discharge).
Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values.
Expiratory muscle strength
Time frame: Measurements will be performed before surgery (the day before surgery), at discharge and during the follow-up period after surgery (10-15 days after discharge).
Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values.
6 secondary outcomes
Functional exercise capacity
Time frame: Evaluations will be made before surgery (the day before surgery) and during the follow-up period (10-15 days after discharge).
Postoperative Pulmonary Complications
Time frame: Postoperative first-fifth days.
Exercise Motivation
Time frame: The evaluation will be made during the control period (10-15 days after discharge).
Dyspnea Level
Time frame: An evaluation will be made in the preoperative (the day before surgery) and control period (10-15 days after discharge).
Quality of Life
Time frame: The evaluation will be made during the preoerative (the day before surgery) and control (10-15 days after discharge) period.
Physical Performance
Time frame: Evaluations will be made in the preoperative (the day before surgery) and control (10-15 days after discharge) periods.
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 6 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ebru Calik Kutukcu, Professorr study director
Hacettepe University
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 exercise in people with Video Assisted Thoracic Surgery (VATS) and Thoracic Surgery, run by Hacettepe University 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 5 inclusion and 3 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 6 Feb 2025. 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 Funda Alma, MsC (+905079394348, fundasirakaya@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: Measurements will be performed before surgery (the day before surgery), at discharge and during the follow-up period after surgery (10-15 days after discharge).). The study lists 2 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 6 Feb 2025.