Pulmonary NoduleNCT04805723
Effects of Surgery Types in Patients With Pulmonary Nodules
A study testing VATS and Thoracotomy in people with Pulmonary Nodule, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the pre-post operative effects of video-assisted thoracoscopy surgery (VATS) and thoracotomy on pulmonary function, exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule
- What is being tested?
- VATS and Thoracotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 18-80 years of age,
- Patients with pulmonary nodule who were planned lobectomy surgery with one of VATS or thoracotomy techniques,
- Being able to walk,
Who cannot join
- Any type of surgery planned except lobectomy,
- Having heart failure or atrial fibrillation,
- Having acute viral infections during all assessment,
- History of acute myocard infarction within last six months,
- Uncontrolled diabetes or hypertension,
- Having orthopedic, neurological and psychological disorders that influence the results of study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara
About this study
Official title: Comparison of Video-Assisted Thoracoscopy Surgery and Thoracotomy on Cardiorespiratory Parameters in Patients With Pulmonary Nodules
The investigators aimed to compare the pre-post operative effects of video-assisted thoracoscopy surgery (VATS) and thoracotomy on pulmonary function, exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain in patients with pulmonary nodules.
Read the detailed description
According to global cancer statistics, lung cancer accounts for 11.6% of all cancer cases and it is the most common type of cancer in the world. Surgery is the primary treatment approach, especially in early stages lung cancer. Cardiopulmonary fitness of patients with lung cancer is lower than healthy individuals due to the disease itself and treatments. Pulmonary function, exercise capacity and physical activity level are affected in lung cancer depending on the resected lung tissue and the type of surgery. VATS and thoracotomy surgeries, which are the most preferred techniques in lung cancer, have advantages and disadvantages over each other. There are few studies compared the early effects of two surgeries on the pulmonary function, exercise capacity, physical activity, quality of life and fatigue. And also, no study compared the effects of two surgeries on respiratory muscle endurance and peripheral muscle strength, previously.
According to sample size calculation, at least 15 patients with pulmonary lesion both VATS and thoracotomy groups would be included in the study. The demographic, physical and physiological characteristics were recorded from the patient files. Pulmonary function, functional exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain were evaluated pre and two weeks after postoperative term. Primary outcomes were pulmonary function, functional exercise capacity and physical activity level. Secondary outcomes were respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain.
- Conditions
- Pulmonary Nodule
- Being tested
- VATS, Thoracotomy
- Keywords
- pulmonary nodule, pulmonary function, functional exercise capacity, physical activity, respiratory muscle strength, respiratory muscle endurance, quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATSProcedure or surgery
Video-assisted thoracoscopic surgery is a minimal invasive technique in which used to diagnose or treat for lung diseases. During this surgery, one or two small incisions are opened via camera and surgical instruments in patient's chest wall. Thus, less muscle and nerve tissue are damaged.
Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung.
ThoracotomyProcedure or surgery
Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary nodule scheduled VATS | Experimental | Patients with pulmonary nodule scheduled VATS were included in this study. Inclusion and exclusion criteria were considered.
Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery. Receives: Procedure: VATS |
| Patients with pulmonary nodule scheduled thoracotomy | Experimental | Patients with pulmonary nodule scheduled thoracotomy were included in this study. Inclusion and exclusion criteria were considered.
Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery. Receives: Procedure: Thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test (Forced expiratory volume in one second)
Forced expiratory volume in one second was evaluated with spirometry according American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The value was represented as percentages.
Measured: first day
Pulmonary function test (Forced vital capacity)
Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Measured: first day
Pulmonary function test (Forced expiratory volume in one second/Forced vital capacity)
Forced expiratory volume in one second/Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Measured: first day
Pulmonary function test (Peak expiratory flow)
Peak expiratory flow was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Measured: first day
Pulmonary function test (Flow rate 25-75% of forced expiratory volume)
Flow rate 25-75% of forced expiratory volume was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Measured: first day
6-minute walk test
6-minute walk test were used to assess functional exercise capacity according to the guidelines. The test was repeated twice in the same day with 30 min interval. The highest distance was recorded for analysis.
Measured: first day
6-minute stepper test
6-minute stepper test were used to assess functional exercise capacity according to the guidelines. The height of the stepper used for test was 20 cm. A cycle of up and down was define as one step. The number of steps was recorded for analysis.
Measured: second day
Physical activity assessment
Total energy expenditure (joules/day), active energy expenditure (>3.0 metabolic equivalents (METs)) (joules/day), physical activity duration (>3.0 METs) (min/day), average MET (METs/day), number of steps (steps/day), lying down (min/day) and sleeping duration (min/day) were measured to interpret the physical activity level of the patients via metabolic holter device. The metabolic holter was worn over triceps brachii muscle of non-dominant extremity for two consecutive days. The patients' activity level were categorized according to number of steps and average MET sums.
Measured: second day
Secondary outcomes (9)
Inspiratory muscle strength test
Maximal inspiratory pressure (MIP) was performed to evaluate respiratory muscle strength. Evaluation was done by using portable mouth pressure device accordance with the guidelines. The MIP was measured at residual volume after maximal expiration. The measurements were repeated at least seven times for technically acceptable value.
Measured: first day
Expiratory muscle strength test
Maximal expiratory pressure (MEP) was performed to evaluate respiratory muscle strength. Evaluation was done by using portable mouth pressure device accordance with the guidelines. The MEP was measured from total lung capacity after maximal inspiration. The measurements were repeated at least seven times for technically acceptable value.
Measured: first day
Peripheral muscle strength test
Shoulder abduction, shoulder flexion, elbow extension, quadriceps femoris muscle strength and hand grip strength were evaluated using a hand held dynamometer. The measurements of each muscle were repeated bilaterally three times.
Measured: first day
Inspiratory muscle endurance test
Inspiratory muscle endurance test were performed using respiratory muscle trainer (POWERbreathe) according to incremental threshold loading test protocol. The endurance test was started at thirty percentage of MIP and each two minutes the load of test was increased by ten percentage of MIP. The highest percentage of MIP could be reached and sustained for at least 1 min was defined as maximal load and time were recorded for analysis.
Measured: second day
Modified borg scale
This scale was used to evaluate dyspnea and fatigue perception during 6-minute walk test and 6-minute stepper test. It was scored between 0 and 10. The lowest value was 0 which was meant no dyspnea or fatigue and the highest value was 10 which was meant worse and severe dyspnea and fatigue.
Measured: first and second day
Quality of life scale
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0 (Turkish version of scale) were used. The questionnaire comprise of 30 items in which five scales and several single items are graded from 1 (not at all) to 4 (very much) except for 29-30 items. All scales and items' scores are expressed by transforming to a 0-100 scale. Higher values except symptom scale represent higher quality of life. The minimum value was '0' and the maximum value was '100'. The highest value was meant better quality of life. The highest value for symptom scale was meant worse symptom.
Measured: first day
Fatigue
Fatigue severity scale (Turkish version of scale) were applied. This one-dimensional scale compose of nine items scored between 1 (completely disagree) and 7 (completely agree). The minimum total value was 7 and the maximum total value was 63. The cut-off value for severe fatigue was 36 and the highest total value is meant severe fatigue.
Measured: second day
Dyspnea perception
The Modified Medical Research Council dyspnea scale were performed to determine dyspnea perception during daily living activities. This categorical scale consisting of five expressions are scored from '0' to '4'. The minimum value was 0 which means no complain about dyspnea apart from strenuous exercise; the maximum value was 4 which means too breathless for leaving the house or dyspnea while getting dressed. The highest value was refered to severe shortness of breath during activities of daily living.
Measured: first day
Pain severity
To evaluate pain severity, visual analog scale were used. The minimum value was 0 mm (no pain) and the maximum value was 100 mm (worst pain). The highest score was 100 mm which was meant worse pain severity.
Measured: second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start10 Jul 2018
- Primary completion25 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulmonary NoduleStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Ece BAYTOK, MsC., Study chair, Gazi UniversityZeliha ÇELİK, MsC., Principal investigator, Gazi UniversityMerve ŞATIR TÜRK, MD., Principal investigator, Gazi UniversityAli ÇELİK, Assoc. Prof., Principal investigator, Gazi Universityİsmail Cüneyt KURUL, Prof. Dr., Principal investigator, Gazi UniversityMeral Boşnak GÜÇLÜ, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805723
- Sponsor's protocol ID
- Gazi University 509
- Status last verified
- Mar 2021
- First submitted
- 28 Feb 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Impairments after curative intent treatment for non-small cell lung cancer: a comparison with age and gender-matched healthy controls. Respir Med. 2015 Oct;109(10):1332-9. doi: 10.1016/j.rmed.2015.08.015. Epub 2015 Aug 29.
PubMed 26342839Nagamatsu Y, Maeshiro K, Kimura NY, Nishi T, Shima I, Yamana H, Shirouzu K. Long-term recovery of exercise capacity and pulmonary function after lobectomy. J Thorac Cardiovasc Surg. 2007 Nov;134(5):1273-8. doi: 10.1016/j.jtcvs.2007.06.025.
PubMed 17976462Kaseda S, Aoki T, Hangai N, Shimizu K. Better pulmonary function and prognosis with video-assisted thoracic surgery than with thoracotomy. Ann Thorac Surg. 2000 Nov;70(5):1644-6. doi: 10.1016/s0003-4975(00)01909-3.
PubMed 11093502Cheng X, Onaitis MW, D'amico TA, Chen H. Minimally Invasive Thoracic Surgery 3.0: Lessons Learned From the History of Lung Cancer Surgery. Ann Surg. 2018 Jan;267(1):37-38. doi: 10.1097/SLA.0000000000002405. No abstract available.
PubMed 28692471Upham TC, Onaitis MW. Video-assisted thoracoscopic surgery versus robot-assisted thoracoscopic surgery versus thoracotomy for early-stage lung cancer. J Thorac Cardiovasc Surg. 2018 Jul;156(1):365-368. doi: 10.1016/j.jtcvs.2018.02.064. Epub 2018 Mar 2. No abstract available.
PubMed 29921098Park TY, Park YS. Long-term respiratory function recovery in patients with stage I lung cancer receiving video-assisted thoracic surgery versus thoracotomy. J Thorac Dis. 2016 Jan;8(1):161-8. doi: 10.3978/j.issn.2072-1439.2016.01.14.
PubMed 26904225Granger CL, Parry SM, Edbrooke L, Denehy L. Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management. Physiotherapy. 2016 Sep;102(3):256-63. doi: 10.1016/j.physio.2015.10.007. Epub 2015 Oct 23.
PubMed 26597694Schwartz RM, Yip R, Flores RM, Olkin I, Taioli E, Henschke C; I-ELCAP Investigators. The impact of resection method and patient factors on quality of life among stage IA non-small cell lung cancer surgical patients. J Surg Oncol. 2017 Feb;115(2):173-180. doi: 10.1002/jso.24478. Epub 2016 Oct 28.
PubMed 27790715Nomori H, Kobayashi R, Fuyuno G, Morinaga S, Yashima H. Preoperative respiratory muscle training. Assessment in thoracic surgery patients with special reference to postoperative pulmonary complications. Chest. 1994 Jun;105(6):1782-8. doi: 10.1378/chest.105.6.1782.
PubMed 8205877
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video-Assisted Thoracoscopy Surgery and Thoracotomy on Cardiorespiratory Parameters in Patients With Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT04805723
- Acronym / sponsor ID
- Gazi University 509
- Conditions
- Pulmonary Nodule
- Keywords
- pulmonary nodule, pulmonary function, functional exercise capacity, physical activity, respiratory muscle strength, respiratory muscle endurance, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 18 Mar 2021 (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.
The investigators aimed to compare the pre-post operative effects of video-assisted thoracoscopy surgery (VATS) and thoracotomy on pulmonary function, exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain in patients with pulmonary nodules.
Detailed description
According to global cancer statistics, lung cancer accounts for 11.6% of all cancer cases and it is the most common type of cancer in the world. Surgery is the primary treatment approach, especially in early stages lung cancer. Cardiopulmonary fitness of patients with lung cancer is lower than healthy individuals due to the disease itself and treatments. Pulmonary function, exercise capacity and physical activity level are affected in lung cancer depending on the resected lung tissue and the type of surgery. VATS and thoracotomy surgeries, which are the most preferred techniques in lung cancer, have advantages and disadvantages over each other. There are few studies compared the early effects of two surgeries on the pulmonary function, exercise capacity, physical activity, quality of life and fatigue. And also, no study compared the effects of two surgeries on respiratory muscle endurance and peripheral muscle strength, previously.
According to sample size calculation, at least 15 patients with pulmonary lesion both VATS and thoracotomy groups would be included in the study. The demographic, physical and physiological characteristics were recorded from the patient files. Pulmonary function, functional exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain were evaluated pre and two weeks after postoperative term. Primary outcomes were pulmonary function, functional exercise capacity and physical activity level. Secondary outcomes were respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary nodule scheduled VATS | Experimental | Procedure: VATSPatients with pulmonary nodule scheduled VATS were included in this study. Inclusion and exclusion criteria were considered. Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery. |
| Patients with pulmonary nodule scheduled thoracotomy | Experimental | Procedure: ThoracotomyPatients with pulmonary nodule scheduled thoracotomy were included in this study. Inclusion and exclusion criteria were considered. Pulmonary function (spirometry), functional exercise capacity (6-minute walk test (6-MWT); 6-minute stepper test (6-MST)), physical activity level (metabolic holter), respiratory (maximal inspiratory and expiratory pressures (MIP-MEP); mouth pressure device) and peripheral muscle strength (dynamometer), inspiratory muscle endurance (incremental loading test), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)), fatigue (Fatigue Severity Scale), dyspnea perception (Modified Medical Research Council dyspnea scale (MMRC)) and pain severity (Visual Analog Scale) were assessed before VATS and average two weeks after surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between 18-80 years of age,
- Patients with pulmonary nodule who were planned lobectomy surgery with one of VATS or thoracotomy techniques,
- Being able to walk,
Key exclusion criteria (6 listed)
- Any type of surgery planned except lobectomy,
- Having heart failure or atrial fibrillation,
- Having acute viral infections during all assessment,
- History of acute myocard infarction within last six months,
- Uncontrolled diabetes or hypertension,
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 |
|---|---|---|
| VATSVideo-assisted thoracoscopic surgery is a minimal invasive technique in which used to diagnose or treat for lung diseases. During this surgery, one or two small incisions are opened via camera and surgical instruments in patient's chest wall. Thus, less muscle and nerve tissue are damaged. Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung. | Procedure or surgery | Patients with pulmonary nodule scheduled VATS |
| ThoracotomyThoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung. | Procedure or surgery | Patients with pulmonary nodule scheduled thoracotomy |
Primary outcome
Pulmonary function test (Forced expiratory volume in one second)
Time frame: first day
Forced expiratory volume in one second was evaluated with spirometry according American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The value was represented as percentages.
Pulmonary function test (Forced vital capacity)
Time frame: first day
Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Forced expiratory volume in one second/Forced vital capacity)
Time frame: first day
Forced expiratory volume in one second/Forced vital capacity was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Peak expiratory flow)
Time frame: first day
Peak expiratory flow was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
Pulmonary function test (Flow rate 25-75% of forced expiratory volume)
Time frame: first day
Flow rate 25-75% of forced expiratory volume was evaluated with spirometry according to ATS and ERS criteria. The value was represented as percentages.
6-minute walk test
Time frame: first day
6-minute walk test were used to assess functional exercise capacity according to the guidelines. The test was repeated twice in the same day with 30 min interval. The highest distance was recorded for analysis.
6-minute stepper test
Time frame: second day
6-minute stepper test were used to assess functional exercise capacity according to the guidelines. The height of the stepper used for test was 20 cm. A cycle of up and down was define as one step. The number of steps was recorded for analysis.
Physical activity assessment
Time frame: second day
Total energy expenditure (joules/day), active energy expenditure (>3.0 metabolic equivalents (METs)) (joules/day), physical activity duration (>3.0 METs) (min/day), average MET (METs/day), number of steps (steps/day), lying down (min/day) and sleeping duration (min/day) were measured to interpret the physical activity level of the patients via metabolic holter device. The metabolic holter was worn over triceps brachii muscle of non-dominant extremity for two consecutive days. The patients' activity level were categorized according to number of steps and average MET sums.
9 secondary outcomes
Inspiratory muscle strength test
Time frame: first day
Expiratory muscle strength test
Time frame: first day
Peripheral muscle strength test
Time frame: first day
Inspiratory muscle endurance test
Time frame: second day
Modified borg scale
Time frame: first and second day
Quality of life scale
Time frame: first day
Fatigue
Time frame: second day
Dyspnea perception
Time frame: first day
Pain severity
Time frame: second day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Results publication: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Results publication: PubMed 26342839Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Impairments after curative intent treatment for non-small cell lung cancer: a comparison with age and gender-matched healthy controls. Respir Med. 2015 Oct;109(10):1332-9. doi: 10.1016/j.rmed.2015.08.015. Epub 2015 Aug 29.
- Results publication: PubMed 17976462Nagamatsu Y, Maeshiro K, Kimura NY, Nishi T, Shima I, Yamana H, Shirouzu K. Long-term recovery of exercise capacity and pulmonary function after lobectomy. J Thorac Cardiovasc Surg. 2007 Nov;134(5):1273-8. doi: 10.1016/j.jtcvs.2007.06.025.
- Results publication: PubMed 11093502Kaseda S, Aoki T, Hangai N, Shimizu K. Better pulmonary function and prognosis with video-assisted thoracic surgery than with thoracotomy. Ann Thorac Surg. 2000 Nov;70(5):1644-6. doi: 10.1016/s0003-4975(00)01909-3.
- Results publication: PubMed 28692471Cheng X, Onaitis MW, D'amico TA, Chen H. Minimally Invasive Thoracic Surgery 3.0: Lessons Learned From the History of Lung Cancer Surgery. Ann Surg. 2018 Jan;267(1):37-38. doi: 10.1097/SLA.0000000000002405. No abstract available.
- Results publication: PubMed 29921098Upham TC, Onaitis MW. Video-assisted thoracoscopic surgery versus robot-assisted thoracoscopic surgery versus thoracotomy for early-stage lung cancer. J Thorac Cardiovasc Surg. 2018 Jul;156(1):365-368. doi: 10.1016/j.jtcvs.2018.02.064. Epub 2018 Mar 2. No abstract available.
- Results publication: PubMed 26904225Park TY, Park YS. Long-term respiratory function recovery in patients with stage I lung cancer receiving video-assisted thoracic surgery versus thoracotomy. J Thorac Dis. 2016 Jan;8(1):161-8. doi: 10.3978/j.issn.2072-1439.2016.01.14.
- Results publication: PubMed 26597694Granger CL, Parry SM, Edbrooke L, Denehy L. Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management. Physiotherapy. 2016 Sep;102(3):256-63. doi: 10.1016/j.physio.2015.10.007. Epub 2015 Oct 23.
- Results publication: PubMed 27790715Schwartz RM, Yip R, Flores RM, Olkin I, Taioli E, Henschke C; I-ELCAP Investigators. The impact of resection method and patient factors on quality of life among stage IA non-small cell lung cancer surgical patients. J Surg Oncol. 2017 Feb;115(2):173-180. doi: 10.1002/jso.24478. Epub 2016 Oct 28.
- Results publication: PubMed 8205877Nomori H, Kobayashi R, Fuyuno G, Morinaga S, Yashima H. Preoperative respiratory muscle training. Assessment in thoracic surgery patients with special reference to postoperative pulmonary complications. Chest. 1994 Jun;105(6):1782-8. doi: 10.1378/chest.105.6.1782.
- 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. This study is not recruiting at the moment.
Ece BAYTOK, MsC. study chair
Gazi University
Zeliha ÇELİK, MsC. principal investigator
Gazi University
Merve ŞATIR TÜRK, MD. principal investigator
Gazi 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 VATS and Thoracotomy in people with Pulmonary Nodule, run by Gazi 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (Forced expiratory volume in one second) (time frame: first day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805723, which also lists 10 linked publications.
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 18 Mar 2021.