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The advantages of thoracoscopic surgery include smaller wounds, fewer postoperative complications, and shortened hospital stay. However,complications such as pain, pulmonary function insufficiency, pneumonia,postoperative pneumothorax, persistent air leakage, subcutaneous emphysema, cough, and hemoptysis may occur in older patients after thoracoscopic surgery. Pulmonary rehabilitation has been demonstrated by evidence-base medicine could effectively reduce pulmonary complications and dyspnea as well as improve lung function, quality of life, exercise ability, and functional status of patients after traditional heart and thoracic surgery. Studies have suggested that pulmonary rehabilitation should be performed for at least 4 weeks to optimize the training effect .However, most patients who undergo thoracoscopic surgery were discharged within 3-5 days. Such a short hospital stay impeded the delivery of pulmonary rehabilitation. Home-based pulmonary rehabilitation appeared to be an option for these patients The purpose of this study is to determine whether Pulmonary rehabilitation are effective on patients who had thoracic surgeries.
Pulmonary-related surgeries remain some potential risks according to the previous evidence-based studies. Particularly, individuals who were over 65 years of age with smoking, chronic pulmonary disease, wheezy, cardiovascular comorbidities, upper respiratory infection were at the high risk of pulmonary complications after surgery,which accounted for approximately 2% to 40% of occurrence rate. The average mortality rate due to surgery was approximately 2%-8% in patients aged more than 65 years.Pulmonary rehabilitation could effectively reduce pulmonary complications and dyspnea as well as improve lung function, quality of life, exercise ability, and functional status of patients after traditional heart and thoracic surgery.But efficacy of home-based pulmonary rehabilitation for older adults following thoracoscopic surgery, it has not received much attention.
This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in older adults after VATS. All participants underwent preoperative and initial postoperative pulmonary rehabilitation during their hospital stay and were randomly assigned to the experimental or control group at the time of discharge. The control group received standard health education, whereas the experimental group received home-based pulmonary rehabilitation in addition to standard health education. Objective and personal subjective outcome measurements were performed before hospital discharge and 2, 6, and 12 weeks after discharge The control group received standard care. Considering the principle for exercise progression, we divided the home-based rehabilitation program into two stages (0-2 weeks and 3-6 weeks).The exercise program was adjusted in the second week when patients visited the outpatient department of the hospital for follow-up. The home-based rehabilitation program included (1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure.
In the second stage (3-6 weeks), the aerobic exercise intensity was targeted to reach 12-15 points on the RPE scale. Patients performed upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day as well as walking exercise (slow walking for 5 min and fast walking for 2 min, followed by 5-min slow walking, for a total of 30 min). Incentive spirometry training (Triflo-II) was performed 8-10 times per hour, and a threshold load trainer was used to train the inspiratory muscle (30 breaths each time, twice per day), with the pressure intensity adjusted to more than 5% of that in the first stage.Researchers contacted patients at home every week through phone calls to monitor the occurrence of any uncomfortable reaction and to encourage patients to continue their rehabilitation program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based rehabilitation program | Experimental | 0-2 weeks,1. aerobic exercise intensity was targeted to reach 10-11 points of perceived exercise (RPE) scale 2. raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min 3.walked at a comfortable speed for 15 min twice per day.4. Triflo-II was performed 8-10 times per hour. inspiratory muscle training with the initial pressure set at 25%-30% of the maximum inspiratory pressure.3-6 weeks, aerobic exercise reach 12-15 points on the RPE scale. upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day , walking exercise for a total of 30 min. Triflo-II was performed 8-10 times per hour, and train the inspiratory muscle with the pressure intensity adjusted to more than 5% of that in the first stage. |
|
| standard care | Active Comparator | control group accept the pulmonary rehabilitation (breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Pulmonary Rehabilitation | Other | (1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge 2weeks Exercise Capacity | Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome. | assessed at discharge 2weeks |
| Discharge 6 Weeks Exercise Capacity | Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome. | assessed at discharge.6weeks |
| Discharge 12 Weeks Exercise Capacity | Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M).higher scores mean a better outcome. | assessed at discharge 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec) | Forced vital capacity (FVC in L/sec) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 L/sec,and for females from 3.25-2.5 L/sec ,and whether higher scores mean a better outcome. | assessments at 2 weeks after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jui Fang Liu, PhD | Department of Respiratory Therapy | Study Director |
| Nai Ying Kuo, master | Department of Respiratory Therapy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kaohsiung City | Niaosong | 83342 | Taiwan | ||
| Chang Gung Memorial Hospital |
Share Protocol and Outcome deta
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The study was design a Prospective randomized control trial,and enrolled a total of 36 older patients with lung tumors after thoracoscopic surgery in the cardiothoracic and vascular ordinary ward between March 31 2016 to April 1 2017. The study was performed conducted in Kaohsiung Chang Gung Memorial Hospital, Taiwan
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Pulmonary Rehabilitation Group | Pulmonary Rehabilitation group accept the pulmonary rehabilitation( breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy ) in operation stage on before op-day 3 day and after op-day 2 weeks and keep home based pulmonary rehabilitation on discharge 2 weeks, 6 weeks and after 12 weeks. study group : received pain medication and standard care |
| FG001 | Study Group | study group accept the pulmonary rehabilitation( breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy ) in operation stage on before op-day 3 day and after op-day ,after discharged received standard care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pearson chi-square test was used for sex. comorbidities and smoking, Student's t-test was used for age, body weight . Body Mass Index, and total hospital days, Data is presented as either n(%) or mean ± SD.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulmonary Rehabilitation Group | arm group accept the pulmonary rehabilitation( smoking cession before operation, breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) in operation stage on before op-day 3 day and after op-day 2 weeks and keep home based pulmonary rehabilitation on discharge 2 weeks, 6 weeks and after 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | After signing the consent form, each case subject was randomly divided assigned into either the control or the experimental group on the day of discharge.Inclusion criteria were: 1) Older than or equal to 65 years with an established diagnosis of Lung tumor.2)admission to receive video-assisted thoracoscopic surgery 3.)conscious and able to communicate, and 4.)Able to undergo six weeks of home-based pulmonary rehabilitation program. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Discharge 2weeks Exercise Capacity | Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for exercise capacity.an intention-to-treat analysis was performed.group × time interactions were observed for the 6-min walking distance. | Posted | Mean | Standard Deviation | meter(M) | assessed at discharge 2weeks |
|
we collect 12 weeks of adverse event data
Before discharge,If air leakage occurs before discharge, we definition it as an adverse event, because it may extend the patient's hospital stay.After discharge, home-based rehabilitation program design as a low-to-medium intensity and non-invasive .Researchers contacted patients at home every week through phone calls to monitor the occurrence of any uncomfortable reaction and post-op 2weeks,6weeks and 12weeks regular check CXR .PFT. 6min walking test and respiratory muscle power .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pulmonary Rehabilitation Group | 0-2 weeks, the aerobic exercise intensity was targeted to reach 10-11 points of RPE scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day.Triflo-II was performed 8-10 times per hour. inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure. 3-6 weeks, the aerobic exercise intensity was targeted to reach 12-15 points on the RPE scale. Patients performed upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day as well as walking exercise (slow walking for 5 min and fast walking for 2 min, followed by 5-min slow walking, for a total of 30 min).Triflo-II was performed 8-10 times per hour, and inspiratory muscle training, with the pressure intensity adjusted to more than 5% of that in the first stage. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged air leak (PAL) | Surgical and medical procedures | Prolonged air leak | Systematic Assessment | Prolonged air leak (PAL) is one of the most common postoperative complications after pulmonary resection Pleural adhesion was associated with increased risk of PAL ,and will prolong hospital stay after surgery. |
First,sample size is low,this may affect the result of the study;secondly, pulmonary function should collect DLCO and MVV;third,although the patients were checked via telephone every week,there is no surefire way to enforce intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory therapist Nai-Ying Kuo | Chang Gung Memorial Hospital | +886077317123 | 2648 | ellen0605@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2016 | Apr 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in patients after thoracoscopy. After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge. The random assignment was performed based on simple randomization by using numbers from 1 to 36; numbered, sealed, opaque envelopes were used for allocation concealment. These envelopes were randomly distributed by non researchers and recorded.
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After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge
|
| Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec) |
The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome. |
| assessed at 2 weeks after discharge |
| Discharge 2weeks MMEF 25-75%(Liter(L)/Sec) | Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome. | assessed at discharge 2weeks |
| Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec) | Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome. | assessed at discharge 2weeks |
| Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O) | Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome. | assessed at discharge 2 weeks. |
| Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O) | The Maximal Expiratory Pressure (MEP) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cmH2O is always abnormal, and higher scores mean a better outcome. | assessed at discharge 2 weeks |
| Discharge 2 Weeks Modified Borg Score | Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome | assessed at discharge 2 weeks |
| Discharge 2weeks Lung Expansion Capacity | Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (ml).higher scores mean a better outcome. | assessed at discharge 2 weeks |
| Postoperative 2 Weeks Pulmonary Complications | Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18. | at 2weeks after discharge |
| Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec) | Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome. | assessments at discharge 6 weeks |
| Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec) | The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome. | assessed at discharge 6weeks |
| Discharge 6weeks MMEF 25-75%(Liter(L)/Sec) | Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome. | assessed at discharge 6 weeks |
| Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec) | Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome. | assessed at discharge .6weeks |
| Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O) | Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome. | assessed at discharge6 weeks. |
| Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O) | The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome. | assessed at discharge 6 weeks |
| Discharge 6 Weeks Modified Borg Score | Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome | assessed at discharge 6week |
| Discharge 6weeks Lung Expansion Capacity | Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome. | assessed at discharge 6 weeks |
| Postoperative 6weeks Pulmonary Complications | Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.In our research,some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18. | at 6weeks after discharge |
| Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec ) | Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome. | assessments at discharge 12 weeks |
| Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec) | The Forced Expiratory Volume in 1 Second parameter(FEV1,liter(L)/sec) measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome. | assessed at discharge12weeks |
| Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec) | Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome. | assessed at discharge12weeks " |
| Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec) | Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome. | assessed at discharge 12 weeks |
| Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O) | Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome. | assessed at discharge12 weeks. |
| Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O) | The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome. | assessed at discharge 12weeks |
| Discharge 12 Weeks Modified Borg Score | Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome | assessed at discharge12weeks |
| Discharge 12 Weeks Lung Expansion Capacity | Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome. | assessed at discharge 12weeks |
| Postoperative 12 Weeks Pulmonary Complications | Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18. | at 12 weeks after discharge |
| Kaohsiung City |
| 83342 |
| Taiwan |
| BG001 | The Control Group | The control group received pain medication and usual care. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Pearson chi-square test was used for sex,deta is presented as either n(%) or mean +-SD | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | enrolled a total of 36 older patients with lung tumors after thoracoscopic surgery in the cardiothoracic and vascular ordinary ward in Taiwan | Count of Participants | Participants |
|
| BMI (Kg/m2) | Student's t-test was used for Body Mass Index .Data is presented as either n(%) or mean ± SD. | Mean | Standard Deviation | Kg/m2 |
|
| BW (kg) | Student's t-test was used for body weight. Data is presented as either n(%) or mean ± SD. | Mean | Standard Deviation | kg |
|
| Amount of comorbidities | Pearson chi-square test was used for sex. comorbidities and smoking, Data is presented as either n(%) or mean ± SD. | Count of Participants | Participants |
|
| smoking | Count of Participants | Participants |
|
| total hospital days | Student's t-test was used for total hospital days, Data is presented as either n(%) or mean ± SD | Mean | Standard Deviation | days |
|
| PFT | Student's t-test was used for FVC .Data is presented as either n(%) or mean ± SD. | Mean | Standard Deviation | liter/sec |
|
| FEV1/FVC(%) | Measure Description: Student's t-test was used for FEV1/FVC(%).Data is presented as either n(%) or mean ± SD.The FEV1/FVC ratio is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC) The result of this ratio is expressed as FEV1%.Normal values are approximately 75%.values less than 0.70 are suggestive of airflow limitation with an obstructive pattern | Mean | Standard Deviation | % |
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| Modified Borg score | Student's t-test was used for Modified Borg score .Data is presented as mean ± SD.Scores on a scale that ranges from 1 to 10,Larger numbers indicate more severe breathing difficulties,the opposite is the smaller the number, the lower the dyspnea is | Mean | Standard Deviation | scores on a scale |
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| MIP(cmH2O) | Student's t-test was used for MIP/MEP Data is presented as either n(%) or mean ± SD. | Mean | Standard Deviation | cmH2O |
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| MEP(cmH2O) | Student's t-test was used for MIP/MEP Data is presented as either n(%) or mean ± SD. | Mean | Standard Deviation | cmH20 |
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| Lung capacity (mL/sec) | Lung capacity measure by incentive spirometry (Triflow) , The flow-oriented incentive spirometer (Triflow device) consists of three chambers in series, each of which contains a ball.An inspiratory flow of 600 mL/sec is required to raise the first ball, an inspiratory flow of 900 mL/sec is required to elevate the first and second balls, and a flow of 1200 mL/sec is required to elevate all three balls.The time of the ball stays longer was mean the better lung capacity | Mean | Standard Deviation | mL |
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| 6-min walk test(meter,M) | The 6MWT is a useful measure of functional capacity targeted at people with at least moderately severe impairment. The test has been widely used for preoperative and postoperative evaluation and for measuring the response to therapeutic interventions for pulmonary and cardiac disease.In healthy subjects, the 6-min walk distance (6MWD) ranges from 400 to 700 m, the main predictor variables being gender, age and height.The longer distance was mean the better functional capacity ability,<250 m does predict poorer outcome | Mean | Standard Deviation | meter |
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| Anesthesia time(min) | Student's t-test was used for Anesthesia time | Mean | Standard Deviation | min |
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| American Society of Anesthesiologists (ASA) score | Student's t-test was used for ASA score. Data is presented as mean ± SD.Scores on a scale that ranges from 1 to 6. ASA 1: A normal healthy patient. ASA 2: A patient with a mild systemic disease. ASA 3: A patient with a severe systemic disease that is not life-threatening. ASA 4: A patient with a severe systemic disease that is a constant threat to life. ASA 5: A moribund patient who is not expected to survive without the operation. ASA 6: A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient. | Mean | Standard Deviation | scores on a scale |
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| Surgery time(min) | Student's t-test was used for Surgery time , Data is presented as either n(%) or mean ± SD. | Mean | Standard Deviation | min |
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| chest tube placement time(hours) | Student's t-test was used for Chest tube placement time, Data is presented as either n(%) or mean ± SD. | Mean | Standard Deviation | hours |
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| surgery method | Count of Participants | Participants |
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| wedge resection | Count of Participants | Participants |
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| surgery site | Pearson chi-square test was used for surgery site. Data is presented as either n(%) or mean ± SD. Some patients have operation two lobes at the same time, so the total is not necessarily equal to 18. | Count of Participants | Participants |
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| postoperative diagnosis | Pearson chi-square test was used for postoperative diagnosis.Data is presented as either n(%) or mean ± SD. | Count of Participants | Participants |
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| postoperative stages of lung cancer | Pearson chi-square test was used postoperative stages of lung cancer. Surgery time and Chest tube placement time, Data is presented as either n(%) or mean ± SD.StageI:Cancer may be present in the underlying lung tissues, but the lymph nodes remain unaffected. StageII:The cancer may have spread to nearby lymph nodes or into the chest wall.StageIII:The cancer is continuing to spread from the lungs to the lymph nodes or to nearby structures and organs.Stage IV: the cancer has metastasized, or spread, beyond the lungs into other areas of the body,the last stages of cancer means the more serious | Count of Participants | Participants |
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| postoperative complications | Count of Participants | Participants |
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Each subject received six-min walking distance assessments at discharge 2 weeks after discharge |
| OG001 | The Control Group 2weeks Six-min Walking Distanc | Each subject received six-min walking distance assessments at discharge 2 weeks after discharge |
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| Primary | Discharge 6 Weeks Exercise Capacity | Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for exercise capacity. For group comparisons, an intention-to-treat analysis was performed.group × time interactions were observed for the 6-min walking distance. | Posted | Mean | Standard Deviation | meter(M) | assessed at discharge.6weeks |
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| Primary | Discharge 12 Weeks Exercise Capacity | Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M).higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for exercise capacity. For group comparisons, an intention-to-treat analysis was performed. group × time interactions were observed for the 6-min walking distance. | Posted | Mean | Standard Deviation | meter(M) | assessed at discharge 12 weeks |
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| Secondary | Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec) | Forced vital capacity (FVC in L/sec) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 L/sec,and for females from 3.25-2.5 L/sec ,and whether higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessments at 2 weeks after discharge |
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| Secondary | Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec) | The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at 2 weeks after discharge |
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| Secondary | Discharge 2weeks MMEF 25-75%(Liter(L)/Sec) | Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge 2weeks |
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| Secondary | Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec) | Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge 2weeks |
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| Secondary | Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O) | Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome. | Two-way repeated measures ANOVA for MIP. For group comparisons, an intention-to-treat analysis was performed. group × time interactions were observed for the MIP | Posted | Mean | Standard Deviation | cmH2O | assessed at discharge 2 weeks. |
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| Secondary | Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O) | The Maximal Expiratory Pressure (MEP) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cmH2O is always abnormal, and higher scores mean a better outcome. | Two-way repeated measures ANOVA for MEP. an intention-to-treat analysis was performed.group × time interactions were observed for the MEP | Posted | Mean | Standard Deviation | cmH2O | assessed at discharge 2 weeks |
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| Secondary | Discharge 2 Weeks Modified Borg Score | Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome | Two-way repeated measures ANOVA for Modified Borg score.an intention-to-treat analysis was performed.group × time interactions were observed for the Modified Borg score | Posted | Mean | Standard Deviation | scores on a scale | assessed at discharge 2 weeks |
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| Secondary | Discharge 2weeks Lung Expansion Capacity | Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (ml).higher scores mean a better outcome. | Two-way repeated measures ANOVA for Lung expansion capacity. an intention-to-treat analysis was performed.group × time interactions were observed for the Lung expansion capacity. | Posted | Mean | Standard Deviation | (ml) | assessed at discharge 2 weeks |
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| Secondary | Postoperative 2 Weeks Pulmonary Complications | Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18. | Pearson chi-square test was used for Pulmonary complication on discharge 2 weeks .Data is presented as either n(%). | Posted | Count of Participants | Participants | at 2weeks after discharge |
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| Secondary | Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec) | Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter( L)/sec | assessments at discharge 6 weeks |
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| Secondary | Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec) | The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge 6weeks |
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| Secondary | Discharge 6weeks MMEF 25-75%(Liter(L)/Sec) | Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge 6 weeks |
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| Secondary | Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec) | Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge .6weeks |
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| Secondary | Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O) | Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome. | Two-way repeated measures ANOVA for MIP. an intention-to-treat analysis was performed.group × time interactions were observed for the MIP | Posted | Mean | Standard Deviation | cmH2O | assessed at discharge6 weeks. |
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| Secondary | Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O) | The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome. | Two-way repeated measures ANOVA for MEP. an intention-to-treat analysis was performed.group × time interactions were observed for the MEP | Posted | Mean | Standard Deviation | cmH2O | assessed at discharge 6 weeks |
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| Secondary | Discharge 6 Weeks Modified Borg Score | Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome | Two-way repeated measures ANOVA for Modified Borg score.an intention-to-treat analysis was performed.group × time interactions were observed for the Modified Borg score | Posted | Mean | Standard Deviation | scores on a scale | assessed at discharge 6week |
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| Secondary | Discharge 6weeks Lung Expansion Capacity | Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome. | Two-way repeated measures ANOVA for Lung expansion capacity. an intention-to-treat analysis was performed.group × time interactions were observed for the Lung expansion capacity | Posted | Mean | Standard Deviation | (ml) | assessed at discharge 6 weeks |
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| Secondary | Postoperative 6weeks Pulmonary Complications | Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.In our research,some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18. | Pearson chi-square test was used for Pulmonary complication on discharge 6 weeks .Data is presented as n(%). | Posted | Count of Participants | Participants | at 6weeks after discharge |
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| Secondary | Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec ) | Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome. | .2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter( L)/sec | assessments at discharge 12 weeks |
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| Secondary | Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec) | The Forced Expiratory Volume in 1 Second parameter(FEV1,liter(L)/sec) measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge12weeks |
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| Secondary | Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec) | Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge12weeks " |
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| Secondary | Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec) | Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome. | 2-WAY repeated measures ANOVA method was used for pulmonary function test. | Posted | Mean | Standard Deviation | liter(L)/sec | assessed at discharge 12 weeks |
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| Secondary | Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O) | Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome. | Two-way repeated measures ANOVA for MIP. an intention-to-treat analysis was performed.group × time interactions were observed for the MIP | Posted | Mean | Standard Deviation | cmH2O | assessed at discharge12 weeks. |
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| Secondary | Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O) | The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome. | Two-way repeated measures ANOVA for MEP. an intention-to-treat analysis was performed.group × time interactions were observed for the MEP | Posted | Mean | Standard Deviation | cmH2O | assessed at discharge 12weeks |
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| Secondary | Discharge 12 Weeks Modified Borg Score | Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome | Two-way repeated measures ANOVA for Modified Borg score. an intention-to-treat analysis was performed.group × time interactions were observed for the Modified Borg score | Posted | Mean | Standard Deviation | scores on a scale | assessed at discharge12weeks |
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| Secondary | Discharge 12 Weeks Lung Expansion Capacity | Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome. | Two-way repeated measures ANOVA for Lung expansion capacity. an intention-to-treat analysis was performed.group × time interactions were observed for the Lung expansion capacity | Posted | Mean | Standard Deviation | (ml) | assessed at discharge 12weeks |
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| Secondary | Postoperative 12 Weeks Pulmonary Complications | Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18. | Pearson chi-square test was used for Pulmonary complication on discharge 12 weeks .Data is presented as n(%). | Posted | Count of Participants | Participants | at 12 weeks after discharge |
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| 0 |
| 18 |
| 0 |
| 18 |
| 6 |
| 18 |
| EG001 | The Control Group | The control group accept the pulmonary rehabilitation , breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation. | 0 | 18 | 0 | 18 | 6 | 18 |
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Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001519 | Behavior |
| sefmentectomy |
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| pleural effusion |
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| emphysema |
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| pulmonary infilation |
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| pleural effusion |
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| emphysema |
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| pulmonary infilation |
|
| pleural effusion |
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| emphysema |
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| pulmonary infilation |
|