Lung NeoplasmsVATSMIPMEPNCT02757092
The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery
A study testing Home-based Pulmonary Rehabilitation in people with Lung Neoplasms, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Home-based Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesTaiwan
- Study dates
- 31 Mar 2016to 31 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Signed consent
- The men and women over the age of 65
- admission to undergo VATS.
- consciousness and ability to communicate
- ability to undergo 6 weeks of a home-based pulmonary rehabilitation program
Who cannot join
- refusal to participate
- unplanned emergency surgery
- hemodynamic instability
- received other surgery within a month postsurgery
- unconsciousness after surgery
- bedridden and upper or lower limb weakness
- received radiation and chemotherapy postsurgery
- implementation of thoracoscopic surgery for biopsy only
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Chang Gung Memorial Hospital
Kaohsiung City, Niaosong, 83342
Chang Gung Memorial Hospital
Kaohsiung City, 83342
About this study
Official title: The Efficacy of Home-Based Pulmonary Rehabilitation Training in Aged Patients With Lung Tumor After Video-assisted Thoracic Surgery:A Clinical Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Lung Neoplasms
- Being tested
- Home-based Pulmonary Rehabilitation
- Keywords
- Pulmonary rehabilitation, surgery, exercise
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Pulmonary RehabilitationOther
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home-based Pulmonary Rehabilitation |
| 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. Receives: Other: Home-based Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: assessed at discharge 12 weeks
Secondary outcomes (27)
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.
Measured: assessments at 2 weeks after 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: at 12 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start31 Mar 2016
- Primary completion1 Apr 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Jui Fang, Chang Gung Memorial Hospital
- Investigators
- Jui Fang Liu, PhD, Study director, Department of Respiratory TherapyNai Ying Kuo, master, Study chair, Department of Respiratory Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757092
- Sponsor's protocol ID
- 1046659A3
- Acronym
- VATSMIPMEP
- Status last verified
- Oct 2020
- First submitted
- 12 Apr 2016
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Share Protocol and Outcome deta
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Home-Based Pulmonary Rehabilitation Training in Aged Patients With Lung Tumor After Video-assisted Thoracic Surgery:A Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT02757092
- Acronym / sponsor ID
- VATSMIPMEP / 1046659A3
- Conditions
- Lung Neoplasms
- Keywords
- Pulmonary rehabilitation, surgery, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 3 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home-based rehabilitation program | Experimental | Other: Home-based Pulmonary Rehabilitation0-2 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 | Other: Home-based Pulmonary Rehabilitationcontrol 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Signed consent
- The men and women over the age of 65
- admission to undergo VATS.
- consciousness and ability to communicate
- ability to undergo 6 weeks of a home-based pulmonary rehabilitation program
Key exclusion criteria (8 listed)
- refusal to participate
- unplanned emergency surgery
- hemodynamic instability
- received other surgery within a month postsurgery
- unconsciousness after surgery
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 |
|---|---|---|
| Home-based Pulmonary Rehabilitation(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. | Other | Home-based rehabilitation program, standard care |
Primary outcome
Discharge 2weeks Exercise Capacity
Time frame: assessed at discharge 2weeks
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.
Discharge 6 Weeks Exercise Capacity
Time frame: assessed at discharge.6weeks
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.
Discharge 12 Weeks Exercise Capacity
Time frame: assessed at discharge 12 weeks
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.
27 secondary outcomes
Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec)
Time frame: assessments at 2 weeks after discharge
Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)
Time frame: assessed at 2 weeks after discharge
Discharge 2weeks MMEF 25-75%(Liter(L)/Sec)
Time frame: assessed at discharge 2weeks
Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec)
Time frame: assessed at discharge 2weeks
Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O)
Time frame: assessed at discharge 2 weeks.
Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O)
Time frame: assessed at discharge 2 weeks
Discharge 2 Weeks Modified Borg Score
Time frame: assessed at discharge 2 weeks
Discharge 2weeks Lung Expansion Capacity
Time frame: assessed at discharge 2 weeks
Postoperative 2 Weeks Pulmonary Complications
Time frame: at 2weeks after discharge
Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec)
Time frame: assessments at discharge 6 weeks
Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec)
Time frame: assessed at discharge 6weeks
Discharge 6weeks MMEF 25-75%(Liter(L)/Sec)
Time frame: assessed at discharge 6 weeks
Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec)
Time frame: assessed at discharge .6weeks
Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O)
Time frame: assessed at discharge6 weeks.
Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O)
Time frame: assessed at discharge 6 weeks
Discharge 6 Weeks Modified Borg Score
Time frame: assessed at discharge 6week
Discharge 6weeks Lung Expansion Capacity
Time frame: assessed at discharge 6 weeks
Postoperative 6weeks Pulmonary Complications
Time frame: at 6weeks after discharge
Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec )
Time frame: assessments at discharge 12 weeks
Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)
Time frame: assessed at discharge12weeks
Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec)
Time frame: assessed at discharge12weeks "
Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec)
Time frame: assessed at discharge 12 weeks
Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O)
Time frame: assessed at discharge12 weeks.
Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O)
Time frame: assessed at discharge 12weeks
Discharge 12 Weeks Modified Borg Score
Time frame: assessed at discharge12weeks
Discharge 12 Weeks Lung Expansion Capacity
Time frame: assessed at discharge 12weeks
Postoperative 12 Weeks Pulmonary Complications
Time frame: at 12 weeks after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Share Protocol and Outcome deta
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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.
Jui Fang Liu, PhD study director
Department of Respiratory Therapy
Nai Ying Kuo, master study chair
Department of Respiratory Therapy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Pulmonary Rehabilitation in people with Lung Neoplasms, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Discharge 2weeks Exercise Capacity (time frame: assessed at discharge 2weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.