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NCT Number: NCT02757092

The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery

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.

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Key information

Conditions

Lung Neoplasms Behavior Lung Diseases Motor Activity Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Kaohsiung City, Niaosong, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec)

    Time frame: assessments at 2 weeks after discharge

    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. Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)

    Time frame: assessed at 2 weeks after discharge

    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.

  3. Discharge 2weeks MMEF 25-75%(Liter(L)/Sec)

    Time frame: assessed at discharge 2weeks

    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.

  4. Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec)

    Time frame: assessed at discharge 2weeks

    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.

  5. Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O)

    Time frame: assessed at discharge 2 weeks.

    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.

  6. Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O)

    Time frame: assessed at discharge 2 weeks

    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.

  7. Discharge 2 Weeks Modified Borg Score

    Time frame: assessed at discharge 2 weeks

    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

  8. Discharge 2weeks Lung Expansion Capacity

    Time frame: assessed at discharge 2 weeks

    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.

  9. Postoperative 2 Weeks Pulmonary Complications

    Time frame: at 2weeks after discharge

    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.

  10. Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec)

    Time frame: assessments at discharge 6 weeks

    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.

  11. Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec)

    Time frame: assessed at discharge 6weeks

    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.

  12. Discharge 6weeks MMEF 25-75%(Liter(L)/Sec)

    Time frame: assessed at discharge 6 weeks

    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.

  13. Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec)

    Time frame: assessed at discharge .6weeks

    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.

  14. Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O)

    Time frame: assessed at discharge6 weeks.

    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.

  15. Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O)

    Time frame: assessed at discharge 6 weeks

    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.

  16. Discharge 6 Weeks Modified Borg Score

    Time frame: assessed at discharge 6week

    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

  17. Discharge 6weeks Lung Expansion Capacity

    Time frame: assessed at discharge 6 weeks

    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.

  18. Postoperative 6weeks Pulmonary Complications

    Time frame: at 6weeks after discharge

    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.

  19. Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec )

    Time frame: assessments at discharge 12 weeks

    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.

  20. Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)

    Time frame: assessed at discharge12weeks

    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.

  21. Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec)

    Time frame: assessed at discharge12weeks "

    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.

  22. Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec)

    Time frame: assessed at discharge 12 weeks

    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.

  23. Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O)

    Time frame: assessed at discharge12 weeks.

    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.

  24. Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O)

    Time frame: assessed at discharge 12weeks

    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.

  25. Discharge 12 Weeks Modified Borg Score

    Time frame: assessed at discharge12weeks

    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

  26. Discharge 12 Weeks Lung Expansion Capacity

    Time frame: assessed at discharge 12weeks

    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.

  27. Postoperative 12 Weeks Pulmonary Complications

    Time frame: at 12 weeks after discharge

    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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Efficacy of Home-Based Pulmonary Rehabilitation Training in Aged Patients With Lung Tumor After Video-assisted Thoracic Surgery:A Clinical Randomized Trial

Acronym: VATSMIPMEP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Nov 3, 2020

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