NCT02757092: VATSMIPMEP

The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery

Completed NA Results posted Last updated 3 November 2020

What this trial tests

NA trial testing Home-based Pulmonary Rehabilitation in Lung Neoplasms in 36 participants. Completed in 31 May 2017.

Timeline

31 March 2016

Primary endpoint
1 April 2017

31 May 2017

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	36
Start date	31 March 2016
Primary completion	1 April 2017
Estimated completion	31 May 2017
Sites	2 locations across Taiwan

Drugs / interventions tested

• Home-based Pulmonary Rehabilitation

Conditions studied

• Lung Neoplasms — all drugs for Lung Neoplasms →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 65 to 85, any sex, with Lung Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Discharge 2weeks Exercise Capacity Primary · 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

Group	Value	95% CI
Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc	408.61	± 62.85
The Control Group 2weeks Six-min Walking Distanc	311.94	± 84.65

Discharge 6 Weeks Exercise Capacity Primary · 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

Group	Value	95% CI
Pulmonary Rehabilitation Group 6 Weeks Six-min Walking Distanc	411.63	± 44.49
The Control Group 6 Weeks Six-min Walking Distanc	332.94	± 54.03

Discharge 12 Weeks Exercise Capacity Primary · 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

Group	Value	95% CI
Pulmonary Rehabilitation group12 Weeks Six-min Walking Distanc	397.06	± 50.37
The Control Group 12 Weeks Six-min Walking Distanc	345.17	± 46.04

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

Group	Value	95% CI
Pulmonary Rehabilitation Group 2 Weeks FVC (Liter(L)/Sec)	2.48	± 0.80
The Control Group 2 Weeks FVC(Liter(L)/Sec))	2.00	± 0.85

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

Group	Value	95% CI
Pulmonary Rehabilitation Group 2 Weeks FEV1 (Liter(L)/Sec)	1.97	± 0.54
The Control Group 2 Weeks FEV1(Liter(L)/Sec)	1.57	± 0.69

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

Group	Value	95% CI
Pulmonary Rehabilitation Group	2.00	± 0.81
The Control Group	1.58	± 0.94

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

Group	Value	95% CI
Pulmonary Rehabilitation Group	5.68	± 2.35
The Control Group	4.27	± 2.35

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

Group	Value	95% CI
Pulmonary Rehabilitation Group 2 Weeks MIP(cmH2O)	90.00	± 25.66
The Control Group 2weeks MIP (cmH2O)	67.33	± 28.15

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

Group	Value	95% CI
Pulmonary Rehabilitation Group 2 Weeks MEP(cmH2O)	89.44	± 28.79
The Control Group 2weeks MEP(cmH2O)	68.89	± 22.72

Discharge 2 Weeks Modified Borg Score Secondary · 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

Group	Value	95% CI
Pulmonary Rehabilitation Group 2 weeksModified Borg Score	1.06	± 0.54
The Control Group 2weeks Modified Borg Score	1.72	± 0.67

Discharge 2weeks Lung Expansion Capacity Secondary · 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.

Group	Value	95% CI
Pulmonary Rehabilitation	1450.00	± 619.53
Control Group	1033.33	± 388.65

Postoperative 2 Weeks Pulmonary Complications Secondary · 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.

pneumonia

Group	Value	95% CI
Pulmonary Rehabilitation	0
Control Group	1

atelectasis

Group	Value	95% CI
Pulmonary Rehabilitation	1
Control Group	2

pleural effusion

Group	Value	95% CI
Pulmonary Rehabilitation	0
Control Group	1

emphysema

Group	Value	95% CI
Pulmonary Rehabilitation	0
Control Group	1

pulmonary infilation

Group	Value	95% CI
Pulmonary Rehabilitation	1
Control Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: we collect 12 weeks of adverse event data. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pulmonary Rehabilitation Group

Serious: 0/18 (0%)

Deaths: 0/18

The Control Group

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (1 terms — click to expand)

Reaction	System	Pulmonary Rehabilitation G…	The Control Group
Prolonged air leak (PAL)	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT02757092 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Physical Activity and Exercise in Lung Cancer Care: Will Promises Be Fulfilled?
   Avancini A, Sartori G, Gkountakos A, Casali M, et al · · 2020 · cited 120× · PMID 32162811 · DOI 10.1634/theoncologist.2019-0463