The Rehabilitary Effect And Mechanism Of Respiratory Rehabilitation Valve On Stable COPD Patients

Background:Chronic obstructive pulmonary disease（COPD）is a kind of chronic airway inflammational diseases with irreversible airflow limitation and persistent clinical symptoms.Patients with COPD have always been accompanied by various degrees of dyspnea,limb muscle dysfunction,motor restriction and so on,which seriously influence the quality of life and prognosis.Pulmonary rehabilitation,including general exercise,respiratory muscle training,effective cough and sputum removal,nutritional therapy and psychological recovery,is an important non-drug treatment for patients with COPD.And it has been proved to improve patients’exercise tolerance,dyspnea symptoms,the quality of life and so on.Respiratory muscle training is an important part of Pulmonary Rehabilitation,because patients with COPD have always been accompanied by respiratory muscle dysfunction.In addition,airway mucus hypersecretion is closely related to acute exacerbation and prognosis of COPD patients.How to improve effective cough and sputum drainage is an important part of clinical work.Factors affecting drainage of airway secretions in COPD include small airway obstruction,ability of cough clearance and airway mucus fluidity.Based on the objectives of training respiratory muscle and increasing airway mucus fluidity,in this study,this self-designed respiratory rehabilitation valve（Respiratory Valve）is based on expiratory resistance,positive expiratory pressure and oscillatory which is also featured by simplicity in use,portability and adjustable threshold pressure loading.Previous clinical research indicates that it is helpful to improve the clinical symptoms of the patients.Objectives:to explore the rehabilitary effect of respiratory valve on stable COPD patients and respiratory physiology response during using Respiratory Valve,and to provide a new method for respiratory rehabilitation.Part One:The effects rehabilitation of Respiratory Valve in the stable patients with COPD:a randomized controlled crossover trialObjects:Moderate to very severe stable patients with COPD from March 2017 to January 2018 in the Respiratory Department of the first affiliated Hospital of Guangzhou Medical University were collected.The diagnosis of COPD was confirmed by admission symptoms,signs and pulmonary function examination,which was in accordance with the COPD diagnosis and treatment guidelines formulated by the 2013 Chinese Medical Association Respiratory Society.Methods:Basic examinations of all patients included CAT questionnaire,COPD clinical questionnaire,mMRC,SGRQ,6-minute walking test,Borg score,cough-expectoration symptom score and pulmonary function.Eligible patients were randomly divided into two groups:group A and group B,and cross-controlled study was carried out.Group A:in the first stage of the study,the breathing valve was used to exercise:setting the maximum load level of valve,holding the breathing valve flat,forcefully inhaling,exhaling forcefully with mouthpiece wrapped tightly by mouth,inhale again and repeating the above circulation.In the second stage of the study,breathing exercise was performed with PLB:after a forcefully inhale,exhale slowly with lips pursed like whistling.Repeat at least 50breathing cycles per 30minutes a time and 3 times a day,active cough after every 5breathing cycles or active coughing during which rest was allowed.The order in group B is the opposite of that in group A.Each phase of the study lasted 2 weeks.There is an elution period of 2 weeks after each stage.The related indexes were followed up every 2weeks.The regimen remained unchanged during the study.Results:1.Baseline demographic and clinical characteristicsA total of 31 stable COPD patients（all males）were enrolled in the study,13 COPD patients complete the second part studies and 2 case were lost to follow-up in group A,while 11 COPD patients complete the second part studies and 5 case were lost to follow-up in group B;The baseline demographic of the group A and the group B patients had no significant difference before admitted to the study（P>0.05）.2.The effect of having breathing exercise by Respiratory Valve and PLB inpulmonary function（1）The indexes of pulmonary function were not significantly changed after training byRespiratory Valve（P>0.05）.（2）The indexes of pulmonary function were not significantly changed after PLB training（P>0.05）.（3）Compared with PLB training,there was no significant difference in the change of lungfunction before and after training by Respiratory Valve（P>0.05）.3.The effect of having breathing exercise by Respiratory Valve and PLB in symptoms（1）After breathing exercising with Respiratory Valve,mMRC and cough-expectoration ymptom score were decreased,but there was no statistical significance compared ith before rehabilitation（P>0.05）.（2）After breathing exercising by PLB,mMRC were decreased,but there was no statistical ignificance compared with before rehabilitation（P>0.05）.The cough-expectoration ymptom score had no significant change.（3）Compared with PLB training,the improvement in mMRC and cough-expectoration ymptom of patients using Respiratory Valve was better,but there was no significant ifference（P>0.05）.4.The effect of having breathing exercise by Respiratory Valve and PLB in quality of life（1）After using Respiratory Valve to rehabilitation,total scores of CAT,CCQ and SGRQ ere decreased and statistical significance was observed compared with before ehabilitation（P<0.05）.Symptom scores of CCQ and symptom,activities,effect cores of SGRQ had significant improvement（P<0.05）.（2）After using PLB to rehabilitation,total scores of CAT,CCQ and SGRQ were slightly eclined but no statistical significance were observed（P>0.05）.（3）Compared with PLB training,the improvement range of CAT and CCQ in Respiratory alve had no significant difference（P>0.05）,but total scores of SGRQ have ignificant improvement（P<0.05）.5.The effect of having breathing exercise by Respiratory Valve and PLB in 6 MWD and Borg（1）After using Respiratory Valve to rehabilitation,6 MWD was increased（8.13±21.33m） ut had no statistical significance compared with before rehabilitation（P>0.05）.Borg had no significant change.（2）After using PLB to rehabilitation,6 MWD was increased（16.50±31.43m）and tatistical significance was observed（P<0.05）.Borg had no significant change.（3）There was no obvious statistical significance between the improvement in 6 MWD and org of patients using Respiratory Valve and PLB training（P>0.05）.Part Two:The effects of Respiratory Rehabilitation Valve in the stable patients with COPD:a parallel,randomized controlled studyObjects:Moderate to very severe stable patients with COPD from May 2017 to January2018 in the Respiratory Department of the first affiliated Hospital of Guangzhou Medical University were collected.The diagnosis of COPD was confirmed by admission symptoms,signs and pulmonary function examination,which was in accordance with the COPD diagnosis and treatment guidelines formulated by the 2013 Chinese Medical Association Respiratory Society.Methods:Basic examinations of all patients included CAT questionnaire,COPD clinical questionnaire,mMRC,6-minute walking test,Borg score,cough-expectoration symptom score and pulmonary function.Eligible patients were randomly divided into Respiratory Valve group,PLB group and control group.（1）Respiratory Valve group:combine routine medicine therapy with Breathing Valve training.The patient sets the maximum load level of valve,holds the breathing valve flat,forcefully inhales,exhales forcefully with mouthpiece wrapped tightly by mouth,inhales again and repeating the above circulation.（2）PLB group:combine routine medicine therapy with PLB training.PLB is a breathing technique that consists of exhaling through tightly pressed（pursed）lips and inhaling forcefully.（3）Control group:only routine medicine therapy.Quantitative training:3 times a day,at least 50 movements completed in each 30min,during which rest is allowed.According to the patient’s condition,SPO₂ should be kept above 88%.The three groups of patients returned to hospital after 3 months of admission to review the relevant indicators.Results:1.Baseline demographic and clinical characteristicsA total of 45 stable COPD patients were enrolled in the study,14 COPD patients completed the second part studies in Respiratory Valve group,2 case were lost to follow-up;11 COPD patients completed the second part studies in PLB group,3 case were lost to follow-up;13 COPD patients completed the second part studies in control group,2 case were lost to follow-up;The Baseline demographic of the 3 groups patients had no significant statistical difference before admitted to the study（P>0.05）.But weight and PIF had significant statistical difference（P<0.05）.2.The effect of having breathing exercise by Respiratory Valve and PLB in ulmonary functionAfter 3 months rehabilitation,PIF and IC of Respiratory Valve group were higher than before and had significant statistical difference（P<0.05）.PIF of PLB group was lower than before and has significant statistical difference（P<0.05）.Other pulmonary function indexes of Respiratory Valve group and PLB group had no significant statistical difference（P>0.05）.All pulmonary function indexes of control group had no significant change（P>0.05）.Compared with control group,IC of PLB group raised（0.14±0.32L）and has significant statistical difference（P<0.05）;IC and PIF of PLB group raise（0.12±0.18L,0.56±0.66L）and had significant statistical difference（P<0.05）.Other pulmonary function indexes of Respiratory Valve group and PLB group had no significant statistical difference（P>0.05）.Compared with PLB group,improvement value of PIF in Respiratory Valve group had significant statistical difference（P<0.05）,but other pulmonary function indexes of Respiratory Valve group and PLB group had no significant statistical difference（P>0.05）.3.The effect of having breathing exercise by Respiratory Valve and PLB in mMRCAfter 3 months rehabilitation,mMRC of Respiratory Valve group and PLB group were increased but had no significant statistical difference（P>0.05）.mMRC of control group had no obvious change（P>0.05）.There was no significant difference among the three groups（P>0.05）.4.The effect of having breathing exercise by Respiratory Valve and PLB in cough-xpectoration symptom scoreAfter 3 months rehabilitation,cough-expectoration symptom score of Respiratory Valve group was decreased and had statistical significance（P<0.05）.The score of PLB group and control group were slight increased but had no significant statistical difference（P>0.05）.Compared with control group,cough-expectoration symptom score of Respiratory Valve group was decreased and statistical significance was observerd（P<0.05）but not in PLB group（P>0.05）.Respiratory Valve group and PLB group had no significant statistical difference（P>0.05）.5.The effect of having breathing exercise by Respiratory Valve and PLB in CATAfter 3 months rehabilitation,CAT of Respiratory Valve group was significant decreased（-4.14±4.00 scores,P<0.05）.CAT of PLB group and control group had no obvious change（P>0.5）.Compared with control group,CAT of Respiratory Valve group was decreased and has obvious change（P<0.05）.There was no significant difference between Respiratory Valve group and PLB group（P>0.05）.6.The effect of having breathing exercise by Respiratory Valve and PLB in SGRQAfter 3 months rehabilitation,the totle SGRQ scores and each aspects（symptom aspect,activities aspect,effect aspect）of Respiratory Valve group was decreased（-9.00±14.70,-15.50±19.52,-4.00±16.13,-9.36±16.54）,in which the totle SGRQ scores and symptom aspect had obvious change（P<0.05）,but the others had no significant difference（P>0.05）;The totle SGRQ scores and each aspects（symptom aspect,activities aspect,effect aspect）of PLB group was decreased（-5.09±19.67,-5.73±26.50,-7.64±20.34,-3.36±21.03）,but had no significant difference（P>0.05）.The totle SGRQ scores and each aspects（symptom aspect,activities aspect,effect aspect）of control group had no obvious change（P>0.05）.There was no significant difference among the three groups（P>0.05）.7.The effect of Respiratory Valve and PLB in 6MWD and Borg after 6MWD testAfter 3 months rehabilitation,6MWD of Respiratory Valve group had significant improvement（46.54±56.37m,P<0.05）;6MWD of PLB group improved（11.73±59.01m）without significant difference（P>0.05）.6MWD of control group had no obvious change（P>0.05）.Compared with control group,improvement value of Respiratory Valve group’s6MWD had significant difference（P<0.05）;improvement in 6MWD of PLB group had no significant difference（P>0.05）.There was no significant difference between Respiratory Valve group and PLB group（P>0.05）.There was no significant difference among the three groups（P>0.05）.Part Three:Study on the respiratory physiology response in the application of Respiratory Rehabilitation ValveObjects:To include 8 moderate to very severe COPD outpatients in stable clinical condition and 8 healthy volunteers.Methods:8 cases of stable outpatients with COPD and 8 cases of healthy volunteers were placed the multichannel stomach esophagus balloon electrode tube through nasal cavity and surface electrode in abdominal muscle.First,the pressure,flow and electromyography data were recorded in calm breathing state.And then let the subjects in proper order complete PLB,control valve exercise,breathing valve exercise（low,medium,high,maximum load level）,try each set of 5-10 reps with appropriate rest between each set and try all these sets to the end in this way.The changes of indexes during exercise were measured in real time.Results:1.Expiratory pressure changes of using Respiratory Valve in different load levels（1）Normal subjects and COPD subjects perform exhalation at low,medium,high and ximum load levels through the inside of the valve,there was no significant ifference（P>0.05）in the change of P1_{end-exspiratory} and P1_max.（2）In the process of expiration with Respiratory Valve of the normal,there was a positive orrelation between PEF and the maximum P1（r=0.922,P<0.001）.In the COPD atients,there was also a positive correlation between PEF and the maximum 1（r=0.930,P<0.001）.（3）When normal subjects and COPD subjects perform exhalation at high and maximum oad levels through the inside of the valve,there were no significant difference（P>0.05）in the oscillation frequency and amplitude of proximeal pressure P1.There was o significant difference（P>0.05）in the oscillation frequency and amplitude of distal ressure P2 at four load levels through the inside of the valve,but there was significant ifference（P<0.05）in the oscillation frequency and amplitude of distal pressure flow.2.Inspiratory muscle function parameters changes of having breathing exercise by Respiratory Valve and PLBCompared with calm breathing in inspiratory phase,PTPdi of the normal taking PLB was increased and the change was statistically significant（P<0.05）.The absolute value of Peso,PTPdi,RMSdi,EMGdi%max of the normal taking control valves and Respiratory Valves（maximum load level）were increased and the difference of them were statistically significant（P<0.05）,but Pgas and Pdi were no statistically significant.Significant difference was not observed in diaphragm function parameters（RMSdi,EMGdi%max,Peso,Pgas,Pdi,PTPdi）changes among of the normal taking PLB,control valves,Respiratory Valves（maximum load level）（P>0.05）.Compared with calm breathing in inspiratory phase,the EMGdi%max of the COPD patients taking PLB and Respiratory Valve（maximum load level）were increased and had statistical significance（P<0.05）,not in the rest（P>0.05）.There was no significant difference in diaphragm function parameters（RMSdi,EMGdi%max,Peso,Pgas,Pdi,PTPdi）changes among of he COPD taking PLB,control valves,Respiratory Valves（maximum load level）（P>0.05）.3.Expiratory muscle function parameters changes of having breathing exercise by espiratory Valve and PLBCompared with calm breathing in expiratory phase,PTPgas of the normal taking PLB was increased and had statistical significance（P<0.05）,the absolute value of Peso,Pgas and PTPgas of the normal taking control valves,was increased and had statistical significance（P<0.05）,the absolute value of Peso,Pgas,RMSab,EMGab%max and PTPgas of the normal taking Respiratory Valves（maximum load level）were increased and had statistical significance（P<0.05）.Compared with PLB,when the normal take Respiratory Valves（maximum load level）,the absolute value of Peso and Pgas had statistical significance（P<0.05）,not in the rest（P>0.05）.There was no significant difference in expiratory muscle function parameters（RMSab,EMGab%max,Peso,Pgas,PTPgas）changes among the normal taking control valves,Respiratory Valves（maximum load level）（P>0.05）.Compared with calm breathing in expiratory phase,the absolute value of Peso,of the COPD patients taking PLB was increased and had statistical significance（P<0.05）,the absolute value of Peso,Pgas,RMSab,EMGab%max and PTPgas of the normal taking control valves and Respiratory Valves（maximum load level）were increased and had statistical significance（P<0.05）.Compared with PLB,when the COPD take Respiratory Valves at the four load levels,expiratory muscle function parameters were increased and had statistical significance,in which only the absolute value of Pgas and PTPgas of control valves had statistical significance（P<0.05）.But there was no significant difference in expiratory muscle function parameters（RMSab,EMGab%max,Peso,Pgas,PTPgas）changes among of the COPD patients taking control valves and Respiratory Valves（maximum load level）（P>0.05）.4.Ventilation function parameters changes of having breathing exercise by Respiratory Valve and PLBCompared with calm breathing,in the process of the normal taking PLB,Vt,Ti,Te and Ttot were increased,but Vt/Te,Ti/Ttot and SPO₂ were decreased,in which Vt,Te,Ttot and Ti/Ttot had statistical significance（P<0.05）.When the normal take control valves Vt and take Respiratory Valves Vt,Vt/Ti and Vt/Te were increased and had statistical significance（P<0.05）.Compared with PLB,Vt/Te and Ttot of the normal taking control valves and Vt,Te,Ttot,Vt/Ti and Vt/Te of taking Respiratory Valves had statistical significance（P<0.05）.There was no significant difference in ventilation function parameters（Vt,Ti,Te,Ttot,Ti/Ttot,Vt/Ti,Vt/Te,SPO₂）changes among the normal taking control valves and Respiratory Valves（maximum load level）（P>0.05）.Compared with calm breathing,in the process of the COPD patients taking PLB,Vt,Te and Ttot were increased,but Ti/Ttot was decreased,have statistical significance（P<0.05）.In the process of the COPD patients taking breathing exercise by control valves,Vt,Ti,Te,Ttot and Vt/T were increased,but Ti/Ttot was decreased,there had statistical significance（P<0.05）.In the process of the COPD patients taking Respiratory Valves（maximum load level）,Vt,Ti,Te,Ttot and Vt/Ti were increased,but Ti/Ttot was decreased,they had statistical significance（P<0.05）.Compared with PLB,Vt/Ti of the COPD patients taking control valves and Respiratory Valves were increased and had statistical significance（P<0.05）,but there was no significant difference in the rest（P>0.05）.There was no significant difference in ventilation function parameters（Vt,Ti,Te,Ttot,Ti/Ttot,Vt/Ti,Vt/Te,SPO₂）changes betweent the COPD taking control valves and Respiratory Valves（maximum load level）（P>0.05）.Conclusion:1.Training by respiratory rehabilitation valve 2 weeks could improve the quality of life f stable patients with COPD,but could not improve patients’lung function,dyspnea, ough and sputum symptoms and exercise ability.2.The recovery effect of respiratory rehabilitation valve was better than that of PLB. raining by Respiratory Valve for 3 months could improve IC and PIF,cough and putum symptom,quality of life,exercise endurance.3.The respiratory rehabilitation valve can provide positive expiratory pressure load of bout 1-20cmH₂O,and breath concussion can be produced by exhalation at the peak oad level of the breathing valve（mean frequency 9.66±4.23HZ,mean amplitude .80±2.40cm H₂O）.4.The process of rehabilitation by respiratory rehabilitation valve can train the iaphragm and expiratory muscle;PLB train expiratory muscle unevidently.5.Tidal volume was increased in the process of rehabilitation by Respiratory Valve, hich were the same as PLB.And PIF was increased only in the process of ehabilitation by Respiratory Valve.Therefore,rehabilitation valve can fully use the diaphragm and expiratory muscles,Increasethe tidal volume and mean inspiratory flow to promote airway secretion displacement,and creat expiratory oscillationto promote clearance of airway secretionsby promote cilia movement.