Clinical trial NCT02326181: Effects of Inspiratory and Expiratory Pressure Training Methods in Patients With Chronic Obstructive Pulmonary Disease
Official title: Effects of Inspiratory and Respiratory Pressure Threshold Training in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease(COPD)
Keywords: respiratory muscle training
respiratory muscle strength
respiratory endurance test
6-minute walking test
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with inspiratory pressure threshold training would be better than inspiratory pressure threshold training alone, with regard to exercise capacity, respiratory muscle strength and endurance.

Detailed description: We will study 60 patients diagnosed of chronic obstructive pulmonary disease.The monitoring will be done for 8 weeks. Pressure-threshold respiratory trainers were calibrated to provide different loads according to the patients against inspiration (IMST) or expiration (EMST). Those chronic obstructive pulmonary disease clinically stable patients stratified from mild to very severe GOLD stages, were blinded to randomly divided into 3 different groups: a)control group:without any training;b) inspiratory and expiratory pressure threshold training group: trained with the pressure threshold trainer twice time daily with 15minutes' duration;c)inspiratory pressure threshold training group:trained with the pressure threshold trainer twice time daily with 15 minutes' duration,different from the b group,the expiratory pressure threshold is calibrated at 0.

Eligibility criteria: Inclusion Criteria:

Clinically stable COPD with diagnosis of forced expiratory volume at one second(FEV1)/forced vital capacity(FVC) \< 70%

Exclusion Criteria:

Cancer Unstable heart disease Neuromusculoskeletal disorder mental disorder Active smokers

Primary outcomes:
measure: respiratory muscle strength measurements
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: respiratory muscle endurance text
timeFrame: baseline and 8 weeks
measure: 6-minute walking test
timeFrame: baseline and 12 weeks
measure: perceived exertion for leg fatigue (Borg-scale)
timeFrame: baseline and 8 weeks
measure: modified british medical research council(mMRC) questionnaire
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Xin Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu W, Li R, Guan L, Wang K, Hu Y, Xu L, Zhou L, Chen R, Chen X. Combination of inspiratory and expiratory muscle training in same respiratory cycle versus different cycles in COPD patients: a randomized trial. Respir Res. 2018 Nov 20;19(1):225. doi: 10.1186/s12931-018-0917-6.