Clinical trial NCT03551197: Change of Lung Function After Exercise in Patients With Chronic Obstructive Pulmonary Disease
Official title: Impact of Exercise on Lung Function in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Exercise
Lung Function Decreased
Quality of Life
Keywords: Pulmonary Disease, Chronic Obstructive
exercise
lung function
quality of life
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is only one group.Patients with diagnosis of Chronic Obstructive Pulmonary Disease are recruited.Subjects will be examined at baseline and after 3 months' treatment of budesonide and formoterol.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the changes of lung function before and after the exercise in patients with chronic obstructive pulmonary disease.The assessment of quality of life is also carried out through questionnaires.

Detailed description: This is a randomized,open-label study to research the changes of lung function before and after exercise in patients with chronic obstructive pulmonary disease .At baseline,lung function test,blood oxygen saturation and pulse are measured before and after 6-min walk test for each subject.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ),Clinical Chronic Obstructive Pulmonary Questionnaire(CCQ) and chronic obstructive pulmonary assessment test(CAT).And then budesonide(160ug) and formoterol(4.5ug) bid will be given to the subjects for 3 months.The subjects will have a follow-up visit with all the examinations mentioned above after 3 months' treatment.

Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 to 80 years-old, inclusive.
* A clinical diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines.
* Post bronchodilator (following inhalation of salbutamol) forced expired volume in one second(FEV1)/forced vital capacity(FVC) ratio ≤0.70.
* Willing and able to provide written informed consent.
* Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion Criteria:

* Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions including unstable ischemic heart disease,unstable cardiac arrhythmia or heart failure,life threatening arrhythmias,etc.
* Recent history of chronic obstructive pulmonary disease exacerbation requiring hospitalization or need for increased treatments for chronic obstructive pulmonary disease within 6 weeks.

Primary outcomes:
measure: Changes of forced expired volume in one second(FEV1) after 6-min walk test compared with resting state
timeFrame: At resting state and after 6-min walk test
Secondary outcomes:
measure: Changes of inspiratory capacity(IC) after 6-min walk test compared with resting state
timeFrame: At resting state and after 6-min walk test
measure: Changes of blood oxygen saturation after 6-min walk test compared with resting state
timeFrame: At resting state and after 6-min walk test
measure: Changes of pulse after 6-min walk test compared with resting state
timeFrame: At resting state and after 6-min walk test
measure: Changes of forced expired volume in one second(FEV1) after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Changes of inspiratory capacity(IC) after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Changes of diffusion function after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Changes of impulse forced oscillometry parameters after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Changes of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Changes of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Changes of clinical chronic obstructive pulmonary questionnaire(CCQ) scores after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: Changes of chronic obstructive pulmonary disease assessment test(CAT) scores after 3 months' treatment compared with baseline
timeFrame: Change from baseline to 3 months
measure: The distance and steps of 6-min walk test
timeFrame: Change from baseline to 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Huapeng Yu
role: PRINCIPAL_INVESTIGATOR
References: