Effects of Inspiratory and Expiratory Pressure Training Methods in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease(COPD) Clinical Trial

Official title:

Effects of Inspiratory and Respiratory Pressure Threshold Training in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02326181
• Other study ID #: ZJH21400964
• Status: Not yet recruiting
• Phase: N/A
• First received: December 21, 2014
• Last updated: December 24, 2014
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: Zhujiang Hospital
• Contact: Liqing Wang, Doctor
• Phone: +86-02062783391
• Email: wliqing07[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease(COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• inspiratory pressure training group
The respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) .
• mixed training group
The respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) and expiration(EMST).

Locations

Country	Name	City	State
China	Zhujiang hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory muscle strength measurements		baseline and 8 weeks	Yes
Secondary	respiratory muscle endurance text		baseline and 8 weeks	Yes
Secondary	6-minute walking test		baseline and 12 weeks	Yes
Secondary	perceived exertion for leg fatigue (Borg-scale)		baseline and 8 weeks	Yes
Secondary	modified british medical research council(mMRC) questionnaire		baseline and 8 weeks	Yes