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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease(COPD)
• Intervention / Treatment: Device: inspiratory pressure training group; Device: mixed training group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liqing Wang, Doctor; Phone Number: +86-02062783391; Email: wliqing07@gmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Zhujiang Hospital
      • Contact: Liqing Wang; Phone Number: 86-02062783391; Email: wliqing07@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; without inspiratory and expiratory pressure threshold training
Experimental: inspiratory pressure training group; The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer.	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) .
Experimental: mixed training group; The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
respiratory muscle strength measurements	baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
respiratory muscle endurance text	baseline and 8 weeks
6-minute walking test	baseline and 12 weeks
perceived exertion for leg fatigue (Borg-scale)	baseline and 8 weeks
modified british medical research council(mMRC) questionnaire	baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Xin Chen, Doctor, Zhujiang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 21, 2014
• First Submitted That Met QC Criteria: December 24, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Estimate): December 25, 2014
• Last Update Submitted That Met QC Criteria: December 24, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: respiratory muscle strength; respiratory muscle training; 6-minute walking test; respiratory endurance test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ZJH21400964