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

Primary Purpose

Chronic Obstructive Pulmonary Disease(COPD)

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
inspiratory pressure training group
mixed training group
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease(COPD) focused on measuring respiratory muscle training, respiratory muscle strength, respiratory endurance test, 6-minute walking test

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhujiang hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

inspiratory pressure training group

mixed training group

Arm Description

without inspiratory and expiratory pressure threshold training

The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer.

The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer.

Outcomes

Primary Outcome Measures

respiratory muscle strength measurements

Secondary Outcome Measures

respiratory muscle endurance text
6-minute walking test
perceived exertion for leg fatigue (Borg-scale)
modified british medical research council(mMRC) questionnaire

Full Information

First Posted
December 21, 2014
Last Updated
December 24, 2014
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02326181
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease(COPD)
Keywords
respiratory muscle training, respiratory muscle strength, respiratory endurance test, 6-minute walking test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
without inspiratory and expiratory pressure threshold training
Arm Title
inspiratory pressure training group
Arm Type
Experimental
Arm Description
The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer.
Arm Title
mixed training group
Arm Type
Experimental
Arm Description
The patients will perform daily in 2 sessions of 30 minutes, using a pressure threshold trainer.
Intervention Type
Device
Intervention Name(s)
inspiratory pressure training group
Intervention Description
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) .
Intervention Type
Device
Intervention Name(s)
mixed training group
Intervention Description
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).
Primary Outcome Measure Information:
Title
respiratory muscle strength measurements
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
respiratory muscle endurance text
Time Frame
baseline and 8 weeks
Title
6-minute walking test
Time Frame
baseline and 12 weeks
Title
perceived exertion for leg fatigue (Borg-scale)
Time Frame
baseline and 8 weeks
Title
modified british medical research council(mMRC) questionnaire
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liqing Wang, Doctor
Phone
+86-02062783391
Email
wliqing07@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Chen, Doctor
Organizational Affiliation
Zhujiang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqing Wang
Phone
86-02062783391
Email
wliqing07@gmail.com
First Name & Middle Initial & Last Name & Degree
Xin Chen

12. IPD Sharing Statement

Citations:
PubMed Identifier
30458805
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.
Results Reference
derived

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

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