NCT02326181

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

December 21, 2014

Last Update Submit

December 24, 2014

Conditions

Keywords

respiratory muscle trainingrespiratory muscle strengthrespiratory endurance test6-minute walking test

Outcome Measures

Primary Outcomes (1)

  • respiratory muscle strength measurements

    baseline and 8 weeks

Secondary Outcomes (4)

  • 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

Study Arms (3)

control group

NO INTERVENTION

without inspiratory and expiratory pressure threshold training

inspiratory pressure training group

EXPERIMENTAL

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

Device: inspiratory pressure training group

mixed training group

EXPERIMENTAL

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

Device: mixed training group

Interventions

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) .

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) and expiration(EMST).

mixed training group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cancer Unstable heart disease Neuromusculoskeletal disorder mental disorder Active smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang hospital

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xin Chen, Doctor

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liqing Wang, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2014

First Posted

December 25, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations