NCT01747694

Brief Summary

COPD patients often suffer from dyspnea and exercise intolerance which lower their quality of life.The aim of this proposed study is to examine the effectiveness of multi-respiratory muscle training on respiratory function of COPD patients.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 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

Study Start

First participant enrolled

December 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 12, 2012

Status Verified

October 1, 2012

Enrollment Period

8 months

First QC Date

December 10, 2012

Last Update Submit

December 10, 2012

Conditions

Keywords

COPD,Respiratory muscle training,Exercise tolerance

Outcome Measures

Primary Outcomes (1)

  • PE max

    maximal strength of expiratory muscle

    three months

Secondary Outcomes (3)

  • PI max

    three months

  • 6MWT

    three months

  • MVV

    three months

Other Outcomes (2)

  • St. George's Respiratory Questionnaire

    three months

  • CES-D

    three months

Study Arms (2)

Multi-respiratory muscle training

EXPERIMENTAL

Patients will perform multi-repiratory muscle training programe for 12 weeks

Behavioral: Multi-respiratory muscle training

Diaphragmatic breathing

NO INTERVENTION

Patients will be taught diaphragmatic breathing technique routinely. To practice at home lasting 12 weeks

Interventions

Patients will be taught the diaphragmatic breathing technique at the same time also will be instructed a four-item (including upper-arm weighted exercise, body side-bends, modified sit-ups, body crunching) multi-respiratory muscle training motions. To practice three times/day, three days a week lasting 12 weeks at home.

Multi-respiratory muscle training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Chronic Obstructive Pulmonary Disease
  • Must be stable
  • Never participate in respiratory muscle trainig program

You may not qualify if:

  • Infection or acute excerbation condition
  • Abdominal surgical
  • Severe neuromuscular, cardiac disease or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

RECRUITING

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

  • Shu-Chuan Ho, PhD

    Chang Gung Memorial Hospital

    STUDY CHAIR
  • Min-Fang Hsu, PhD student

    Department of Healthcare Administration,Asia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

December 12, 2012

Record last verified: 2012-10

Locations