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Respiratory Muscle Exercise Training in COPD Patients

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ClinicalTrials.gov Identifier: NCT01747694
Recruitment Status : Unknown
Verified October 2012 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 12, 2012
Last Update Posted : December 12, 2012
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment
COPD Behavioral: Multi-respiratory muscle training

Detailed Description:
The respiratory muscle training is an important part of pulmonary rehabilitation. Subjects will be recruited from the chest medicine clinic of a medical center in Northern Taiwan, randomly assigned to control and experimental groups by severity status for a 12-week muscle training intervention.The outcome measures will be performed to evaluate respiratory function, depression status and quality of life at baseline, 4, 8 and 12 weeks of training.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Multi-respiratory Muscle Training on Respiratory Function in Patients With COPD
Study Start Date : December 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Multi-respiratory muscle training
Patients will perform multi-repiratory muscle training programe for 12 weeks
Behavioral: Multi-respiratory muscle training
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.
No Intervention: Diaphragmatic breathing
Patients will be taught diaphragmatic breathing technique routinely. To practice at home lasting 12 weeks

Primary Outcome Measures :
  1. PE max [ Time Frame: three months ]
    maximal strength of expiratory muscle

Secondary Outcome Measures :
  1. PI max [ Time Frame: three months ]
    maximal strength of inspiratory muscle

  2. 6MWT [ Time Frame: three months ]
    six-minute walking test

  3. MVV [ Time Frame: three months ]
    maximal voluntary volume

Other Outcome Measures:
  1. St. George's Respiratory Questionnaire [ Time Frame: three months ]
    Disease-Specific quality of life

  2. CES-D [ Time Frame: three months ]
    assessment of depressive status

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747694

Contact: Shu-Chuan Ho, PhD +886+3+3281200 ext 5068 sc6212.ho@msa.hinet.net

Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shu-Chuan Ho, PhD    +886-3-3281200 ext 5068    sc6212.ho@msa.hinet.net   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Study Chair: Shu-Chuan Ho, PhD Chang Gung Memorial Hospital
Principal Investigator: Min-Fang Hsu, PhD student Department of Healthcare Administration,Asia University

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01747694     History of Changes
Other Study ID Numbers: 101-2527A3
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: October 2012

Keywords provided by Chang Gung Memorial Hospital:
COPD,Respiratory muscle training,Exercise tolerance