Respiratory Muscle Exercise Training in COPD Patients

This study is currently recruiting participants.
Verified October 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01747694
First received: December 10, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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 Intervention
COPD
Behavioral: Multi-respiratory muscle training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Multi-respiratory Muscle Training on Respiratory Function in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • PE max [ Time Frame: three months ] [ Designated as safety issue: No ]
    maximal strength of expiratory muscle


Secondary Outcome Measures:
  • PI max [ Time Frame: three months ] [ Designated as safety issue: No ]
    maximal strength of inspiratory muscle

  • 6MWT [ Time Frame: three months ] [ Designated as safety issue: No ]
    six-minute walking test

  • MVV [ Time Frame: three months ] [ Designated as safety issue: No ]
    maximal voluntary volume


Other Outcome Measures:
  • St. George's Respiratory Questionnaire [ Time Frame: three months ] [ Designated as safety issue: No ]
    Disease-Specific quality of life

  • CES-D [ Time Frame: three months ] [ Designated as safety issue: No ]
    assessment of depressive status


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747694

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

Locations
Taiwan
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
Investigators
Study Chair: Shu-Chuan Ho, PhD Chang Gung Memorial Hospital
Principal Investigator: Min-Fang Hsu, PhD student Department of Healthcare Administration,Asia University
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01747694     History of Changes
Other Study ID Numbers: 101-2527A3
Study First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: Taiwan: Institutional Review Board

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

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014