Respiratory Muscle Exercise Training in COPD Patients

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014