- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01747694
Respiratory Muscle Exercise Training in COPD Patients
December 10, 2012 updated by: Chang Gung Memorial Hospital
The Effectiveness of Multi-respiratory Muscle Training on Respiratory Function in Patients With COPD
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shu-Chuan Ho, PhD
- Phone Number: 5068 +886+3+3281200
- Email: sc6212.ho@msa.hinet.net
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Recruiting
- Chang Gung Memorial Hospital
-
Contact:
- Shu-Chuan Ho, PhD
- Phone Number: 5068 +886-3-3281200
- Email: sc6212.ho@msa.hinet.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multi-respiratory muscle training
Patients will perform multi-repiratory muscle training programe for 12 weeks
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PE max
Time Frame: three months
|
maximal strength of expiratory muscle
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PI max
Time Frame: three months
|
maximal strength of inspiratory muscle
|
three months
|
6MWT
Time Frame: three months
|
six-minute walking test
|
three months
|
MVV
Time Frame: three months
|
maximal voluntary volume
|
three months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
St. George's Respiratory Questionnaire
Time Frame: three months
|
Disease-Specific quality of life
|
three months
|
CES-D
Time Frame: three months
|
assessment of depressive status
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shu-Chuan Ho, PhD, Chang Gung Memorial Hospital
- Principal Investigator: Min-Fang Hsu, PhD student, Department of Healthcare Administration,Asia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
October 1, 2013
Study Registration Dates
First Submitted
December 10, 2012
First Submitted That Met QC Criteria
December 10, 2012
First Posted (Estimate)
December 12, 2012
Study Record Updates
Last Update Posted (Estimate)
December 12, 2012
Last Update Submitted That Met QC Criteria
December 10, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 101-2527A3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD
-
University Medical Center GroningenCompleted
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Not yet recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
University Hospital, BrestRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Baylor Research InstituteNot yet recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
Clinical Trials on Multi-respiratory muscle training
-
Marmara UniversityCompleted
-
Abant Izzet Baysal UniversityNot yet recruitingChronic Obstructive Pulmonary Disease
-
Institute of Sport - National Research Institute...CompletedAthletic PerformancePoland
-
Institute of Sport - National Research Institute...Enrolling by invitationRespiratory Muscle TrainingPoland
-
Faculdade de Ciências Médicas da Santa Casa de...Completed
-
University of the State of Santa CatarinaCompletedHeart Diseases | Cardiovascular Diseases | Coronary Disease | Coronary Artery Occlusion
-
University of FloridaCompleted
-
Universidade Federal de PernambucoCompletedMuscular Atrophy | Aging | Sensitivity Training GroupsBrazil
-
Vanderbilt University Medical CenterNot yet recruitingDysphagia | Heart Transplant Recipients
-
University Hospital, GrenobleCompleted