COPDNCT01747694
Respiratory Muscle Exercise Training in COPD Patients
A study testing Multi-respiratory muscle training in people with COPD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Multi-respiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease
- Must be stable
- Never participate in respiratory muscle trainig program
Who cannot join
- Infection or acute excerbation condition
- Abdominal surgical
- Severe neuromuscular, cardiac disease or dementia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Shu-Chuan Ho, PhD, +886-3-3281200 ext. 5068, sc6212.ho@msa.hinet.net
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Being tested
- Multi-respiratory muscle training
- Keywords
- COPD,Respiratory muscle training,Exercise tolerance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-respiratory muscle trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-respiratory muscle training | Experimental | Patients will perform multi-repiratory muscle training programe for 12 weeks Receives: Behavioral: Multi-respiratory muscle training |
| Diaphragmatic breathing | No intervention | Patients will be taught diaphragmatic breathing technique routinely. To practice at home lasting 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
PE max
maximal strength of expiratory muscle
Measured: three months
Secondary outcomes (3)
PI max
maximal strength of inspiratory muscle
Measured: three months
6MWT
six-minute walking test
Measured: three months
MVV
maximal voluntary volume
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Chuan Ho, PhD, Study chair, Chang Gung Memorial HospitalMin-Fang Hsu, PhD student, Principal investigator, Department of Healthcare Administration,Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747694
- Sponsor's protocol ID
- 101-2527A3
- Status last verified
- Oct 2012
- First submitted
- 10 Dec 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Multi-respiratory Muscle Training on Respiratory Function in Patients With COPD
- ClinicalTrials.gov ID
- NCT01747694
- Acronym / sponsor ID
- 101-2527A3
- Conditions
- COPD
- Keywords
- COPD,Respiratory muscle training,Exercise tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-respiratory muscle training | Experimental | Behavioral: Multi-respiratory muscle trainingPatients will perform multi-repiratory muscle training programe for 12 weeks |
| Diaphragmatic breathing | No intervention | –Patients will be taught diaphragmatic breathing technique routinely. To practice at home lasting 12 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Chronic Obstructive Pulmonary Disease
- Must be stable
- Never participate in respiratory muscle trainig program
Key exclusion criteria (3 listed)
- Infection or acute excerbation condition
- Abdominal surgical
- Severe neuromuscular, cardiac disease or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-respiratory muscle trainingPatients 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. | Behavioural | Multi-respiratory muscle training |
Primary outcome
PE max
Time frame: three months
maximal strength of expiratory muscle
3 secondary outcomes
PI max
Time frame: three months
6MWT
Time frame: three months
MVV
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Chuan Ho, PhD study chair
Chang Gung Memorial Hospital
Min-Fang Hsu, PhD student principal investigator
Department of Healthcare Administration,Asia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-respiratory muscle training in people with COPD, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Chuan Ho, PhD (+886+3+3281200 ext. 5068, sc6212.ho@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PE max (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012; AzTrials last refreshed its copy on 30 Oct 2026.