COPD,NCT01549028
Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)
A study testing mobile-based PR program. in people with COPD, and Osteoporosis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of osteoporosis and fractures. Osteoporosis, however, may be equally as disabling as COPD, and may impair respiratory function even further if the patient experiences vertebral compressions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD,, Osteoporosis
- What is being tested?
- mobile-based PR program.
- 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
- Sep 2011to Dec 2014
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with chronic obstructive pulmonary disease.
- with osteoporosis.
Who cannot join
- could not receive six-minutes walking test.
- could not receive mobile-based pulmonary rehabilitation.
- acute exacerbation of COPD recent 3 months.
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
About this study
Official title: The Prevalence, Correlations and Effectiveness of Intervention of Osteoporosis in COPD Patients
Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of osteoporosis and fractures. Osteoporosis, however, may be equally as disabling as COPD, and may impair respiratory function even further if the patient experiences vertebral compressions.
In this study, we will survey the prevalence, correlations and effectiveness of intervention of osteoporosis in COPD patients.
Read the detailed description
COPD has a multiple etiology and organ impaired inflammatory disease. In clinical characteristic include airway inflammatory response, cili mobility impairment and lung consolidation change; the others change includes: other functional impairments such as malnutrition, body mass loss, osteogenesis and osteoporosis. The prevalence of osteoporosis and osteopenia patients is generally higher than in healthy subjects and some other chronic disease. Patients with chronic obstructive pulmonary disease are at increased risk of osteoporosis and fractures. Risk factors such as smoking, advanced age, physical inactivity, malnutrition, and low weight may be responsible, but a number of pathophysiological explanations including the presence of a chronic inflammatory state with increased levels of proinflammatory cytokines and protein catalytic enzymes may also be involved. The use of oral glucocorticoids is also a significant risk factor. Osteoporosis, however, may be equally as disabling as COPD, and may impair respiratory function even further if the patient experiences vertebral compressions and loss of height The number of patients with osteoporosis is rising and osteoprosis becomes an important medical and public health issue as the population gets older including Taiwan. Osteoporosis is a silent disease and it is thus important to screen for osteoporosis institute treatment an dreduce fracture incidence. In this study, we will survey the prevalence, correlations and effectiveness of intervention of osteoporosis in COPD patients. This study purpose hope can understand patient's osteoporosis status, pulmonary function impairment and exercise intolerance. Then, we may be can prevent the unnecessary of fracture and maintance of bone mineral contains by the pulmonary rehabilitation program training in osteoporosis COPD patients.
- Conditions
- COPD,, Osteoporosis
- Being tested
- mobile-based PR program.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile-based PR program.Behavioural
Patients will be trained and monitored by mobile-based pulmonary rehbailitation program. By mobile, patients could undergo exercise training at home and the information of training parameters will be send to investigator. Investigator could monitor these patients by mobile. Patients will return to visit physian and receive six-minutes walking test to measure outcomes 3 months and 1 year later after mobile-based pulmonary rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-based PR program. | Experimental | Home based mobile PR program for 3 months. Receives: Behavioral: mobile-based PR program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise tolerance.
Exercise tolerance will be measured by six-minutes walking test after trainsing with 3 months mobile-based pulmonary rehabilitation program. Wlaking distences will be the primary outcome measurement.
Measured: 3 months
Secondary outcomes (1)
Inflammatory cytokine of patients.
Inflammatory cytokine of enrolled patients including IL-6、IL-8、TNF-α \& CRP before and 3 months, 1 year after moble-based pulomonary rehabilitation program will be measured.
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPD,Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Shu-Chuan, Chang Gung Memorial Hospital
- Investigators
- Shu-Chuan Ho, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549028
- Sponsor's protocol ID
- 100-2225A3
- Status last verified
- Mar 2012
- First submitted
- 6 Mar 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu WT, Huang CD, Wang CH, Lee KY, Lin SM, Kuo HP. A mobile telephone-based interactive self-care system improves asthma control. Eur Respir J. 2011 Feb;37(2):310-7. doi: 10.1183/09031936.00000810. Epub 2010 Jun 18.
PubMed 20562122Liu WT, Wang CH, Lin HC, Lin SM, Lee KY, Lo YL, Hung SH, Chang YM, Chung KF, Kuo HP. Efficacy of a cell phone-based exercise programme for COPD. Eur Respir J. 2008 Sep;32(3):651-9. doi: 10.1183/09031936.00104407. Epub 2008 May 28.
PubMed 18508824
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence, Correlations and Effectiveness of Intervention of Osteoporosis in COPD Patients
- ClinicalTrials.gov ID
- NCT01549028
- Acronym / sponsor ID
- 100-2225A3
- Conditions
- COPD,, Osteoporosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Mar 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.
Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of osteoporosis and fractures. Osteoporosis, however, may be equally as disabling as COPD, and may impair respiratory function even further if the patient experiences vertebral compressions.
In this study, we will survey the prevalence, correlations and effectiveness of intervention of osteoporosis in COPD patients.
Detailed description
COPD has a multiple etiology and organ impaired inflammatory disease. In clinical characteristic include airway inflammatory response, cili mobility impairment and lung consolidation change; the others change includes: other functional impairments such as malnutrition, body mass loss, osteogenesis and osteoporosis. The prevalence of osteoporosis and osteopenia patients is generally higher than in healthy subjects and some other chronic disease. Patients with chronic obstructive pulmonary disease are at increased risk of osteoporosis and fractures. Risk factors such as smoking, advanced age, physical inactivity, malnutrition, and low weight may be responsible, but a number of pathophysiological explanations including the presence of a chronic inflammatory state with increased levels of proinflammatory cytokines and protein catalytic enzymes may also be involved. The use of oral glucocorticoids is also a significant risk factor. Osteoporosis, however, may be equally as disabling as COPD, and may impair respiratory function even further if the patient experiences vertebral compressions and loss of height The number of patients with osteoporosis is rising and osteoprosis becomes an important medical and public health issue as the population gets older including Taiwan. Osteoporosis is a silent disease and it is thus important to screen for osteoporosis institute treatment an dreduce fracture incidence. In this study, we will survey the prevalence, correlations and effectiveness of intervention of osteoporosis in COPD patients. This study purpose hope can understand patient's osteoporosis status, pulmonary function impairment and exercise intolerance. Then, we may be can prevent the unnecessary of fracture and maintance of bone mineral contains by the pulmonary rehabilitation program training in osteoporosis COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile-based PR program. | Experimental | Behavioral: mobile-based PR program.Home based mobile PR program for 3 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- with chronic obstructive pulmonary disease.
- with osteoporosis.
Key exclusion criteria (3 listed)
- could not receive six-minutes walking test.
- could not receive mobile-based pulmonary rehabilitation.
- acute exacerbation of COPD recent 3 months.
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 |
|---|---|---|
| mobile-based PR program.Patients will be trained and monitored by mobile-based pulmonary rehbailitation program. By mobile, patients could undergo exercise training at home and the information of training parameters will be send to investigator. Investigator could monitor these patients by mobile. Patients will return to visit physian and receive six-minutes walking test to measure outcomes 3 months and 1 year later after mobile-based pulmonary rehabilitation program. | Behavioural | Mobile-based PR program. |
Primary outcome
exercise tolerance.
Time frame: 3 months
Exercise tolerance will be measured by six-minutes walking test after trainsing with 3 months mobile-based pulmonary rehabilitation program. Wlaking distences will be the primary outcome measurement.
1 secondary outcome
Inflammatory cytokine of patients.
Time frame: 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Background: PubMed 20562122Liu WT, Huang CD, Wang CH, Lee KY, Lin SM, Kuo HP. A mobile telephone-based interactive self-care system improves asthma control. Eur Respir J. 2011 Feb;37(2):310-7. doi: 10.1183/09031936.00000810. Epub 2010 Jun 18.
- Background: PubMed 18508824Liu WT, Wang CH, Lin HC, Lin SM, Lee KY, Lo YL, Hung SH, Chang YM, Chung KF, Kuo HP. Efficacy of a cell phone-based exercise programme for COPD. Eur Respir J. 2008 Sep;32(3):651-9. doi: 10.1183/09031936.00104407. Epub 2008 May 28.
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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 principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile-based PR program. in people with COPD, and Osteoporosis, 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 2 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 8 Mar 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 (+886-3281200 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?
exercise tolerance. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01549028, which also lists 2 linked publications.
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 8 Mar 2012; AzTrials last refreshed its copy on 31 Oct 2026.