Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 6, 2012 | ||||
| Last Updated Date | March 7, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
exercise tolerance. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] 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. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01549028 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Inflammatory cytokine of patients. [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ] 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. |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Official Title ICMJE | The Prevalence, Correlations and Effectiveness of Intervention of Osteoporosis in COPD Patients | ||||
| Brief 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. 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 Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Behavioral: 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. |
||||
| Study Arm (s) | Experimental: Mobile-based PR program.
Home based mobile PR program for 3 months.
Intervention: Behavioral: mobile-based PR program. |
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01549028 | ||||
| Other Study ID Numbers ICMJE | 100-2225A3 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ho Shu-Chuan, Chang Gung Memorial Hospital | ||||
| Study Sponsor ICMJE | Chang Gung Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Chang Gung Memorial Hospital | ||||
| Verification Date | March 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||