Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
COPD, Osteoporosis |
Behavioral: mobile-based PR program. |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Prevalence, Correlations and Effectiveness of Intervention of Osteoporosis in COPD Patients |
- 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.
- 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.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mobile-based PR program.
Home based mobile PR program for 3 months.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- with chronic obstructive pulmonary disease.
- with osteoporosis.
Exclusion Criteria:
- could not receive six-minutes walking test.
- could not receive mobile-based pulmonary rehabilitation.
- acute exacerbation of COPD recent 3 months.
Contacts and Locations| Contact: Shu-Chuan Ho, PhD | +886-3281200 ext 5068 | sc6212.ho@msa.hinet.net |
| Taiwan | |
| Chang Gung Memorial Hospital | Recruiting |
| Taoyuan, Taiwan, 333 | |
| Contact: Shu-Chuan Ho, PhD +886-3-3281200 ext 5068 | |
| Principal Investigator: | Shu-Chuan Ho, PhD | Chang Gung Memorial Hospital |
More Information
Publications:
| Responsible Party: | Ho Shu-Chuan, Assistant Professor, Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01549028 History of Changes |
| Other Study ID Numbers: | 100-2225A3 |
| Study First Received: | March 6, 2012 |
| Last Updated: | March 7, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Osteoporosis Lung Diseases, Obstructive |
Respiratory Tract Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013