ClinicalTrials.gov
ClinicalTrials.gov Menu

Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01549028
Recruitment Status : Unknown
Verified March 2012 by Ho Shu-Chuan, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
Information provided by (Responsible Party):
Ho Shu-Chuan, Chang Gung Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
COPD, Osteoporosis Behavioral: mobile-based PR program. Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prevalence, Correlations and Effectiveness of Intervention of Osteoporosis in COPD Patients
Study Start Date : September 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Inflammatory cytokine of patients. [ Time Frame: 3 months and 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549028


Contacts
Contact: Shu-Chuan Ho, PhD +886-3281200 ext 5068 sc6212.ho@msa.hinet.net

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shu-Chuan Ho, PhD    +886-3-3281200 ext 5068      
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Shu-Chuan Ho, PhD Chang Gung Memorial Hospital

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
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Osteoporosis
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases