Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Ho Shu-Chuan, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01549028
First received: March 6, 2012
Last updated: March 7, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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:
Osteoporosis
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014