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Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

COPD,, Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
mobile-based PR program.
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD,

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile-based PR program.

Arm Description

Home based mobile PR program for 3 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 6, 2012
Last Updated
March 7, 2012
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01549028
Brief Title
Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
The Prevalence, Correlations and Effectiveness of Intervention of Osteoporosis in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD,, Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile-based PR program.
Arm Type
Experimental
Arm Description
Home based mobile PR program for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
mobile-based PR program.
Intervention Description
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 Measure Information:
Title
exercise tolerance.
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Inflammatory cytokine of patients.
Description
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.
Time Frame
3 months and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Chuan Ho, PhD
Phone
+886-3281200
Ext
5068
Email
sc6212.ho@msa.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Chuan Ho, PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Chuan Ho, PhD
Phone
+886-3-3281200
Ext
5068

12. IPD Sharing Statement

Citations:
PubMed Identifier
20562122
Citation
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.
Results Reference
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PubMed Identifier
18508824
Citation
Liu 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.
Results Reference
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Learn more about this trial

Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD)

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