Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
The Effects of Pulmonary Rehabilitation on Bone Mineral Density in Patients Diagnosed With Chronic Obstructive Pulmonary Disease
Exercise has been reported to lead to improvements in Bone Mineral Density (BMD), however studies looking into the effects of exercise on BMD in Chronic Obstructive Pulmonary Disease (COPD) patients are still very limited. In view of this, the aims of such a study are to identify whether a 16-week Pulmonary Rehabilitation programme leads to improvements in BMD in patients with osteopenia and osteoporosis diagnosed with stable COPD, something which is warranted to reduce the risk of fractures and their related adverse consequences in these patients.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | September 2025 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Confirmed diagnosis of COPD by Spirometry - Stable COPD confirmed by lack of an exacerbation within the 3 months preceeding the start of the study - Confirmed diagnosis of osteopenia or osteoporosis by DEXA scan which would have been carried out at some point in the previous 12 months - Due for a DEXA scan in the timeframe when the researcher shall be carrying out her data collection. This will ensure that no patients shall be receiving any exposures that were not part of their routine medical management - Optimal medical management - SpO2 >92% at rest - Motivated and committed - Suitable cognitive and communicative ability Exclusion Criteria: - Acute infection or exacerbation within the 3 months preceeding the start of the study - Lack of motivation and non-adherence - Unstable cardiovascular system - Myocardial Infarction within last 6 weeks - Uncontrolled hypertension - Unstable angina - Aortic stenosis - Acute Left Ventricular Failure - Uncontrolled cardiac arrhythmias - Unstable diabetes - Uncontrolled rheumatoid arthritis - Severe orthopaedic or neuromuscular conditions - Significant cognitive or psychiatric impairment which interfere with the PR programme |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Malta |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Changes in BMD | BMD scores measured by DEXA Scan | Change in BMD scores from baseline to 52weeks | |
Secondary | Timed "Up and Go" Test (TUGT) | A test to measure the functional mobility level and risk for falls | Change in TUGT scores from baseline to 16 weeks and from 16weeks to 52weeks | |
Secondary | The fracture risk assessment (FRAX) tool | A tool to estimate 10-year probability of hip fractures and major osteoporotic fractures | Change in FRAX tool scores from baseline to 16 weeks and from 16weeks to 52weeks | |
Secondary | 6 minute walk test (6MWT) | A walk test to assess the functional exercise capacity | Change in 6MWT scores from baseline to 16 weeks and from 16weeks to 52weeks | |
Secondary | Demographics, Anthropometrics and Medical Data | demographic and anthropometric details and individual patient factors known to affect bone metabolism including; age, gender, smoking status and any concurrent prescribed medications and supplements, shall be gathered directly from all participants. The patients' body weight and height and the Body Mass Index shall be then calculated. | Change in Demographics, Anthropometrics and Medical Data from baseline to 16weeks and from 16weeks to 52weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|