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The Effects of Pulmonary Rehabilitation on Bone Mineral Density in Patients Diagnosed With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Control
Sponsored by
University of Malta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary Rehabilitation, Exercise, Physical Activity, Chronic Obstructive Pulmonary Disease, Osteoporosis, Bone Mineral Density and Bone Mineral Status

Eligibility Criteria

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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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Active group

    Arm Description

    The control group shall consist of a minimum of 40 patients with a confirmed diagnosis of COPD and osteoporosis or osteopenia. This group which shall consist of patients who do not wish to participate in Pulmonary Rehabilitation but show the wish to form part of this study, or participants who are on the waiting list to be enrolled into the Rehabilitation classes, shall act as a control for the study and therefore not undergo PR and the following maintenance home exercise programme until completion of the study. All patients were medically stable and referred by their caring respiratory consultant.

    The active group shall consist of a minimum of 40 patients with a confirmed diagnosis of COPD and osteoporosis or osteopenia. All patients shall receive a 16-week twice weekly PR programme which shall be followed by a 36-week maintenance home exercise programme. All patients were medically stable and referred by their caring respiratory consultant.

    Outcomes

    Primary Outcome Measures

    The Changes in BMD
    BMD scores measured by DEXA Scan

    Secondary Outcome Measures

    Timed "Up and Go" Test (TUGT)
    A test to measure the functional mobility level and risk for falls
    The fracture risk assessment (FRAX) tool
    A tool to estimate 10-year probability of hip fractures and major osteoporotic fractures
    6 minute walk test (6MWT)
    A walk test to assess the functional exercise capacity
    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.

    Full Information

    First Posted
    May 13, 2023
    Last Updated
    May 13, 2023
    Sponsor
    University of Malta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05871671
    Brief Title
    The Effects of Pulmonary Rehabilitation on Bone Mineral Density in Patients Diagnosed With Chronic Obstructive Pulmonary Disease
    Official Title
    The Effects of Pulmonary Rehabilitation on Bone Mineral Density in Patients Diagnosed With Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malta

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Patients suffering from Chronic Obstructive Pulmonary Disease (COPD) are reported to have a high prevalence rate and increased risk of osteopenia and osteoporosis especially due to the intake of corticosteroids, a factor which increases their risks of falls and likelihood of fractures. Considering the enormous impact of such fractures on COPD patients, prophylactic measures are warranted to prevent further loss of BMD to reduce their risk of fractures and their related adverse consequences. Exercise has been reported to lead to improvements in BMD. Evidence regarding the effects of such an intervention on BMD in COPD patients is still very limited. In view of this, the aims of such a study are to identify whether a 16-week Pulmonary Rehabilitation (PR) programme leads to improvements in BMD in patients with osteopenia and osteoporosis diagnosed with stable COPD. A minimum of 80 patients shall be allocated to either the active group or the control group by the intermediary. The active group shall receive a PR Programme delivered twice weekly for a period of 16 weeks which shall be followed by a maintenance home exercise programme for a period of 36 weeks. The other group which shall consist of patients who do not wish to participate in Pulmonary Rehabilitation but show the wish to form part of this study, or participants who are on the waiting list to be enrolled into the Rehabilitation classes, shall act as a control for the study and therefore not undergo PR and the following maintenance home exercise programme until completion of the study. As part of the assessment, at baseline (week 0), 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. Each participant's last DEXA scan measurement shall be retrieved from the Picture Archiving and Communication System (PACS) through the intermediary. All participants shall also have their functional mobility level and fall risk assessed using the Timed "Up and Go" test (TUGT). Estimated 10-year probability of hip fractures and major osteoporotic fractures shall be predicted using WHO web-based fracture risk assessment (FRAX) tool. All participants shall also have their functional exercise capacity assessed using the Six-Minute Walk Test (6MWT). At week 16 and at week 52 all patients shall be reassessed as baseline, except for the measurement of the bone mineral density which shall be taken using DEXA scan only at week 52 and shall be retrieved from the PACS through the intermediary for the active and control group subjects and shall be required per protocol.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    Pulmonary Rehabilitation, Exercise, Physical Activity, Chronic Obstructive Pulmonary Disease, Osteoporosis, Bone Mineral Density and Bone Mineral Status

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The control group shall consist of a minimum of 40 patients with a confirmed diagnosis of COPD and osteoporosis or osteopenia. This group which shall consist of patients who do not wish to participate in Pulmonary Rehabilitation but show the wish to form part of this study, or participants who are on the waiting list to be enrolled into the Rehabilitation classes, shall act as a control for the study and therefore not undergo PR and the following maintenance home exercise programme until completion of the study. All patients were medically stable and referred by their caring respiratory consultant.
    Arm Title
    Active group
    Arm Type
    Experimental
    Arm Description
    The active group shall consist of a minimum of 40 patients with a confirmed diagnosis of COPD and osteoporosis or osteopenia. All patients shall receive a 16-week twice weekly PR programme which shall be followed by a 36-week maintenance home exercise programme. All patients were medically stable and referred by their caring respiratory consultant.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pulmonary Rehabilitation
    Other Intervention Name(s)
    Respiratory Rehabilitation
    Intervention Description
    A 16-week PR programme shall be delivered twice weekly to the active group. This shall be followed by a 36-week maintenance home exercise programme which shall be monitored every 4 weeks via a phone call from the researcher herself for 36 weeks. The subjects shall self-document their adherence to the home exercise programme on a diary which shall be returned to the researcher at week 52.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    The control group shall not receive the 16-week PR programme and the following 36-week maintenance home exercise programme until completion of the study.
    Primary Outcome Measure Information:
    Title
    The Changes in BMD
    Description
    BMD scores measured by DEXA Scan
    Time Frame
    Change in BMD scores from baseline to 52weeks
    Secondary Outcome Measure Information:
    Title
    Timed "Up and Go" Test (TUGT)
    Description
    A test to measure the functional mobility level and risk for falls
    Time Frame
    Change in TUGT scores from baseline to 16 weeks and from 16weeks to 52weeks
    Title
    The fracture risk assessment (FRAX) tool
    Description
    A tool to estimate 10-year probability of hip fractures and major osteoporotic fractures
    Time Frame
    Change in FRAX tool scores from baseline to 16 weeks and from 16weeks to 52weeks
    Title
    6 minute walk test (6MWT)
    Description
    A walk test to assess the functional exercise capacity
    Time Frame
    Change in 6MWT scores from baseline to 16 weeks and from 16weeks to 52weeks
    Title
    Demographics, Anthropometrics and Medical Data
    Description
    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.
    Time Frame
    Change in Demographics, Anthropometrics and Medical Data from baseline to 16weeks and from 16weeks to 52weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Melanie Axiak, BSc
    Phone
    79971016
    Ext
    +356
    Email
    melanie.axiak.14@um.edu.mt
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anabel Sciriha, PhD
    Phone
    23401573
    Ext
    +356
    Email
    anabel.sciriha@um.edu.mt
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melanie Axiak, BSc
    Organizational Affiliation
    University of Malta
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Pulmonary Rehabilitation on Bone Mineral Density in Patients Diagnosed With Chronic Obstructive Pulmonary Disease

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