Chronic Obstructive Pulmonary DiseaseNCT05871671
The Effects of Pulmonary Rehabilitation on Bone Mineral Density in Patients Diagnosed With Chronic Obstructive Pulmonary Disease
A study testing Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Malta.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary Rehabilitation, Control
- Keywords
- Pulmonary Rehabilitation, Exercise, Physical Activity, Chronic Obstructive Pulmonary Disease, Osteoporosis, Bone Mineral Density and Bone Mineral Status
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationBehavioural
Also called Respiratory Rehabilitation
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Other: Control |
| Active group | Experimental | 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. Receives: Behavioral: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Changes in BMD
BMD scores measured by DEXA Scan
Measured: Change in BMD scores from baseline to 52weeks
Secondary outcomes (4)
Timed "Up and Go" Test (TUGT)
A test to measure the functional mobility level and risk for falls
Measured: Change in TUGT scores from baseline to 16 weeks and from 16weeks to 52weeks
The fracture risk assessment (FRAX) tool
A tool to estimate 10-year probability of hip fractures and major osteoporotic fractures
Measured: Change in FRAX tool scores from baseline to 16 weeks and from 16weeks to 52weeks
6 minute walk test (6MWT)
A walk test to assess the functional exercise capacity
Measured: Change in 6MWT scores from baseline to 16 weeks and from 16weeks to 52weeks
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.
Measured: Change in Demographics, Anthropometrics and Medical Data from baseline to 16weeks and from 16weeks to 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study startMay 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melanie Axiak, University of Malta
- Investigators
- Melanie Axiak, BSc, Principal investigator, University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871671
- Sponsor's protocol ID
- University of Malta
- Status last verified
- May 2023
- First submitted
- 13 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pulmonary Rehabilitation on Bone Mineral Density in Patients Diagnosed With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05871671
- Acronym / sponsor ID
- University of Malta
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary Rehabilitation, Exercise, Physical Activity, Chronic Obstructive Pulmonary Disease, Osteoporosis, Bone Mineral Density and Bone Mineral Status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: ControlThe 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. |
| Active group | Experimental | Behavioral: Pulmonary RehabilitationThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- Acute infection or exacerbation within the 3 months preceeding the start of the study
- Lack of motivation and non-adherence
- Unstable cardiovascular system
- Unstable diabetes
- Uncontrolled rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationAlso: Respiratory RehabilitationA 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. | Behavioural | Active group |
| ControlThe control group shall not receive the 16-week PR programme and the following 36-week maintenance home exercise programme until completion of the study. | Other | Control group |
Primary outcome
The Changes in BMD
Time frame: Change in BMD scores from baseline to 52weeks
BMD scores measured by DEXA Scan
4 secondary outcomes
Timed "Up and Go" Test (TUGT)
Time frame: Change in TUGT scores from baseline to 16 weeks and from 16weeks to 52weeks
The fracture risk assessment (FRAX) tool
Time frame: Change in FRAX tool scores from baseline to 16 weeks and from 16weeks to 52weeks
6 minute walk test (6MWT)
Time frame: Change in 6MWT scores from baseline to 16 weeks and from 16weeks to 52weeks
Demographics, Anthropometrics and Medical Data
Time frame: Change in Demographics, Anthropometrics and Medical Data from baseline to 16weeks and from 16weeks to 52weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Axiak, BSc principal investigator
University of Malta
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Axiak, BSc (79971016 ext. +356, melanie.axiak.14@um.edu.mt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Changes in BMD (time frame: Change in BMD scores from baseline to 52weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.