Clinical trial NCT05871671: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary Rehabilitation, Exercise, Physical Activity, Chronic Obstructive Pulmonary Disease, Osteoporosis, Bone Mineral Density and Bone Mineral Status
Lead sponsor: University of Malta
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Changes in BMD
timeFrame: Change in BMD scores from baseline to 52weeks
Secondary outcomes:
measure: Timed "Up and Go" Test (TUGT)
timeFrame: Change in TUGT scores from baseline to 16 weeks and from 16weeks to 52weeks
measure: The fracture risk assessment (FRAX) tool
timeFrame: Change in FRAX tool scores from baseline to 16 weeks and from 16weeks to 52weeks
measure: 6 minute walk test (6MWT)
timeFrame: Change in 6MWT scores from baseline to 16 weeks and from 16weeks to 52weeks
measure: Demographics, Anthropometrics and Medical Data
timeFrame: Change in Demographics, Anthropometrics and Medical Data from baseline to 16weeks and from 16weeks to 52weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Malta
name: Melanie Axiak, BSc
role: PRINCIPAL_INVESTIGATOR
References: