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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Control; Behavioral: Pulmonary Rehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Axiak, BSc; Phone Number: +356 79971016; Email: melanie.axiak.14@um.edu.mt
• Study Contact Backup: Name: Anabel Sciriha, PhD; Phone Number: +356 23401573; Email: anabel.sciriha@um.edu.mt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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.	Other: Control; 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.
Experimental: Active group; 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.	Behavioral: Pulmonary 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.; Other Names: Respiratory Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Changes in BMD	BMD scores measured by DEXA Scan	Change in BMD scores from baseline to 52weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Malta
• Investigators: Principal Investigator: Melanie Axiak, BSc, University of Malta

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: May 13, 2023
• First Submitted That Met QC Criteria: May 13, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation, Exercise, Physical Activity, Chronic Obstructive Pulmonary Disease, Osteoporosis, Bone Mineral Density and Bone Mineral Status
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: University of Malta

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No