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

NCT05871671 | Unknown DMC

• 1 other identifier: University of Malta
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary Rehabilitation, Exercise, Physical Activity, Chronic Obstructive Pulmonary Disease, Osteoporosis, Bone Mineral Density and Bone Mineral Status

Outcome Measures

Primary Outcomes (1)

• The Changes in BMD

  BMD scores measured by DEXA Scan

  Change in BMD scores from baseline to 52weeks

Secondary Outcomes (4)

• Timed "Up and Go" Test (TUGT)

  Change in TUGT scores from baseline to 16 weeks and from 16weeks to 52weeks

• The fracture risk assessment (FRAX) tool

  Change in FRAX tool scores from baseline to 16 weeks and from 16weeks to 52weeks

• 6 minute walk test (6MWT)

  Change in 6MWT scores from baseline to 16 weeks and from 16weeks to 52weeks

• Demographics, Anthropometrics and Medical Data

  Change in Demographics, Anthropometrics and Medical Data from baseline to 16weeks and from 16weeks to 52weeks

Study Arms (2)

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.

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.

Behavioral: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation BEHAVIORAL

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.

Also known as: Respiratory Rehabilitation

Active group

Control OTHER

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.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malta: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Osteoporosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Melanie Axiak, BSc

  University of Malta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Axiak, BSc

CONTACT

79971016; melanie.axiak.14@um.edu.mt

Anabel Sciriha, PhD

CONTACT

23401573; anabel.sciriha@um.edu.mt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: May 23, 2023
• Study Start: May 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2025
• Last Updated: May 23, 2023

Record last verified: 2023-05