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临床试验/NCT05871671
NCT05871671尚未招募不适用

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

University of Malta0 个研究点目标入组 80 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
The Changes in BMD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The Changes in BMD

时间窗: Change in BMD scores from baseline to 52weeks

BMD scores measured by DEXA Scan

次要结局

  • 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)
  • Demographics, Anthropometrics and Medical Data(Change in Demographics, Anthropometrics and Medical Data from baseline to 16weeks and from 16weeks to 52weeks)
  • 6 minute walk test (6MWT)(Change in 6MWT scores from baseline to 16 weeks and from 16weeks to 52weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Axiak

Principal Investigator

University of Malta

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