Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
58 participants
OBSERVATIONAL
2019-10-15
2022-01-31
Brief Summary
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This study aims to increase understanding of the link between daily exercise and risk of fracture in patients with bone metastases.
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Detailed Description
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Clinical scoring systems such as Mirel's classification, are considered predictive of pathological fracture risk. While scoring algorithms have considerable potential to inform exercise eligibility in this population, to date the applicability of such clinical measures for exercise prescription have been inadequately studied. This study will examine the relationship between habitual physical activity, captured objectively by accelerometry, and skeletal related events (pathologic fracture, spinal cord compression, necessity for radiation to bone or surgery to bone pathological fracture) in patients with metastatic disease (n=100). Clinical data including fracture risk and Skeletal Related Events (SREs), Physical Activity (PA) data and subjective measures of pain, sleep, Quality of Life (QoL) and exercise barriers and benefits will be collected at baseline. Fracture risk will be determined at baseline using Mirel's Classification, which will be assessed by a radiologist affiliated with the study research team.
With treatment advances, patients with bone metastases secondary to advanced cancer are living longer. Consequently, optimising quality-of-life is a key priority and exercise has many recognised benefits in this domain. This research will explore the association between daily activity levels and skeletal complications in patients with bone metastases, by examining methods of identifying patients who are suitable to exercise, therefore improving exercise prescription practice and exercise participation safety.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Initial systemic or local therapy post-diagnosis completed
* Commenced on bone modifying agents (BMAs)
* Provide signed and dated informed consent form
Exclusion Criteria
* Pre-existing chronic pain (persistent or recurrent pain lasting longer than 3 months) due to orthopedic, rheumatology or fibromyalgia condition
18 Years
ALL
No
Sponsors
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Irish Cancer Society
OTHER
St. James's Hospital, Ireland
OTHER
Tallaght University Hospital
OTHER
Our Lady's Hospice & Care Services, Harold's Cross
OTHER
University of Dublin, Trinity College
OTHER
Responsible Party
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Emer Guinan
Principal Investigator
Principal Investigators
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Grainne Sheill, PhD
Role: STUDY_DIRECTOR
University of Dublin, Trinity College
Lucy Balding, M.B.,MSc
Role: PRINCIPAL_INVESTIGATOR
St. James's Hospital and Our Lady's Hospice Harold's Cross
Ray McDermott, PhD
Role: PRINCIPAL_INVESTIGATOR
Tallaght University Hospital
Locations
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St. James's Hospital
Dublin, , Ireland
Countries
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Other Identifiers
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PAL17GUI
Identifier Type: -
Identifier Source: org_study_id
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