Active Rehabilitation in Osteoporotic Patients (ARO)
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Details and patient eligibility
About
The main objective of this study is to target risk factors for falling, such as improved quadriceps muscle strength,balance and bone mineral density (BMD), to reduce the risk of osteoporotic fractures. Furthermore, to improve quality of life for patients with osteoporosis through an active rehabilitation program.
Sub-goals:
- To assess the effect of active rehabilitation on risk factors for osteoporotic fractures (muscle strength, bone mineral density, balance and frequency of falling) in women with low bone mineral density (BMD)(t-score<1.5) and radius fracture?
- To assess how active rehabilitation affect the quality of life of women with low bone mineral density(BMD) (t-score<1.5) and radius fracture?
Full description
Norway has one of the worlds highest rates of fractures, and osteoporosis is a major risk factor. People with established osteoporosis (low bone density including fractures) experience a lot of pain, reduced physical function and quality of life. Treatments related to osteoporotic fractures cost the Norwegian society approximately five billion NOK per year. Over the past few years there has been an increasing focus on active rehabilitation in terms of physical activity as a major factor in preventing osteoporotic fractures. It is still unknown what type of training, as well as frequency, volume and intensity of activity that is necessary to achieve effect on risk factors for osteoporotic fractures. There are only limited organized exercise offers available for these patients, and health personals are quite often unsure what recommendations they should give. In addition, the patients are often hesitant participating in physical activities due to fear of falling and the risk of new fractures. The primary objective is therefore to assess if active rehabilitation can reduce the risk for osteoporotic fractures, as well as improving quality of life for women with established osteoporosis. The patients will be recruited from The Centre of Osteoporosis at Ulleval University Hospital and will be randomised into an intervention group (n=40) and a control group (n=40). The intervention consists of active rehabilitation 3 times a week for 6 months (OsteoActive). Our model is based upon the Canadian model. The results from the project will be published in international recognized scientific papers, and as information to health personals who work with this patient group. In the long term it is desirable that the clinicians treating osteoporotic patients can recommend active rehabilitation based upon a model developed on the findings from this study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Proven low bone mineral density (t-score < 1.5) plus radius fracture
- The radius fracture must not be older than 2 years, and must be healed by start of intervention (no plaster cast)
- Postmenopausal women above 50 years
- Domicile in the Oslo region
Exclusion criteria
- Hip fracture or vertebral fracture
- History of more than 3 osteoporotic fractures in different parts of the body
- Problems/illnesses indicating that active rehabilitation is not indicated
- Physical activity (moderate and hard intensity) for more than 4 hours a week
- Does not understand Norwegian, written and spoken
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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