Clinical trial NCT01357278: Active Rehabilitation in Osteoporotic Patients
Official title: Effect of Active Rehabilitation on Risk Factors for Fall, Bone Mineral Density, and the Quality of Life in Osteoporotic Patients. A Randomized, Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
exercise
intervention
rehabilitation
bone mineral density
muscle strength
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2011-05-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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:

1. 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?
2. 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?

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quadriceps Muscle Strength
timeFrame: Baseline
measure: Quadriceps Muscle Strength
timeFrame: 6 months
measure: Quadriceps Muscle Strength
timeFrame: 12 months
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: Baseline
measure: Dynamic balance
timeFrame: Baseline
measure: The quality of life
timeFrame: Baseline
measure: Physical function/walking capacity
timeFrame: Baseline
measure: Physical activity level
timeFrame: Baseline
measure: Anthropometric data
timeFrame: Baseline
measure: Bone Mineral Density
timeFrame: 6 months
measure: Bone Mineral Density
timeFrame: 12 months
measure: Dynamic balance
timeFrame: 6 months
measure: Dynamic balance
timeFrame: 12 months
measure: The quality of life
timeFrame: 6 months
measure: The quality of life
timeFrame: 12 months
measure: Physical function/walking capacity
timeFrame: 6 months
measure: Physical function/walking capacity
timeFrame: 12 months
measure: Physical activity level
timeFrame: 6 months
measure: Physical activity level
timeFrame: 12 months
measure: Anthropometric data
timeFrame: 6 months
measure: Anthropometric data
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: NAR, Department of Orthopaedics, Oslo University Hospital
Study officials:
name: May Arna Risberg, dr philos
role: STUDY_CHAIR
References:
citation: Hakestad KA, Torstveit MK, Nordsletten L, Risberg MA. Effect of exercises with weight vests and a patient education programme for women with osteopenia and a healed wrist fracture: a randomized, controlled trial of the OsteoACTIVE programme. BMC Musculoskelet Disord. 2015 Nov 14;16:352. doi: 10.1186/s12891-015-0811-z.
citation: Hakestad KA, Torstveit MK, Nordsletten L, Axelsson AC, Risberg MA. Exercises including weight vests and a patient education program for women with osteopenia: a feasibility study of the OsteoACTIVE rehabilitation program. J Orthop Sports Phys Ther. 2015 Feb;45(2):97-105, C1-4. doi: 10.2519/jospt.2015.4842. Epub 2015 Jan 10.