Active Rehabilitation in Osteoporotic Patients

Osteoporosis Clinical Trial

— ARO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357278
• Other study ID #: OsteoActive
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: October 14, 2015
• Start date: January 2007
• Est. completion date: May 2011

Study information

• Verified date: October 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics CommitteeNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Procedure:
• Rehabilitation and patient education
Supervised rehabilitation consists of exercises for strength, balance and coordination twice weekly, and a home-training programme once weekly. Patient education will be offered every eight week.

Locations

Country	Name	City	State
Norway	NAR, Department of Orthopaedics, Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian School of Sport Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps Muscle Strength	Quadriceps muscle strength will be examined using isokinetic muscular strength tests on a Biodex machine (Biodex System 3 Pro, USA) and measured as peak torque (N-M) and total work of 60 and 180 degrees per second.	Baseline	Yes
Primary	Quadriceps Muscle Strength	Quadriceps muscle strength will be examined using isokinetic muscular strength tests on a Biodex machine (Biodex System 3 Pro, USA) and measured as peak torque (N-M) and total work of 60 and 180 degrees per second.	6 months	Yes
Primary	Quadriceps Muscle Strength	Quadriceps muscle strength will be examined using isokinetic muscular strength tests on a Biodex machine (Biodex System 3 Pro, USA) and measured as peak torque (N-M) and total work of 60 and 180 degrees per second.	12 months	Yes
Secondary	Bone Mineral Density	Bone Mineral Density will be measured by means of "Double X-ray Absorptiometry" (DXA, Lunar, Prodigy). DXA is a measuring technique using x-rays with very low ray exposure. The method is exact, reliable, and the measuring time is briefer than for any other way to measure BMD. The scanned areas will be hip, femur neck and trochanter, arms, and lumbar spine.	Baseline	Yes
Secondary	Dynamic balance	Dynamic balance will be evaluated with Four Square Step Test (FSST).FSST is a dynamic standing balance test used to test balance in both multiple fallers (2 or more falls within the last 6 months) and non-multiple fallers (fewer than 2 falls within the last 6 months. Two FSST are completed using the best score of the two trials	Baseline	Yes
Secondary	The quality of life	The quality of life will be evaluated by means of SF-36. SF-36 measures the patient's own health related quality of life. The instrument is divided into eight sub-scales (physical function, role limitations, physical, bodily pain, general health, vitality, social function, role limitations, emotional, and mental health). The SF-36 is scored to a 0-100 scale for each sub-scale, the higher the score the better the health status.	Baseline	Yes
Secondary	Physical function/walking capacity	Physical function/walking capacity will be evaluated using the 6 minutes walk test. This test has been validated for measuring functional status in elderly people. Following the 6 minutes walk test, the subjects will answer the following question on "Borgsskala" for measuring how exhausting they experienced the walking test, "on a scale from 6-20, where 6 indicates very easy and 20 indicates very exhausting".	Baseline	Yes
Secondary	Physical activity level	Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.	Baseline	Yes
Secondary	Anthropometric data	Anthropometric data such as height, weight, absolute and percentage fat, plus fat-free mass, will be measured by means of weight- and height scales and DXA measurements.	Baseline	Yes
Secondary	Bone Mineral Density	Bone Mineral Density will be measured by means of "Double X-ray Absorptiometry" (DXA, Lunar, Prodigy). DXA is a measuring technique using x-rays with very low ray exposure. The method is exact, reliable, and the measuring time is briefer than for any other way to measure BMD. The scanned areas will be hip, femur neck and trochanter, arms, and lumbar spine.	6 months	Yes
Secondary	Bone Mineral Density	Bone Mineral Density will be measured by means of "Double X-ray Absorptiometry" (DXA, Lunar, Prodigy). DXA is a measuring technique using x-rays with very low ray exposure. The method is exact, reliable, and the measuring time is briefer than for any other way to measure BMD. The scanned areas will be hip, femur neck and trochanter, arms, and lumbar spine.	12 months	Yes
Secondary	Dynamic balance	Dynamic balance will be evaluated with Four Square Step Test (FSST).FSST is a dynamic standing balance test used to test balance in both multiple fallers (2 or more falls within the last 6 months) and non-multiple fallers (fewer than 2 falls within the last 6 months. Two FSST are completed using the best score of the two trials	6 months	Yes
Secondary	Dynamic balance	Dynamic balance will be evaluated with Four Square Step Test (FSST).FSST is a dynamic standing balance test used to test balance in both multiple fallers (2 or more falls within the last 6 months) and non-multiple fallers (fewer than 2 falls within the last 6 months. Two FSST are completed using the best score of the two trials	12 months	Yes
Secondary	The quality of life	The quality of life will be evaluated by means of SF-36. SF-36 measures the patient's own health related quality of life. The instrument is divided into eight sub-scales (physical function, role limitations, physical, bodily pain, general health, vitality, social function, role limitations, emotional, and mental health). The SF-36 is scored to a 0-100 scale for each sub-scale, the higher the score the better the health status.	6 months	Yes
Secondary	The quality of life	The quality of life will be evaluated by means of SF-36. SF-36 measures the patient's own health related quality of life. The instrument is divided into eight sub-scales (physical function, role limitations, physical, bodily pain, general health, vitality, social function, role limitations, emotional, and mental health). The SF-36 is scored to a 0-100 scale for each sub-scale, the higher the score the better the health status.	12 months	Yes
Secondary	Physical function/walking capacity	Physical function/walking capacity will be evaluated using the 6 minutes walk test. This test has been validated for measuring functional status in elderly people. Following the 6 minutes walk test, the subjects will answer the following question on "Borgsskala" for measuring how exhausting they experienced the walking test, "on a scale from 6-20, where 6 indicates very easy and 20 indicates very exhausting".	6 months	Yes
Secondary	Physical function/walking capacity	Physical function/walking capacity will be evaluated using the 6 minutes walk test. This test has been validated for measuring functional status in elderly people. Following the 6 minutes walk test, the subjects will answer the following question on "Borgsskala" for measuring how exhausting they experienced the walking test, "on a scale from 6-20, where 6 indicates very easy and 20 indicates very exhausting".	12 months	Yes
Secondary	Physical activity level	Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.	6 months	Yes
Secondary	Physical activity level	Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.	12 months	Yes
Secondary	Anthropometric data	Anthropometric data such as height, weight, absolute and percentage fat, plus fat-free mass, will be measured by means of weight- and height scales and DXA measurements.	6 months	Yes
Secondary	Anthropometric data	Anthropometric data such as height, weight, absolute and percentage fat, plus fat-free mass, will be measured by means of weight- and height scales and DXA measurements.	12 months	Yes