Active Rehabilitation in Osteoporotic Patients (ARO)

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

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?

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Procedure: Rehabilitation and patient education

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • NAR, Department of Orthopaedics, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: OsteoActive and OsteoInfo
No Intervention: Patient education; Patient education will be offered every eight week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Physical activity level	Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.	Baseline
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
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
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
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
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
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
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
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
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
Physical activity level	Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.	6 months
Physical activity level	Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.	12 months
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
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian School of Sport Sciences
• Investigators: Study Chair: May Arna Risberg, dr philos

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 20, 2011

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; muscle strength; osteoporosis; intervention; bone mineral density
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: OsteoActive