Active Rehabilitation in Osteoporotic Patients (ARO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Norwegian School of Sport Sciences
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01357278
First received: April 21, 2010
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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?

Condition Intervention Phase
Osteoporosis
Procedure: Rehabilitation and patient education
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Quadriceps Muscle Strength [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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.

  • Quadriceps Muscle Strength [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Quadriceps Muscle Strength [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Bone Mineral Density [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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.

  • Dynamic balance [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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

  • The quality of life [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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.

  • Physical function/walking capacity [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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".

  • Physical activity level [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.

  • Anthropometric data [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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.

  • Bone Mineral Density [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Bone Mineral Density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Dynamic balance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

  • Dynamic balance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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

  • The quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • The quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Physical function/walking capacity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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".

  • Physical function/walking capacity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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".

  • Physical activity level [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.

  • Physical activity level [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.

  • Anthropometric data [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Anthropometric data [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: OsteoActive and OsteoInfo

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357278

Contacts
Contact: M A Risberg, PT, PhD +4741312776 mgri@uus.no

Locations
Norway
NAR, Department of Orthopaedics, Oslo University Hospital Recruiting
Oslo, Norway, 0407
Contact: May Arna Risberg, PT, PhD    +4741312776    mgri@uus.no   
Principal Investigator: M A Risberg, PT, PhD         
Sponsors and Collaborators
Oslo University Hospital
Norwegian School of Sport Sciences
Investigators
Study Chair: May Arna Risberg, dr philos
  More Information

No publications provided

Responsible Party: Kari Anne Hakestad/RN, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01357278     History of Changes
Other Study ID Numbers: OsteoActive
Study First Received: April 21, 2010
Last Updated: May 18, 2011
Health Authority: Norway: Ethics Committee
Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
osteoporosis
exercise
intervention
rehabilitation
bone mineral density
muscle strength

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 21, 2014