OsteoporosisARONCT01357278
Active Rehabilitation in Osteoporotic Patients
A study testing Rehabilitation and patient education in people with Osteoporosis, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Rehabilitation and patient education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Norway1 site
NAR, Department of Orthopaedics, Oslo University Hospital
Oslo, 0407
About this study
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
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?
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Rehabilitation and patient education
- Keywords
- osteoporosis, exercise, intervention, rehabilitation, bone mineral density, muscle strength
- Medical subject headings
- Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation and patient educationProcedure or surgery
Also called OsteoActive and OsteoInfo
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation and patient education | Experimental | 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. Receives: Procedure: Rehabilitation and patient education |
| Patient education | No intervention | Patient education will be offered every eight week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (18)
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.
Measured: 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
Measured: 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.
Measured: 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".
Measured: Baseline
Physical activity level
Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 12 months
Physical activity level
Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.
Measured: 6 months
Physical activity level
Physical activity level will be registered using the validated self-reported level of physical activity for elderly, PASE.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startJan 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Kari Anne Hakestad, Oslo University Hospital
- Investigators
- May Arna Risberg, dr philos, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357278
- Sponsor's protocol ID
- OsteoActive
- Acronym
- ARO
- Status last verified
- Oct 2015
- First submitted
- 21 Apr 2010
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26578370Hakestad 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.
PubMed 25579693
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01357278
- Acronym / sponsor ID
- ARO / OsteoActive
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, exercise, intervention, rehabilitation, bone mineral density, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- Jan 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation and patient education | Experimental | Procedure: Rehabilitation and patient educationSupervised 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. |
| Patient education | No intervention | –Patient education will be offered every eight week. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation and patient educationAlso: OsteoActive and OsteoInfoSupervised 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 or surgery | Rehabilitation and patient education |
Primary outcome
Quadriceps Muscle Strength
Time frame: Baseline
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
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
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.
18 secondary outcomes
Bone Mineral Density
Time frame: Baseline
Dynamic balance
Time frame: Baseline
The quality of life
Time frame: Baseline
Physical function/walking capacity
Time frame: Baseline
Physical activity level
Time frame: Baseline
Anthropometric data
Time frame: Baseline
Bone Mineral Density
Time frame: 6 months
Bone Mineral Density
Time frame: 12 months
Dynamic balance
Time frame: 6 months
Dynamic balance
Time frame: 12 months
The quality of life
Time frame: 6 months
The quality of life
Time frame: 12 months
Physical function/walking capacity
Time frame: 6 months
Physical function/walking capacity
Time frame: 12 months
Physical activity level
Time frame: 6 months
Physical activity level
Time frame: 12 months
Anthropometric data
Time frame: 6 months
Anthropometric data
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Derived from this study: PubMed 26578370Hakestad 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.
- Derived from this study: PubMed 25579693Hakestad 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.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Arna Risberg, dr philos study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation and patient education in people with Osteoporosis, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Strength (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357278, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.