OsteoporosisNCT01120197
Study of Effect of Exercise With Osteoporosis and Vertebral Fracture
A study testing Exercise group in people with Osteoporosis and Vertebral Fracture, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
The aim of this randomized controlled trial is to evaluate the effectiveness for health-related quality of life (HRQOL) of a 3-month course of exercises for a group of postmenopausal women with osteoporosis who has at least one vertebral fracture versus a control group (undertaking their usual activities). Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteoporosis, Vertebral Fracture
- What is being tested?
- Exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteNorway
- Study dates
- May 2005to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women
- living at home
- ambulatory
- aged 60 or more
- clinical diagnosis of osteoporosis
- a history of vertebral fracture
Who cannot join
- recent vertebral fractures
- unable to complete the questionnaires
- major cognitive impairment (MMSE) ( MMS < 23 )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Effect of Exercise on Health-related Quality of Life, Mobility and Balance in Osteoporotic Women With a History of Vertebral Fracture.
The aim of this randomized controlled trial is to evaluate the effectiveness for health-related quality of life (HRQOL) of a 3-month course of exercises for a group of postmenopausal women with osteoporosis who has at least one vertebral fracture versus a control group (undertaking their usual activities). The course of exercises is devised in accordance with methods recommended in "Rehabilitation treatment guidelines in postmenopausal and senile osteoporosis".
Read the detailed description
Public health policies in most European countries are concerned with how to keep older people living independently with a qualitatively good life in the community as long as possible. Apart from its personal and human cost, osteoporosis is a major public health problem, which has an enormous social and economic impact. Osteoporosis(OP) is a common condition among older people,and a non-fatal condition that leads more to changes in the quality of life than to change in the length of life. Osteoporosis is a skeletal disorder characterized by decreased bone mass. The World Health Organization (WHO) Study Group on Osteoporosis has defined osteoporosis as "a hip BMD level of more than 2.5 SDs below the mean BMD for young, white, adult women". Using the WHO definition, approximately 30% of postmenopausal women have osteoporosis.
The most common consequences of osteoporosis are fractures. Furthermore the most common conditions associated with osteoporosis are back pain, limitations in physical functioning, and psychosocial impairment. Thus, the purpose of this study is to record the effect of the programme on mobility, balance, the disease-specific and generic health-related quality of life for women with osteoporosis and a history of vertebral fractures. The programme consist of a three-hour educational session and a three-month course of exercises in accordance with guidelines for women with an increased risk of falls and postmenopausal osteoporotic women with a history of fractures.
Our hypothesis that a three-month course of exercises and a three-hour lesson on how to cope with osteoporosis will have a significantly positive effect on the generic and disease-specific quality of life, as well as the balance and mobility, of elderly (≥60 years) women with postmenopausal osteoporosis and a history of vertebral fractures, both 3 months after the intervention and after one year.
The sample would be recruited from the Osteoporosis Outpatient clinic at the Ostfold Hospital, Norway and they their body mineral density (BMD) has been measured using Dual-Energy X-Ray Absorptiometry (DXA). The design of the study is a randomized controlled trial and the sample would be randomized to an intervention group or a control group.
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures.
A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
- Conditions
- Osteoporosis, Vertebral Fracture
- Being tested
- Exercise group, Control Group
- Keywords
- randomized controlled trial, osteoporosis, moderate-intensity circuit exercises, balance, health-related quality of life
- Medical subject headings
- Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupOther
Weekly exercises
Control GroupOther
No Intervention, control group only
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Exercise group with intervention
Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions). Receives: Other: Exercise group |
| Control Group | Other | Control group with no intervention
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. The control group is followed for the same duration as the intervention group. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Used to Walk 20 m at Maximal Speed.
Times (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded
Measured: At baseline, 3 and 12 months after the baseline
Secondary outcomes (5)
Timed Up & Go Test (TUG)
The subject will be instructed to rise from a chair with a seat height of 43 cm, walk 3 m, turn around, return and sit down again, wearing ordinary footwear and use customary walking aids if necessary.
Measured: At baseline, 3 and 12 months after the baseline.
Functional Reach
The maximum distance in centimetres that can be reached forward in a standing position while maintaining a fixed base of support. Subjects will be instructed to stand sideways against a wall in a natural position and stretch one arm forward level with the shoulder. The position of the third metacarpophalangeal (MCP) joint was taken as the zero point. With the body tilted forward as far as possible, the subjects continued to stretch the arm parallel to the ground.
Amount of cm indicate better balance.
Measured: At baseline, 3 and 12 months after the baseline
QUALEFFO 41
Quality of Life Questionnaire issued by the European Foundation for Osteoporosis (QUALEFFO-41), is a disease-specific questionnaire to be used by patients with vertebral fractures attributed to osteoporosis. QUALEFFO-41 is self-administered and contains questions in five domains: pain, ability to perform physical functions, social functioning, general health perception and mental performance. These five domains can be evaluated individually or be represented in a total score. All scores in all the domains are expressed in values ranging from 0-100, where 0 represents the best and 100 the worst. The total QALEFFO score is calculated as a sum of all answers to items and then linearly transformed on the scale 0-100.
High scores indicate poor quality of life.
Measured: At baseline, 3 and 12 months after the baseline
General Health Questionnaire 20 (GHQ20).
GHQ-20 is a generic instrument and registers distress and psychopathology. GHQ-20 is self-administered and the answers to each item may be treated as a "Likert Scale" and have weights assigned to each position (0-1-2-3) where 0 is no distress, and 3 is severe distress. This gives a possible range for the total GHQ-20 score of 0-60. Higher scores indicating poor qol.
Measured: At baseline, 3 and 12 months after baseline
Falls-Efficacy Scale-International
A 16- item self report or interview- based questionnaire assessing the fear of falling during basic and more demanding activities of daily living (Yardley et al. 2005). Each item is scored on a four point scale. Minimun score indicating low concern about falling is 16. The maximun score indication high concern about falling is 64.
Measured: Baseline, 3 months follow-up, 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2005
- Primary completionJan 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Astrid Bergland, Professor, Study director, Faculty of Health Science, University of Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120197
- Sponsor's protocol ID
- 301.0
- Status last verified
- Sep 2016
- First submitted
- 6 May 2010
- Last updated
- 28 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effect of Exercise on Health-related Quality of Life, Mobility and Balance in Osteoporotic Women With a History of Vertebral Fracture.
- ClinicalTrials.gov ID
- NCT01120197
- Acronym / sponsor ID
- 301.0
- Conditions
- Osteoporosis, Vertebral Fracture
- Keywords
- randomized controlled trial, osteoporosis, moderate-intensity circuit exercises, balance, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- May 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 30 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled trial is to evaluate the effectiveness for health-related quality of life (HRQOL) of a 3-month course of exercises for a group of postmenopausal women with osteoporosis who has at least one vertebral fracture versus a control group (undertaking their usual activities). The course of exercises is devised in accordance with methods recommended in "Rehabilitation treatment guidelines in postmenopausal and senile osteoporosis".
Detailed description
Public health policies in most European countries are concerned with how to keep older people living independently with a qualitatively good life in the community as long as possible. Apart from its personal and human cost, osteoporosis is a major public health problem, which has an enormous social and economic impact. Osteoporosis(OP) is a common condition among older people,and a non-fatal condition that leads more to changes in the quality of life than to change in the length of life. Osteoporosis is a skeletal disorder characterized by decreased bone mass. The World Health Organization (WHO) Study Group on Osteoporosis has defined osteoporosis as "a hip BMD level of more than 2.5 SDs below the mean BMD for young, white, adult women". Using the WHO definition, approximately 30% of postmenopausal women have osteoporosis.
The most common consequences of osteoporosis are fractures. Furthermore the most common conditions associated with osteoporosis are back pain, limitations in physical functioning, and psychosocial impairment. Thus, the purpose of this study is to record the effect of the programme on mobility, balance, the disease-specific and generic health-related quality of life for women with osteoporosis and a history of vertebral fractures. The programme consist of a three-hour educational session and a three-month course of exercises in accordance with guidelines for women with an increased risk of falls and postmenopausal osteoporotic women with a history of fractures.
Our hypothesis that a three-month course of exercises and a three-hour lesson on how to cope with osteoporosis will have a significantly positive effect on the generic and disease-specific quality of life, as well as the balance and mobility, of elderly (≥60 years) women with postmenopausal osteoporosis and a history of vertebral fractures, both 3 months after the intervention and after one year.
The sample would be recruited from the Osteoporosis Outpatient clinic at the Ostfold Hospital, Norway and they their body mineral density (BMD) has been measured using Dual-Energy X-Ray Absorptiometry (DXA). The design of the study is a randomized controlled trial and the sample would be randomized to an intervention group or a control group.
Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures.
A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise groupExercise group with intervention Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions). |
| Control Group | Other | Other: Control GroupControl group with no intervention Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. The control group is followed for the same duration as the intervention group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women
- living at home
- ambulatory
- aged 60 or more
- clinical diagnosis of osteoporosis
Key exclusion criteria (3 listed)
- recent vertebral fractures
- unable to complete the questionnaires
- major cognitive impairment (MMSE) ( MMS < 23 )
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 |
|---|---|---|
| Exercise groupWeekly exercises | Other | Exercise group |
| Control GroupNo Intervention, control group only | Other | Control Group |
Primary outcome
Time Used to Walk 20 m at Maximal Speed.
Time frame: At baseline, 3 and 12 months after the baseline
Times (measured in seconds) used walking at maximum speed for 20m indoors. No acceleration or deceleration phase used. The type of walking aids used during the test will be recorded. The participants walk as fast as possible wearing their ordinary shoes. The test perform once, the time measured with a stopwatch and the time used on 20 m will be recorded
5 secondary outcomes
Timed Up & Go Test (TUG)
Time frame: At baseline, 3 and 12 months after the baseline.
Functional Reach
Time frame: At baseline, 3 and 12 months after the baseline
QUALEFFO 41
Time frame: At baseline, 3 and 12 months after the baseline
General Health Questionnaire 20 (GHQ20).
Time frame: At baseline, 3 and 12 months after baseline
Falls-Efficacy Scale-International
Time frame: Baseline, 3 months follow-up, 12 months follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Astrid Bergland, Professor study director
Faculty of Health Science, University of Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Osteoporosis and Vertebral Fracture, run by Ostfold Hospital Trust 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 6 inclusion and 3 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 28 Oct 2016. 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?
Yes. Results are posted in the registry (first posted 30 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Used to Walk 20 m at Maximal Speed. (time frame: At baseline, 3 and 12 months after the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2016.