Bone Mineral DensityNCT00655577
Exercise and Prevention of Hip Fractures
A study testing Exercise in people with Bone Mineral Density and Strength, run by University of Oulu at 1 site in Finland.
Trial summary
The significance of this population-based study is in producing new information for planning interventions and rehabilitation programs for the elderly, planning education of health care personnel and planning national health education programs for different age groups. Read more about this study
- Who is it for?
- Ages 71 to 74 years, women only
- Conditions the study is for
- Bone Mineral Density, Strength, Balance
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFinland
- Study dates
- Aug 1998to Dec 2004
- 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 71 to 74 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- female gender
- born during 1924-1927 and living in Oulu, Finland in 1997
- distal radius BMD value of more than 2 SD below the reference value
- hip BMD value of more than 2SD below the reference value
Who cannot join
- use of walking aid device other than a stick
- bilateral hip joint replacement
- unstable chronic illness
- malignancy
- medication known to affect bone density
- severe cognitive impairment
- involvement in other interventions
Trial locations and contacts
1 site in 1 country.
Finland1 site
Oulu Deaconess Institute, Department of Sports Medicine
Oulu, 90100
About this study
Official title: Role of Exercise in Prevention of Osteoporotic Fractures in Elderly Women
The significance of this population-based study is in producing new information for planning interventions and rehabilitation programs for the elderly, planning education of health care personnel and planning national health education programs for different age groups.
The study consists of an epidemiological cross-sectional study and a randomized controlled intervention study. The study population consisted of all the 1689 home-dwelling women born during 1924-1927 residing in Oulu, Northern Finland, who were asked to a screening visit including bone mineral density (BMD) measurement of the distal radius in 1997. 1222 women attended the clinic and were afterwards mailed a postal questionnaire focusing on lifelong risk factors for osteoporosis, e.g. the amount of physical activity at work and during leisure time, daily intake of calcium and use of alcohol and cigarettes. Those with BMD value more than 20% lower than the reference value, underwent a densitometry of the hip. All women with femoral neck BMD more than 20% below the reference value (n=160) were randomly selected to either exercise (n=84) or control (n=76) group. At baseline and after that annually during the 30-month intervention, balance, muscle strength, aerobic capacity, walking speed, cognitive functions and mood are measured from all the participants. Hip BMD will be measured annually. The exercise group participates in a supervised training program with weekly sessions from the beginning of October to the end of April. In addition to the supervised sessions the participants train daily at home. From April to October the exercises are performed purely at home. The training regimen consists of balance, strength and impact exercises. The intervention group keeps diary of their daily physical activity. The number and severity of falls are recorded from both the groups.
Read more
The purpose of the study is:
- to identify factors accounting for low BMD in elderly home-dwelling women with severe osteopenia.
- to evaluate how supervised regular weight-bearing exercise program affects BMD in elderly home-dwelling women with severe osteopenia
- to evaluate how supervised regular balance and muscle training affects balance and muscle strength in elderly home-dwelling women with severe osteopenia. In addition the aim is to:
- study how regular supervised exercise affects the incidence and severity of falls, mood and cognitive functions in women with severe osteopenia.
Hypothesis and research methods
The main hypothesis is that long-term supervised, mainly home- based regular impact-type and balance and muscle exercises can improve balance and muscle strength of lower extremities and maintain bone mass in elderly women. We also hypothesize that the incidence of falls is lower in the exercise group than in the controls and that the falls are more injurious in the control group than in the intervention group during the follow-up period
- Conditions
- Bone Mineral Density, Strength, Balance, Osteoporosis, Fractures
- Being tested
- Exercise
- Keywords
- Aging, Osteoporosis, Exercise, Population based, Randomized trial, Falls, Fractures
- Medical subject headings
- Osteoporosis, Fractures, Bone, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Supervised, mainly home-based balance, strength and jumping exercises
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | Control group Receives: Behavioral: Exercise |
| 1 | Experimental | Exercise group Receives: Behavioral: Exercise |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startAug 1998
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Mineral DensityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Juho Vainio Foundation, Miina Sillanpää Foundation, Finnish Cultural Foundation, Oulu Deaconess Institute, Northern Ostrobothnia District Hospital
- Investigators
- Sirkka Keinänen-Kiukaanniemi, MD,PhD, Study director, University of Oulu, Department of Public Health Sciences and General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655577
- Sponsor's protocol ID
- K78751
- Status last verified
- Apr 2008
- First submitted
- 4 Apr 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Korpelainen R, Keinanen-Kiukaanniemi S, Nieminen P, Heikkinen J, Vaananen K, Korpelainen J. Long-term outcomes of exercise: follow-up of a randomized trial in older women with osteopenia. Arch Intern Med. 2010 Sep 27;170(17):1548-56. doi: 10.1001/archinternmed.2010.311.
PubMed 20876406
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Exercise in Prevention of Osteoporotic Fractures in Elderly Women
- ClinicalTrials.gov ID
- NCT00655577
- Acronym / sponsor ID
- K78751
- Conditions
- Bone Mineral Density, Strength, Balance, Osteoporosis, Fractures
- Keywords
- Aging, Osteoporosis, Exercise, Population based, Randomized trial, Falls, Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Ministry of Education, Juho Vainio Foundation, Miina Sillanpää Foundation, Finnish Cultural Foundation, Oulu Deaconess Institute, Northern Ostrobothnia District Hospital
- Study start
- Aug 1998
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 10 Apr 2008 (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 significance of this population-based study is in producing new information for planning interventions and rehabilitation programs for the elderly, planning education of health care personnel and planning national health education programs for different age groups.
The study consists of an epidemiological cross-sectional study and a randomized controlled intervention study. The study population consisted of all the 1689 home-dwelling women born during 1924-1927 residing in Oulu, Northern Finland, who were asked to a screening visit including bone mineral density (BMD) measurement of the distal radius in 1997. 1222 women attended the clinic and were afterwards mailed a postal questionnaire focusing on lifelong risk factors for osteoporosis, e.g. the amount of physical activity at work and during leisure time, daily intake of calcium and use of alcohol and cigarettes. Those with BMD value more than 20% lower than the reference value, underwent a densitometry of the hip. All women with femoral neck BMD more than 20% below the reference value (n=160) were randomly selected to either exercise (n=84) or control (n=76) group. At baseline and after that annually during the 30-month intervention, balance, muscle strength, aerobic capacity, walking speed, cognitive functions and mood are measured from all the participants. Hip BMD will be measured annually. The exercise group participates in a supervised training program with weekly sessions from the beginning of October to the end of April. In addition to the supervised sessions the participants train daily at home. From April to October the exercises are performed purely at home. The training regimen consists of balance, strength and impact exercises. The intervention group keeps diary of their daily physical activity. The number and severity of falls are recorded from both the groups.
The purpose of the study is:
- to identify factors accounting for low BMD in elderly home-dwelling women with severe osteopenia.
- to evaluate how supervised regular weight-bearing exercise program affects BMD in elderly home-dwelling women with severe osteopenia
- to evaluate how supervised regular balance and muscle training affects balance and muscle strength in elderly home-dwelling women with severe osteopenia. In addition the aim is to:
- study how regular supervised exercise affects the incidence and severity of falls, mood and cognitive functions in women with severe osteopenia.
Hypothesis and research methods
The main hypothesis is that long-term supervised, mainly home- based regular impact-type and balance and muscle exercises can improve balance and muscle strength of lower extremities and maintain bone mass in elderly women. We also hypothesize that the incidence of falls is lower in the exercise group than in the controls and that the falls are more injurious in the control group than in the intervention group during the follow-up period
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | Behavioral: ExerciseControl group |
| 1 | Experimental | Behavioral: ExerciseExercise group |
Who may qualify
- Ages
- 71 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- female gender
- born during 1924-1927 and living in Oulu, Finland in 1997
- distal radius BMD value of more than 2 SD below the reference value
- hip BMD value of more than 2SD below the reference value
Key exclusion criteria (7 listed)
- use of walking aid device other than a stick
- bilateral hip joint replacement
- unstable chronic illness
- malignancy
- medication known to affect bone density
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 |
|---|---|---|
| ExerciseSupervised, mainly home-based balance, strength and jumping exercises | Behavioural | 1, 2 |
Primary outcome
Not reported in the source record.
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 10 Apr 2008.
- Derived from this study: PubMed 20876406Korpelainen R, Keinanen-Kiukaanniemi S, Nieminen P, Heikkinen J, Vaananen K, Korpelainen J. Long-term outcomes of exercise: follow-up of a randomized trial in older women with osteopenia. Arch Intern Med. 2010 Sep 27;170(17):1548-56. doi: 10.1001/archinternmed.2010.311.
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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.
Sirkka Keinänen-Kiukaanniemi, MD,PhD study director
University of Oulu, Department of Public Health Sciences and General Practice
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 in people with Bone Mineral Density and Strength, run by University of Oulu at 1 site in Finland.
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 7 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 10 Apr 2008. 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 Finland. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00655577, which also lists 1 linked publication.
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 10 Apr 2008.