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Sponsors and Collaborators: |
University of Oulu Ministry of Education Juho Vainio Foundation Miina Sillanpää Foundation Finnish Cultural Foundation Oulu Deaconess Institute Northern Ostrobothnia District Hospital |
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Information provided by: | University of Oulu |
ClinicalTrials.gov Identifier: | NCT00655577 |
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 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:
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
Condition | Intervention |
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Bone Mineral Density Strength Balance Osteoporosis Fractures |
Behavioral: Exercise |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Role of Exercise in Prevention of Osteoporotic Fractures in Elderly Women |
Enrollment: | 160 |
Study Start Date: | August 1998 |
Study Completion Date: | December 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: No Intervention
Control group
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Behavioral: Exercise
Supervised, mainly home-based balance, strength and jumping exercises
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1: Experimental
Exercise group
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Behavioral: Exercise
Supervised, mainly home-based balance, strength and jumping exercises
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Ages Eligible for Study: | 71 Years to 74 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Finland | |
Oulu Deaconess Institute, Department of Sports Medicine | |
Oulu, Finland, 90100 |
Study Director: | Sirkka Keinänen-Kiukaanniemi, MD,PhD | University of Oulu, Department of Public Health Sciences and General Practice |
Responsible Party: | Oulu Deaconess Institute, Department of Sports Medicine ( Raija Korpelainen ) |
Study ID Numbers: | K78751 |
Study First Received: | April 4, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00655577 History of Changes |
Health Authority: | Finland:Ministry of Education |
Aging Osteoporosis Exercise Population based |
Randomized trial Falls Fractures |
Hip Fractures Musculoskeletal Diseases Fractures, Bone Wounds and Injuries |
Disorders of Environmental Origin Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |