Exercise and Prevention of Hip Fractures
Primary Purpose
Bone Mineral Density, Strength, Balance
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Bone Mineral Density focused on measuring Aging, Osteoporosis, Exercise, Population based, Randomized trial, Falls, Fractures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Oulu Deaconess Institute, Department of Sports Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
2
1
Arm Description
Control group
Exercise group
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00655577
First Posted
April 4, 2008
Last Updated
April 4, 2008
Sponsor
University of Oulu
Collaborators
Ministry of Education, Juho Vainio Foundation, Miina Sillanpää Foundation, Finnish Cultural Foundation, Oulu Deaconess Institute, Northern Ostrobothnia District Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00655577
Brief Title
Exercise and Prevention of Hip Fractures
Official Title
Role of Exercise in Prevention of Osteoporotic Fractures in Elderly Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
Collaborators
Ministry of Education, Juho Vainio Foundation, Miina Sillanpää Foundation, Finnish Cultural Foundation, Oulu Deaconess Institute, Northern Ostrobothnia District Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Mineral Density, Strength, Balance, Osteoporosis, Fractures
Keywords
Aging, Osteoporosis, Exercise, Population based, Randomized trial, Falls, Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
No Intervention
Arm Description
Control group
Arm Title
1
Arm Type
Experimental
Arm Description
Exercise group
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Supervised, mainly home-based balance, strength and jumping exercises
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
71 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirkka Keinänen-Kiukaanniemi, MD,PhD
Organizational Affiliation
University of Oulu, Department of Public Health Sciences and General Practice
Official's Role
Study Director
Facility Information:
Facility Name
Oulu Deaconess Institute, Department of Sports Medicine
City
Oulu
ZIP/Postal Code
90100
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20876406
Citation
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.
Results Reference
derived
Learn more about this trial
Exercise and Prevention of Hip Fractures
We'll reach out to this number within 24 hrs