Exercise and Prevention of Hip Fractures

This study has been completed.
Sponsor:
Collaborators:
Ministry of Education
Juho Vainio Foundation
Miina Sillanpää Foundation
Finnish Cultural Foundation
Oulu Deaconess Institute
Northern Ostrobothnia District Hospital
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00655577
First received: April 4, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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:

  1. to identify factors accounting for low BMD in elderly home-dwelling women with severe osteopenia.
  2. to evaluate how supervised regular weight-bearing exercise program affects BMD in elderly home-dwelling women with severe osteopenia
  3. 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:

  4. 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


Condition Intervention
Bone Mineral Density
Strength
Balance
Osteoporosis
Fractures
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Exercise in Prevention of Osteoporotic Fractures in Elderly Women

Resource links provided by NLM:


Further study details as provided by University of Oulu:

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
No Intervention: 2
Control group
Behavioral: Exercise
Supervised, mainly home-based balance, strength and jumping exercises
Experimental: 1
Exercise group
Behavioral: Exercise
Supervised, mainly home-based balance, strength and jumping exercises

  Eligibility

Ages Eligible for Study:   71 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655577

Locations
Finland
Oulu Deaconess Institute, Department of Sports Medicine
Oulu, Finland, 90100
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
Investigators
Study Director: Sirkka Keinänen-Kiukaanniemi, MD,PhD University of Oulu, Department of Public Health Sciences and General Practice
  More Information

No publications provided by University of Oulu

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raija Korpelainen, Oulu Deaconess Institute, Department of Sports Medicine
ClinicalTrials.gov Identifier: NCT00655577     History of Changes
Other Study ID Numbers: K78751
Study First Received: April 4, 2008
Last Updated: April 4, 2008
Health Authority: Finland:Ministry of Education

Keywords provided by University of Oulu:
Aging
Osteoporosis
Exercise
Population based
Randomized trial
Falls
Fractures

Additional relevant MeSH terms:
Fractures, Bone
Osteoporosis
Osteoporotic Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014