Exercise and Prevention of Hip Fractures

NCT00655577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2008-04-10

No results posted yet for this study

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:

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

Conditions

  • Bone Mineral Density
  • Strength
  • Balance
  • Osteoporosis
  • Fractures

Interventions

BEHAVIORAL

Exercise

Supervised, mainly home-based balance, strength and jumping exercises

Sponsors & Collaborators

  • Ministry of Education

    collaborator AMBIG
  • Juho Vainio Foundation

    collaborator OTHER
  • Miina Sillanpää Foundation

    collaborator UNKNOWN
  • Finnish Cultural Foundation

    collaborator OTHER
  • Oulu Deaconess Institute

    collaborator OTHER
  • Northern Ostrobothnia District Hospital

    collaborator UNKNOWN
  • University of Oulu

    lead OTHER

Principal Investigators

  • Sirkka Keinänen-Kiukaanniemi, MD,PhD · University of Oulu, Department of Public Health Sciences and General Practice

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
71 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-08-31
Primary Completion
2004-12-31
Completion
2004-12-31

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00655577 on ClinicalTrials.gov