Exercise and Prevention of Hip Fractures

NCT00655577 | Completed

• 1 other identifier: K78751
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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:

1. 1.to identify factors accounting for low BMD in elderly home-dwelling women with severe osteopenia.
2. 2.to evaluate how supervised regular weight-bearing exercise program affects BMD in elderly home-dwelling women with severe osteopenia
3. 3.to evaluate how supervised regular balance and muscle training affects balance and muscle strength in elderly home-dwelling women with severe osteopenia.
4. 4.study how regular supervised exercise affects the incidence and severity of falls, mood and cognitive functions in women with severe osteopenia.

Conditions

Bone Mineral Density; Strength; Balance; Osteoporosis; Fractures

Keywords

Aging; Osteoporosis; Exercise; Population based; Randomized trial; Falls; Fractures

Study Arms (2)

2

NO INTERVENTION

Control group

Behavioral: Exercise

1

EXPERIMENTAL

Exercise group

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

1; 2

Eligibility Criteria

• Age: 71 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Ministry of Education: collaborator
• Juho Vainio Foundation: collaborator
• Miina Sillanpää Foundation: collaborator
• Finnish Cultural Foundation: collaborator
• Oulu Deaconess Institute: collaborator
• Northern Ostrobothnia District Hospital: collaborator

Study Sites (1)

Oulu Deaconess Institute, Department of Sports Medicine

Oulu, 90100, Finland

Location

Related Publications (1)

• 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.

  PMID: 20876406 DERIVED

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sirkka Keinänen-Kiukaanniemi, MD,PhD

  University of Oulu, Department of Public Health Sciences and General Practice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: August 1, 1998
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: April 10, 2008

Record last verified: 2008-04

Locations

FI (1)