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Clinical Trials/NCT02781974
NCT02781974
Completed
Not Applicable

The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture: A Randomized Controlled Trial

Oslo Metropolitan University1 site in 1 country149 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis
Sponsor
Oslo Metropolitan University
Enrollment
149
Locations
1
Primary Endpoint
10 meter habitual walking speed
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The study is a parallel-group single blinded randomized controlled trial, examining the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the intervention group and the control group. The intervention will follow newly developed exercise recommendations for people with osteoporosis and vertebral fractures, which states the balance- and strength exercises should be performed at least twice a week. The intervention is a group exercise session circuit program lasting for 12 weeks. The participants will be tested at baseline, and followed up at 3 months and 6 months.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
October 12, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Oslo Metropolitan University
Responsible Party
Principal Investigator
Principal Investigator

Brita Stanghelle

phd-student

Oslo Metropolitan University

Eligibility Criteria

Inclusion Criteria

  • Women over 65 years, living at home, able to walk with or without walking aids
  • having osteoporosis verified by DXA scan (-2,5)
  • at least one vertebral fracture, verified by X-ray

Exclusion Criteria

  • Health conditions that make it unsafe to exercise
  • not able to understand and speak Norwegian adequately to participate in the intervention

Outcomes

Primary Outcomes

10 meter habitual walking speed

Time Frame: Up to 18 months

Secondary Outcomes

  • Senior Fitness test(Up to 18 months)
  • Functional reach(Up to 18 months)
  • Quality of life of participants assessed by the questionnaire Qualeffo 41(Up to 18 months)
  • Four Square Step Test(Up to 18 months)
  • Short Form -36(Up to 18 months)
  • FES-1(Up to 18 months)
  • Grip Strength(Up to 18 months)
  • IPAQ-SF(Up to 18 months)
  • Patient Specific Function Scale(Up to 18 months)

Study Sites (1)

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