The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 12, 2018

Interventions

  • Other: Exercise
    • Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Intervention consists of strength and balance exercise in group sessions, twice a week for 12 weeks
  • No Intervention: Control
    • Participants allocated in the control group are instructed to “live as usual”

Clinical Trial Outcome Measures

Primary Measures

  • 10 meter habitual walking speed
    • Time Frame: Up to 18 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Oslo Metropolitan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brita Stanghelle, phd-student – Oslo Metropolitan University

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