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Completed

NCT Number: NCT02781974

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

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.

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Key information

Conditions

Osteoporosis Back Injuries Bone Diseases Bone Diseases, Metabolic Fractures, Bone Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Spinal Fractures Spinal Injuries Vertebral Fractures Wounds and Injuries

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OsloMet - Oslo Metropolitan University

Oslo, 0130, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance

Primary outcomes

  1. 10 meter habitual walking speed

    Time frame: Up to 18 months

Secondary outcomes

  1. Quality of life of participants assessed by the questionnaire Qualeffo 41

    Time frame: Up to 18 months

  2. Senior Fitness test

    Time frame: Up to 18 months

  3. Functional reach

    Time frame: Up to 18 months

  4. Four Square Step Test

    Time frame: Up to 18 months

  5. Grip Strength

    Time frame: Up to 18 months

  6. Short Form -36

    Time frame: Up to 18 months

  7. FES-1

    Time frame: Up to 18 months

  8. IPAQ-SF

    Time frame: Up to 18 months

  9. Patient Specific Function Scale

    Time frame: Up to 18 months

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 25, 2016
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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