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

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ClinicalTrials.gov Identifier: NCT02781974
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Brita Stanghelle, Oslo and Akershus University College of Applied Sciences

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Vertebral Fractures Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture: A Randomized Controlled Trial
Study Start Date : January 2016
Actual Primary Completion Date : October 12, 2018
Actual Study Completion Date : October 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Intervention consists of strength and balance exercise in group sessions, twice a week for 12 weeks
Other: Exercise
Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance

No Intervention: Control
Participants allocated in the control group are instructed to "live as usual"



Primary Outcome Measures :
  1. 10 meter habitual walking speed [ Time Frame: Up to 18 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781974


Locations
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Norway
OsloMet - Oslo Metropolitan University
Oslo, Norway, 0130
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brita Stanghelle, phd-student, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT02781974     History of Changes
Other Study ID Numbers: 2014/2050
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Osteoporosis
Fractures, Bone
Spinal Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Back Injuries