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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02781974
Enrollment
149
Registered
2016-05-25
Start date
2016-01-31
Completion date
2018-10-12
Last updated
2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Vertebral Fractures

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.

Interventions

OTHERExercise

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

Sponsors

Oslo Metropolitan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
10 meter habitual walking speedUp to 18 months

Secondary

MeasureTime frame
Senior Fitness testUp to 18 months
Functional reachUp to 18 months
Four Square Step TestUp to 18 months
Grip StrengthUp to 18 months
Quality of life of participants assessed by the questionnaire Qualeffo 41Up to 18 months
FES-1Up to 18 months
IPAQ-SFUp to 18 months
Patient Specific Function ScaleUp to 18 months
Short Form -36Up to 18 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026