Clinical trial NCT02781974: The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Vertebral Fractures
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 149
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 10 meter habitual walking speed
timeFrame: Up to 18 months
Secondary outcomes:
measure: Quality of life of participants assessed by the questionnaire Qualeffo 41
timeFrame: Up to 18 months
measure: Senior Fitness test
timeFrame: Up to 18 months
measure: Functional reach
timeFrame: Up to 18 months
measure: Four Square Step Test
timeFrame: Up to 18 months
measure: Grip Strength
timeFrame: Up to 18 months
measure: Short Form -36
timeFrame: Up to 18 months
measure: FES-1
timeFrame: Up to 18 months
measure: IPAQ-SF
timeFrame: Up to 18 months
measure: Patient Specific Function Scale
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: OsloMet - Oslo Metropolitan University
Study officials:
References:
citation: Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Skelton DA, Bergland A. Physical fitness in older women with osteoporosis and vertebral fracture after a resistance and balance exercise programme: 3-month post-intervention follow-up of a randomised controlled trial. BMC Musculoskelet Disord. 2020 Jul 18;21(1):471. doi: 10.1186/s12891-020-03495-9.
citation: Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Skelton DA, Bergland A. Effects of a resistance and balance exercise programme on physical fitness, health-related quality of life and fear of falling in older women with osteoporosis and vertebral fracture: a randomized controlled trial. Osteoporos Int. 2020 Jun;31(6):1069-1078. doi: 10.1007/s00198-019-05256-4. Epub 2020 Jan 10.
citation: Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Bergland A. Associations between health-related quality of life, physical function and pain in older women with osteoporosis and vertebral fracture. BMC Geriatr. 2019 Nov 4;19(1):298. doi: 10.1186/s12877-019-1268-y.
citation: Stanghelle B, Bentzen H, Giangregorio L, Pripp AH, Bergland A. Effect of a resistance and balance exercise programme for women with osteoporosis and vertebral fracture: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 Apr 3;19(1):100. doi: 10.1186/s12891-018-2021-y.