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

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

Tracking Information

• First Submitted Date: May 18, 2016
• First Posted Date: May 25, 2016
• Last Update Posted Date: March 8, 2019
• Study Start Date: January 2016
• Actual Primary Completion Date: October 12, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 24, 2016): 10 meter habitual walking speed [ Time Frame: Up to 18 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 23, 2016)

• 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 ]

• Original Secondary Outcome Measures (submitted: May 24, 2016): Quality of life of participants assessed by the questionnaire Qualeffo 41 [ Time Frame: Up to 18 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Osteoporosis
• Vertebral Fractures

Intervention

Other: Exercise

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

Study Arms

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

Publications *

• 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.
• 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. Erratum in: Osteoporos Int. 2020 Apr 27;:.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 6, 2019): 149
• Original Estimated Enrollment (submitted: May 24, 2016): 150
• Actual Study Completion Date: October 12, 2018
• Actual Primary Completion Date: October 12, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT02781974
• Other Study ID Numbers: 2014/2050
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Brita Stanghelle, Oslo Metropolitan University
• Study Sponsor: Oslo Metropolitan University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Oslo Metropolitan University
• Verification Date: March 2019