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Trial record 46 of 228 for:    strength | Norway

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Metropolitan University

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date March 8, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date October 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2016)
10 meter habitual walking speed [ Time Frame: Up to 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Vertebral Fractures
Intervention  ICMJE Other: Exercise
Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance
Study Arms  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2019)
149
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2016)
150
Actual Study Completion Date  ICMJE October 12, 2018
Actual Primary Completion Date October 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02781974
Other Study ID Numbers  ICMJE 2014/2050
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brita Stanghelle, Oslo Metropolitan University
Study Sponsor  ICMJE Oslo Metropolitan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oslo Metropolitan University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP