Trial record 46 of 253 for:
strength | Norway
The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture
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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
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Sponsor:
Oslo Metropolitan University
Information provided by (Responsible Party):
Brita Stanghelle, Oslo Metropolitan University
Tracking Information | |||
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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 |
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 |
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Original Secondary Outcome Measures ICMJE |
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 |
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Condition ICMJE |
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Intervention ICMJE | Other: Exercise
Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
149 | ||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |