Low-magnitude High-frequency Vibration Study on Fracture Rate in Community Elderly
Primary Purpose
Fractures
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Low-magnitude high-frequency vibration treatment
Sponsored by
About this trial
This is an interventional treatment trial for Fractures focused on measuring Fracture rate, Fracture risks
Eligibility Criteria
Inclusion Criteria:
- 65 years old or above
- independent in accessing the centres
Exclusion Criteria:
- having habitual exercise or participate in supervised exercise
- having drug treatment that affects normal metabolism of musculoskeletal system
- having hypo- or hyperparathyroidism, renal, liver or other chronic diseases
- having low-energy fracture history
- previous or current smokers or drinkers
Sites / Locations
- Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Treatment
Arm Description
Remains sedentary with normal lifestyle
Receive LMHFV treatment for 18 months.
Outcomes
Primary Outcome Measures
Fracture rate
Secondary Outcome Measures
Balancing ability
Full Information
NCT ID
NCT00973167
First Posted
August 5, 2009
Last Updated
April 23, 2012
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00973167
Brief Title
Low-magnitude High-frequency Vibration Study on Fracture Rate in Community Elderly
Official Title
The Efficacy of Low-magnitude, High-frequency Vibration Treatment on Reducing Fracture Risks and Fracture Incidences in the Community Elderly - a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fragility fracture is common due to global aging problem, incurring huge healthcare expenditure. The occurrence of fragility fracture is usually caused by a fall incidence of an elderly with low bone quality and poor balancing ability. Therefore, any approach to improve or retard both sarcopenia and osteoporosis will be helpful to prevent osteoporotic fracture incidence. With the intensive research on low magnitude high frequency vibration (LMHFV), many scientific evidences support the application of this biophysical modality on elderly to maintain or improve the musculoskeletal tissues in elderly.
Many previous studies showed the osteogenic properties of vibration treatment and its positive effects on muscular performance and blood circulation. The investigators' previous reports also indicated that LMHFV could enhance the bone quality in spine and tibia in elderly after one-year intervention, as well as the balancing ability with high compliance. In animal studies, the application of LMHFV on fracture healing also demonstrated the significant acceleration of healing by inducing callus formation and maturation, from which upregulation of collagen I, II and BMP-2 gene expression was detected at molecular level. To date, the long-term efficacy of LMHFV on reducing fracture risks and fracture rate is, however, not available, which needs a systematic large-scale study to answer this important research question.
Therefore, the hypothesis of this study is that LMHFV can maintain or enhance the performance of various tissues of the musculoskeletal system in community elderly, thus reducing the fracture risks and fracture rate. A large-scale prospective randomized clinical trial will be conducted in multiple communities to investigate the long-term effect of LMHFV on fracture rate and reduction of fracture risks in community elderly, in which multi-factorial effects, in terms of muscle and bone, on musculoskeletal system will also be evaluated. A total of 704 elderly from 28 community centres will be recruited within 1.5-year time for a 18-month LMHFV treatment, who will be assessed on the fracture risks at fixed time points while their fracture rates on the third year of this study will be regarded as primary outcome for analysis. The findings of this study will provide very useful scientific data to support the application of LMHFV for elderly. The ultimate goal is to reduce the fracture rate and the quality of life of community-living elderly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures
Keywords
Fracture rate, Fracture risks
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
704 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Remains sedentary with normal lifestyle
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Receive LMHFV treatment for 18 months.
Intervention Type
Device
Intervention Name(s)
Low-magnitude high-frequency vibration treatment
Intervention Description
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5 days/week
Primary Outcome Measure Information:
Title
Fracture rate
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Balancing ability
Time Frame
up to 18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
65 years old or above
independent in accessing the centres
Exclusion Criteria:
having habitual exercise or participate in supervised exercise
having drug treatment that affects normal metabolism of musculoskeletal system
having hypo- or hyperparathyroidism, renal, liver or other chronic diseases
having low-energy fracture history
previous or current smokers or drinkers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok-Sui Leung, MD
Organizational Affiliation
Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24676848
Citation
Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.
Results Reference
derived
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Low-magnitude High-frequency Vibration Study on Fracture Rate in Community Elderly
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