Low-magnitude High-frequency Vibration Study on Fracture Rate in Community Elderly

NCT00973167 | Completed Phase 2

• 1 other identifier: 469508
• Study Type: interventional
• Target: 704
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractures

Keywords

Fracture rate; Fracture risks

Outcome Measures

Primary Outcomes (1)

• Fracture rate

  up to 18 months

Secondary Outcomes (1)

• Balancing ability

  up to 18 months

Study Arms (2)

Control

NO INTERVENTION

Remains sedentary with normal lifestyle

Treatment

EXPERIMENTAL

Receive LMHFV treatment for 18 months.

Device: Low-magnitude high-frequency vibration treatment

Interventions

Low-magnitude high-frequency vibration treatment DEVICE

Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5 days/week

Treatment

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years old or above
• independent in accessing the centres

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 24676848 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kwok-Sui Leung, MD

  Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: September 9, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

CN (1)