Dataset Information

Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health.

ABSTRACT: Osteoporosis is a common complication of aging. Alternatives to pharmacologic treatment are needed for older adults. Nonpharmacologic treatment with low magnitude, high frequency mechanical stimulation has been shown to prevent bone loss in animal and human studies.The VIBES (Vibration to Improve Bone Density in Elderly Subjects) study is a randomized, double-blind, sham-controlled trial of the efficacy of low magnitude, high frequency mechanical stimulation in 200 men and women aged 60 years and older with bone mineral density T-scores by dual X-ray absorptiometry between -1 and -2.5 at entry. Participants are healthy, cognitively intact residents of independent living communities in the Boston area who receive free calcium and Vitamin D supplements. They are randomly assigned to active or sham treatment and stand on their assigned platform once daily for 10 min. All platforms have adherence data collection software downloadable to a laptop computer. Adverse events are closely monitored. 174 participants were randomized and will be followed for 2 years. Almost all active subjects have attained 1 year of follow-up. Bone mineral density is measured by both dual X-ray absorptiometry and quantitative computed tomography at baseline and annually. The main analysis will compare mean changes from baseline in volumetric bone density by quantitative computed tomography in active and sham groups. Adherence and treatment effect magnitude will also be evaluated. Secondary analyses will compare changes in two biochemical markers of bone turnover as well as longitudinal comparisons of muscle and balance endpoints.The VIBES trial has completed its first year of data collection and encountered multiple challenges leading to valuable lessons learned about the areas of recruitment from independent living communities, deployment of multiuser mechanical devices using radio frequency identification cards and electronic adherence monitoring, organization of transportation for imaging at a central site, and the expansion of study aims to include additional musculoskeletal outcomes.These lessons will guide future investigations in studies of individuals of advanced age.

SUBMITTER: Kiel DP

PROVIDER: S-EPMC3136380 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health.

Kiel Douglas P DP Hannan Marian T MT Barton Bruce A BA Bouxsein Mary L ML Lang Thomas F TF Brown Kathleen M KM Shane Elizabeth E Magaziner Jay J Zimmerman Sheryl S Rubin Clinton T CT

Clinical trials (London, England) 20100622 4

<h4>Background</h4>Osteoporosis is a common complication of aging. Alternatives to pharmacologic treatment are needed for older adults. Nonpharmacologic treatment with low magnitude, high frequency mechanical stimulation has been shown to prevent bone loss in animal and human studies.<h4>Methods</h4>The VIBES (Vibration to Improve Bone Density in Elderly Subjects) study is a randomized, double-blind, sham-controlled trial of the efficacy of low magnitude, high frequency mechanical stimulation in ...[more]

PMID: 20571129

Similar Datasets

Project description:Nonpharmacologic approaches to preserve or increase bone mineral density (BMD) include whole-body vibration (WBV), but its efficacy in elderly persons is not clear. Therefore, we conducted the Vibration to Improve Bone in Elderly Subjects (VIBES) trial, a randomized, placebo-controlled trial of 10?minutes of daily WBV (0.3g at 37?Hz) in seniors recruited from 16 independent living communities. The primary outcomes were volumetric BMD of the hip and spine measured by quantitative computed tomography (QCT) and biochemical markers of bone turnover. We randomized 174 men and women (89 active, 85 placebo) with T-scores -1 to -2.5 who were not taking bone active drugs and had no diseases affecting the skeleton (mean age 82?±?7 years, range 65 to 102). Participants received daily calcium (1000?mg) and vitamin D (800 IU). Study platforms were activated using radio frequency ID cards providing electronic adherence monitoring; placebo platforms resembled the active platforms. In total, 61% of participants in the active arm and 73% in the placebo arm completed 24 months. The primary outcomes, median percent changes (interquartile range [IQR]) in total volumetric femoral trabecular BMD (active group (2.2% [-0.8%, 5.2%]) versus placebo 0.4% [-4.8%, 5.0%]) and in mid-vertebral trabecular BMD of L1 and L2 (active group (5.3% [-6.9%, 13.3%]) versus placebo (2.4% [-4.4%, 11.1%]), did not differ between groups (all p values > 0.1). Changes in biochemical markers of bone turnover (P1NP and sCTX) also were not different between groups (p?=?0.19 and p?=?0.97, respectively). In conclusion, this placebo-controlled randomized trial of daily WBV in older adults did not demonstrate evidence of significant beneficial effects on volumetric BMD or bone biomarkers; however, the high variability in vBMD changes limited our power to detect small treatment effects. The beneficial effects of WBV observed in previous studies of younger women may not occur to the same extent in elderly individuals.

Project description:Bone accrual during youth is critical to establish sufficient strength for lifelong skeletal health. Children with cancer may develop low bone mineral density (BMD) any time before or after diagnosis.To evaluate the ability of low-magnitude, high-frequency mechanical stimulation to enhance BMD among childhood cancer survivors.Double-blind randomized clinical trial conducted at St Jude Children's Research Hospital from June 1, 2010, to January 22, 2013, using cancer survivors, ages 7 to 17 years, who were previously treated at St Jude Children's Research Hospital, were in remission, and at least 5 years from diagnosis, with whole-body or lumbar spine BMD z scores of -1.0 or lower. Participants were randomized (stratified by sex and Tanner stage) to either a placebo device or low-magnitude, high-frequency mechanical stimulation device, which was used at home.Placebo or low-magnitude, high-frequency mechanical stimulation (0.3 g; 32-37 Hz) for 2 sessions lasting 10 minutes each, 7 days per week for 1 year. All participants were prescribed daily cholecalciferol (vitamin D) and calcium.Changes in areal and volumetric BMD and bone biomarkers were compared by analysis of variance, adjusted for strata.Of the 65 participants, 32 were randomized to the intervention group (mean [SD] age was 13.6 [3.7] years, 18 [56.2%] were male, and 27 [84.4%] were white), and 33 were randomized to the placebo group (mean [SD] age was 13.6 [2.9] years, 17 [51.5%] were male, and 26 [78.8%] were white). Forty-eight participants completed the trial, 22 in the intervention group and 26 in the placebo group with median adherence of 70.1% for intervention and 63.7% for placebo groups. With intention-to-treat analysis, mean (SD) whole-body BMD z score by dual x-ray absorptiometry improved by 0.25 (0.78) in the intervention (n?=?22), but decreased by -0.19 (0.79) in the placebo group (n?=?26, P?=?.05). Circulating osteocalcin at 12 months correlated with change in total body BMD (r?=?0.35, P?=?.02). Tibial trabecular bone among participants completing 70% or more of the prescribed sessions increased by a mean of 11.2% (95% CI, 5.2 to 17.2%) compared with those completing less than 70% who decreased by a mean of -1.3% (95% CI, -7.3 to 4.7%; P?=?.02). Change in circulating receptor activator of nuclear factor ?-B ligand was higher in the intervention than in the placebo group (0.06 [0.16] vs -0.04 [0.17] pmol/L) (P?=?.04).Pediatric cancer survivors with low BMD may benefit from low-magnitude, high-frequency mechanical stimulation as a novel and safe intervention to optimize peak bone mass during youth, alone or in conjunction with other therapies.clinicaltrials.gov Identifier: NCT01010230.

Project description:ImportanceLow-vision assistive devices are not covered by Medicare and many private insurers, although there is evidence that they can improve functioning and quality of life. Little is known about whether sociodemographic disparities exist in the use of low-vision services by Medicare beneficiaries.ObjectiveTo determine if sociodemographic disparities exist in the use of low-vision services by Medicare beneficiaries.Design, setting, and participantsCross-sectional population-based survey. The National Health Interview Survey is an annually administered nationally representative US survey. Data used in this study were from the 2002, 2008, and 2016 National Health Interview Survey vision supplement. Participants who were Medicare beneficiaries 65 years and older with self-reported vision impairment were included.Main outcomes and measuresMultivariable logistic regression was performed to evaluate if sociodemographic or economic factors were associated with self-reported use of low-vision devices or low-vision rehabilitation among Medicare beneficiaries 65 years and older who self-reported vision impairment.ResultsThere were 3058 participants included in the study. The survey weighted proportion of participants who were men was 37.9% (95% CI, 35.8%-40.0%), while 79.1% (95% CI, 77.2%-80.9%) were non-Hispanic white, 10.2% (95% CI, 9.0%-11.5%) were non-Hispanic black, 6.7% (95% CI, 5.6%-8.1%) were Hispanic, and 4.0% (95% CI, 3.2%-5.0%) identified with another race/ethnicity. The weighted proportion who reported using low-vison devices and low-vision rehabilitation were 26.1% (95% CI, 24.2%-28.1%) and 3.5% (95% CI, 2.8%-4.3%), respectively. In a model adjusted for ocular diagnoses, Hispanic individuals (odds ratio, 0.61; 95% CI, 0.39-0.97) and individuals from other races/ethnicities (odds ratio, 0.39; 95% CI, 0.19-0.80), but not black individuals, were significantly less likely to report using low-vision devices than white individuals. In the model that was not adjusted for ocular diagnoses, black individuals (odds ratio, 0.73; 95% CI, 0.54-0.99) were also significantly less likely to report using low-vision devices. There were no significant racial/ethnic disparities for reported use of low-vision rehabilitation.Conclusions and relevanceAdditional research is needed to clarify the association between sociodemographics and use of low-vision services in the Medicare population. However, policy makers could consider expanding Medicare coverage to include low-vision devices in an effort to address significant disparities in the use of this evidence-based intervention.

Project description:Human mesenchymal stem cells (hMSCs) have the potential to differentiate into different types of mesodermal tissues. In vitro proliferation and differentiation of hMSCs are necessary for bone regeneration in tissue engineering. The present study aimed to design and develop a fluid flow mechanically-assisted cartridge device to enhance the osteogenic differentiation of hMSCs. We used the fluorescence-activated cell-sorting method to analyze the multipotent properties of hMSCs and found that the cultured cells retained their stemness potential. We also evaluated the cell viabilities of the cultured cells via water-soluble tetrazolium salt 1 (WST-1) assay under different rates of flow (0.035, 0.21, and 0.35 mL/min) and static conditions and found that the cell growth rate was approximately 12% higher in the 0.035 mL/min flow condition than the other conditions. Moreover, the cultured cells were healthy and adhered properly to the culture substrate. Enhanced mineralization and alkaline phosphatase activity were also observed under different perfusion conditions compared to the static conditions, indicating that the applied conditions play important roles in the proliferation and differentiation of hMSCs. Furthermore, we determined the expression levels of osteogenesis-related genes, including the runt-related protein 2 (Runx2), collagen type I (Col1), osteopontin (OPN), and osteocalcin (OCN), under various perfusion vis-à-vis static conditions and found that they were significantly affected by the applied conditions. Furthermore, the fluorescence intensities of OCN and OPN osteogenic gene markers were found to be enhanced in the 0.035 mL/min flow condition compared to the control, indicating that it was a suitable condition for osteogenic differentiation. Taken together, the findings of this study reveal that the developed cartridge device promotes the proliferation and differentiation of hMSCs and can potentially be used in the field of tissue engineering.

Dataset Information

Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health.

Publications

Insights from the conduct of a device trial in older persons: low magnitude mechanical stimulation for musculoskeletal health.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets