本研究為一經財團法人天主教聖馬爾定醫院之人體試驗委員會(IRB)許可之隨機、雙盲之臨床先驅性研究。選擇長期照護機構(台南市立仁愛之家)大於65歲且能站立20分鐘之老人及非老人共32人，依抽籤來進行隨機分組，分成實驗組及對照組, 其中包含實驗組(治療組二部)及對照組(非治療組一部)各約10-11人，以每日總站立於震動治療機(JUVENT 1000)上及安慰機(placebo)各20分鐘。於0，3，6個月由DXA來追蹤受試者骨質密度之增減及檢查血液中之骨生化指標。

在統計分析上我們最後只針對有完整配合研究計晝的樣本(共25人)進行統計分析，先進行描述性分析，接著利用卡方檢定比較兩組中性別是否有顯著差異，並利用無母數檢定比較兩組中的年齡、參與率、身體質量指數是否有顯著差異。接下來利用無母數檢定比較(1)兩組間骨質密度變化率是否有顯著差異，(2)實驗組前測與後測的成對樣本檢定，(3)透過迴歸把對骨質變化率有關的解釋變數選出來，(4)利用ANCOVA做出最佳的模型，來判斷分組是否顯著。

整體而言，以世界衛生組織定義之骨質疏鬆與低骨量個案分別為28.0%及32.0%，其中男性(n=12)有41.7%為低骨量，16.7%為骨質疏鬆；女性(n=13)有15.4%為低骨量，46.2%為骨質疏鬆。在介入前，實驗組與對照組分別接受了移動式的DXA掃描，全髖骨骨密度分別為0.760±0.157及 0.797±0.112 (兩組之間比較p=0.562)；股骨頸骨密度分別為0.621±0.123及 0.675±0.138 (兩組之間比較p=0.331)。

受試者平均接受震動治療天數為99天，以180天計算之平均遵醫囑率為55%，六個月後實驗組與對照組全髖骨骨密度分別為0.756±0.136(與前測比較p=0.68)及0.794±0.123(與前測比較p=0.819)；股骨頸骨密度為0.609±0.125 (與前測比較p=0.018)及 0.686±0.131(與前測比較p=0.381) 實驗組與對照組全髖骨骨密度皆是呈現流失的現像，尤其實驗組更為明顯，股骨頸來看；則發現實驗組有更快的骨密度流失，有統計學上的意義，對照組則是沒有明顯的下滑，但不具統計學上的意義。
因為受試者的差異性太大，故挑出一些可能影響骨密度結果的變數以共變數分析(ANCOVA) 來調整住民的年齡、性別、遵醫囑率及身體質量指數並統計震動治療介入前後兩組在骨密度的改變率發現在股骨頸略有變差(p=0.045) 顯示了股骨頸的骨密度變化或許是有統計學上的意義，但是全髖骨則無差異(p=0.638)。

受試者的骨質除了用DXA來檢測之外，血液測量項目為骨形成(Osteocalcin)及再吸收(CTX)的一些血液骨指標變化，維他命 D、甲狀腺、副甲狀腺功能、肝臟及腎臟功能、及男、女性賀爾蒙等。利用成對t檢天看出實驗組的15人中維他命D有顯著的下降(P<0.001)，因為整個臨床試驗是由八月的盛夏多日照開始，然後一直到次年的ニ月冬季低日照，維他命 D顯著的下降或許跟日照有關。其他血液檢查則無法找出統計學上的意義。受試者之遵醫囑率(參與率) 也是一大問題，也對整個研究有絕對的影響(P=0.005)，對於平均只有55%的參與率是本次研究的一大困難(相較於文獻回顧高於80%)。年齡、BMI、首測之全髖骨、首測之股骨頸則沒有統計學上的意義。

初步得到的結論是所有的住民之骨質都有流失，只是速度有所不同，震動治療介入沒有得到我們預期的改善，但是我們只是看到雙能量X光吸收儀(DXA)機器自動分析之骨質變化，尚未將DXA影像之骨刺及壓迫性骨折正確地考慮進去，仁愛之家受試者之樣本太小、受試者之體內維他命D濃度變化、遵醫囑性及介入時間太短都可能是本研究不盡完善和未來需加強的部分。整體而言，震動治療機(JUVENT 1000) 具有無痛、無明顯副作用及便於攜帶，是值得進一步研究預防骨質疏鬆的好方法。

This is a double blind randomized control trail approved by IRB of St. Martin hospital, Chia-yi city, a pilot study. Sample collected from the long term care facility(台南市立仁愛之家), participants aged above 65, capable of standing up on vibration plate form for 20 minutes and survive study period of 6 month were recruited. 32 subjects were then randomized into two groups ( experimental and control groups), both groups were required to stand on Juvent 1000 vibration plateform for 20 minutes/day, at least 5 days a week. BMD checked by mobile DXA, blood checked for cholesterol, PTH, liver function, vitamin D …etc.

At the end of study, we excluded those who could not comply the study plane, 25 subjects were put into statistic analysis, descriptive analysis was performed first, then chi square, nonparametric test for factors such as age, BMI, participation rate. (1) Nonparametric test for the BMD changes in both groups (2) Paired sample test for experimental and control groups(3)Regression analysis to single out the possible influential factors that affects BMD changes(4)ANCOVA to choose the best model and do adjustments.

Base on the WHO definition, we found out that osteoporosis prevalence was 28.0%, low bone mass was 16.7%, male (n=12) is 41.7% with low bone mass, 16.7%with osteoporosis, female (n=13) is 15.4 with low bone mass,.46.2% with osteoporosis.

Prior to intervention, all of the subjects(experimental and control)were scanned with mobile DXA, with total hips BMD with 0.760±0.157/0.797±0.112 (p=0.562), femoral neck BMD were 0.621±0.123 and 0.675±0.138 (=0.331).Their average participation rate was 99 days within 6 months, divided with 180 days; their average compliance rate was 55% only (lower than review article, higher than 80% in average). After 6 months intervention, (Experimental and control groups respectively) revealed total hip BMD was 0.756±0.136(compared with previous test p=0.68)and 0.794±0.123(compared with previous test p=0.819)；Femoral neck BMD was 0.609±0.125 (compared with previous test p=0.018) and 0.686±0.131 (compared with previous test p=0.381). Experimental group BMD deline with statistic significance, control groups was losing BMD in 6 months as well but not statistically significant. We single out some factors (age, BMI, compliance, gender and serum vitamin D level) and analyzed with ANCOVA, trying to find out the most influential factors. Data revealed femoral neck BMD declined with statistical significance (p=0.045), total hip is not statistically significant (p=0.638).

Aside from the DXA data, we also analyze the blood serum ( osteocalcin, CTX, vitamin D, liver and renal functions, PTH, cholesterol, male and female hormone, paired t test used and revealed experimental group with significant serum vitamin D decline( P=0.000), this finding may be due to study design (from hot summer to cold winter). For the rest of the blood test were all with no statistic significant, and our finding may be affected by low participation rate (P=0.005). Age, BMI, total hip and femoral neck were of no statistic significance.

literatures review point out that BMD should improve after vibration therapy, in this study we just don’t see results as we expected, all the participants were with different degrees of BMD declines after 6 months intervention, DXA pictures need to be further analyzed due to artifacts and possible compression fracture, small sample size, vitamin D level changes, low participation rate, and relatively short period of intervention are all influential factors need to be further examined and studied. Generally speaking, JUVENT 1000 vibration plateform is a painless, no obvious side-effect, and easy to carry equitment for preventing osteoporosis, further study is worthwhile.

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