本研究參與者整體生理指標同質性高,在相類似的背景基礎下,實驗組在提升身體 活動量後,整體心血管功能 (血壓、自律神經) 較控制組有顯著改善,表示四週的提升 身體活動量對身體的生理功能是有幫助的。更進一步得知,實驗組的血壓於介入的第二 週就有顯著下降,且自律神經功能於介入的第三週有顯著改善,不同於以往的研究僅注 重前測與後測間的差異,而忽略了介入期間的改變。雖然實驗組的 PSQI 睡眠品質分數 有下降但並未達顯著差異,我們所推論的可能原因包括:介入的時間太短,能夠改善的
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睡眠品質有限以及更年期症候群婦女容易因生理功能的變化而引起心理壓力,導致睡眠 品質不佳。但實驗組 ESS 嗜睡量表的分數於介入的第一週就有顯著下降,表示白天的精 神狀況變好,不易打瞌睡。
身體活動量的介入對於心率變異性具有正向影響,最重要的是在介入後,早上與晚 上的心率變異性差異變大,表示身體狀況較佳,當外在環境改變時,自律神經能夠快速 且有效的調控身體,做出即時反應。
本研究針對潛在高血壓的更年期婦女合併睡眠問題做為研究對象,有這樣問題之婦 女不在少數,也藉此鼓勵有同樣問題的女性在整體生理功能未嚴重退化前,盡早養成運 動習慣或提升身體活動量來降低老化時所帶來之生理功能之影響。
二、建議
(一) 由於整個收案過程從前測、四週身體活動量介入及後測僅有四週的時間,對於四週 後心血管功能及睡眠品質的後續影響會是如何無法做更多的探討,以後研究可以在身體 活動量介入結束後,繼續收集參與者之生理參數,以便了解運動對於心血管功能的保護 效果能夠持續多長的時間。
(二) 本研究提升身體活動量的介入並未能量化其身體活動量,僅要求參與者每週至少三 次以上、每次至少三十分鐘的額外身體活動量,並以運動日誌做紀錄,所以無法得知身 體活動量增加多少有助於改善心血管功能,建議以後的研究可以使用儀器記錄身體活動 量,以量化其標準,做為以後建議想要改善心血管功能的人之指標。
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十、 誰可以使用您的資料:
依「人體研究法」 、 「研究用人體檢體採集與使用注意事項」及「人體 生物資料庫管理條例」規定,唯有計畫主持人、共同/協同主持人及 本計畫含括之人員可於研究進行期間依本研究所訂臨床試驗計畫使 用您的檢體,如於研究結束後仍需使用,將依法請您另簽一份同意 書。
十一、 研究結束後資料處理方法:
研究結束後,屆時將徵詢您的意見,是否願意提供後續研究使用。
十二、 如果您中途退出研究,其資料處理方法 陽明大學銷毀。
十三、 如本計畫研究成果獲得學術文獻發表、智慧財產及實質效益時,國 立陽明大學將作為從事疾病診斷、預防、治療及研究等醫學用途。
十四、 權利
1. 參加本研究皆不須繳交任何費用。
2. 您有不參加研究的權利,並有權隨時退出本研究,且不會引起任何 不愉快或影響應有的權利。
3. 研究過程中有關的任何重大發現都將提供給您。
4. 如果您因為參與本研究,而發生任何不適或疑問可隨時與計畫主持 人楊靜修聯絡(聯絡電話:02-28267000#6156) 。如您對參與研究 的相關權益有疑問,您可以和國立陽明大學人體研究暨倫理委員 會郭樓惠小姐聯絡(聯絡電話: 2826-7000分機6217或5337)
5. 您將持有一份已簽署之受試者同意書。
十五、 聲明
計畫主持人楊靜修已完整地向我說明本研究之性質與目的。計畫主持 楊靜修已回答我有關藥品與研究的問題,並已解釋我有權隨時退出研 究工作,且不會引起任何不愉快或任何不良後果。
十六、 簽名
主要主持人已詳細解釋有關本研究計畫中上述研究方法的性質與目的,及
可能產生的危險與利益。
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(1) 無行為能力人(在民法是指七歲以下之兒童,法律宣告禁治產權者);由法定代 理人簽名。禁治產人由監護人擔任其法定代理人。
(2) 限制行為能力人(在民法是指七歲以上、二十歲以下之未成年人);則需受試者 與法定代理人共同簽名。
(3) 七歲~十二歲的受試者:須另加一份贊同同意書,請用圖案表示或注音,取得 其贊同。
註5. 受試者因精神障礙或其他心智缺陷,致其為意思表示或受意思表示,或辨識其意思表 示效果之能力,顯有不足,而受法院之輔助宣告者,應得輔助人之同意。
註6. 受試者雖非無行為能力或限制行為能力者,但因意識混亂或有精神與智能障礙,而無 法進行有效溝通和判斷時,由有同意權之人為之。前項有同意權人為配偶及同居之親 屬。
註7. 見證人必須由其本人簽名,並且載明日期始得生效(試驗相關人員不得為見證人)。
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運動 每週______ 次,每次______分鐘,進行_________運動 加班 每週______ 次,每次______小時
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附錄五
一週運動紀錄表
姓名:__________ 填表日期:____年
星期一 健走活動 其他運動(類型) 1: 2: 3:
月 日 □ 是 □ 否 運動時間 備註:
星期二 健走活動 其他運動(類型) 1: 2: 3:
月 日 □ 是 □ 否 運動時間 備註:
星期三 健走活動 其他運動(類型) 1: 2: 3:
月 日 □ 是 □ 否 運動時間 備註:
星期四 健走活動 其他運動(類型) 1: 2: 3:
月 日 □ 是 □ 否 運動時間 備註:
星期五 健走活動 其他運動(類型) 1: 2: 3:
月 日 □ 是 □ 否 運動時間 備註:
星期六 健走活動 其他運動(類型) 1: 2: 3:
月 日 □ 是 □ 否 運動時間 備註:
星期日 健走活動 其他運動(類型) 1: 2: 3:
月 日 □ 是 □ 否 運動時間
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附錄六
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附錄七
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