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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000033717
受付番号 R000038447
科学的試験名
一般公開日(本登録希望日) 2018/08/10
最終更新日 2019/10/05

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Effects of Chinese massage combined with soy milk supplement on the recovery of exercise fatigue and exercise performance
一般向け試験名略称/Acronym
Effects of Chinese massage plus soy milk supplementation on post-exercise recovery
科学的試験名/Scientific Title
Effects of Chinese massage combined with soy milk supplement on the recovery of exercise fatigue and exercise performance
科学的試験名略称/Scientific Title:Acronym
Effects of Chinese massage plus soy milk supplementation on post-exercise recovery
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
The healthy adults who routinely take exercise.
疾患区分1/Classification by specialty
成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To investigate the clinical benefits, such as post-exercise recovery and anti-fatigue effects, associated with ingestion of sugar-added soy milk beverage for the healthy adult with routinely take exercise.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
5-km cycling time-trial test by bicycle ergometer at before main-exercise (15-km self-paced cycling exercise) and the next day.
副次アウトカム評価項目/Key secondary outcomes
1. Fatigue related scales (VAS, modified Borg scale)
2. Fatigue related biochemical examination of blood
3. Cognition related task performance
(They are assessed at before main-exercise (15-km self-paced cycling exercise) and the next day.)

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design クロスオーバー試験/Cross-over
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control プラセボ・シャム対照/Placebo
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 3
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
食品/Food
介入1/Interventions/Control_1
The subjects are instructed to take commercially available sugar-added soy milk beverage at the time of immediately after the main-exercise (300 ml) and after the completion of post-exercise Chinese massage intervention (at one-hour after the main-exercise; 300 ml).
介入2/Interventions/Control_2
The subjects are instructed to take artificial sweeten pure water at the time of immediately after the main-exercise (300 ml) and after the completion of post-exercise Chinese massage intervention (at one-hour after the main-exercise; 300 ml).
介入3/Interventions/Control_3
The subjects are instructed to take artificial sweeten pure water at the time of immediately after the main-exercise (300 ml) and at one-hour after the main-exercise (300 ml). [Chinese massage intervention].
介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
40 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who routinely take exercise.
3. Subjects who have no clinical skeletomuscular problems within 12-weeks prior to the study.
4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
除外基準/Key exclusion criteria
1. Subjects with respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who can't take exercise tolerance by bicycle ergometer.
3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
4. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
5. Subjects who have cognitive disorder or who have possibility of the disorder.
6. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
目標参加者数/Target sample size 16

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Yi-Hung
ミドルネーム
Liao
所属組織/Organization
National Taipei University of Nursing and Health Sciences
所属部署/Division name
Department of Exercise and Health Science
郵便番号/Zip code 11219
住所/Address
No.365, Ming-Te Road, Peitou District,, Taipei City
電話/TEL +886228227101
Email/Email yihungliao.henry@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Yi-Hung
ミドルネーム
Liao
組織名/Organization
National Taipei University of Nursing and Health Sciences
部署名/Division name
Department of Exercise and Health Science
郵便番号/Zip code 11219
住所/Address
No.365, Ming-Te Road, Peitou District,
電話/TEL +886228227101
試験のホームページURL/Homepage URL
Email/Email yihungliao.henry@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 National Taipei University of Nursing and Health Sciences
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 National Taipei University of Nursing and Health Sciences, Taipei City, Taiwan
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
IRB of Fu Jen Catholic University
住所/Address
No.510, Zhongzheng Rd., Xinzhuang Dist., New Taipei City 24205, Taiwan
電話/Tel 02-2905-6277
Email/Email irb@mail.fju.edu.tw

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions National Taipei University of Nursing and Health Sciences (Taipei City, Taiwan)

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 08 10

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 10
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow
The study enrolled 11 participants signed informed consents, and one participant decided not to participate due to his personal reason for the difficulty about test schedule. Finally, ten subjects completed all three tests, and one participant did not comply the requirements of study control and was excluded from the study. Finally, nine participants were included in the data analyses. All subjects had reported no adverse responses during the trial.
有害事象/Adverse events
All participants had no reports of adverse responses during all trials.
評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2018 07 31
倫理委員会による承認日/Date of IRB
2018 07 31
登録・組入れ開始(予定)日/Anticipated trial start date
2018 07 31
フォロー終了(予定)日/Last follow-up date
2019 07 28
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 08 10
最終更新日/Last modified on
2019 10 05


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000038447
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038447

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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