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利用者名:
UMIN ID:

試験進捗状況 限定募集中/Enrolling by invitation
UMIN試験ID UMIN000039519
受付番号 R000045070
科学的試験名
一般公開日(本登録希望日) 2020/02/18
最終更新日 2020/03/06

※ 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
Effect of combined training and detraining on type 2 diabetic women with depression
一般向け試験名略称/Acronym
Effect of combined training and detraining on type 2 diabetic women with depression
科学的試験名/Scientific Title
Effect of combined training and detraining on basal BDNF levels and depression index in type 2 diabetic women with depression
科学的試験名略称/Scientific Title:Acronym
Effect of combined training and detraining on basal BDNF levels and depression index in type 2 diabetic women with depression
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
type 2 diabetic women with depression
疾患区分1/Classification by specialty
精神神経科学/Psychiatry 手術医学/Operative medicine
リハビリテーション医学/Rehabilitation medicine
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
Overall purpose:The effect of combined training and detraining on basal BDNF levels and depression index in type 2 diabetic women with depression
Partial Goals:
The effect of combined training and detraining on Beck test score in type 2 diabetic women with depression
Effects of combined training and detraining on basal BDNF levels in type 2 diabetic women with depression
The effect of combined training and detraining on fat percentage in type 2 diabetic women with depression
Correlation between BDNF and depression in type 2 diabetic women with depression
The effect of combined training and detraining on basal insulin levels in type 2 diabetic women with depression
Effects of combined training and detraining on fasting blood glucose levels in type 2 diabetic women with depression
The effect of combined training and detraining on Oxford Happiness questionnaire scores in type 2 diabetic women with depression
The effect of combined training and detraining on Spielberg Anger Questionnaire scores in type 2 diabetic women with depression
The effect of combined training and detraining on Pennsylvania Concerns Questionnaire scores
in type 2 diabetic women with depression
The effect of combined training and detraining on Ahvaz Cognitive Hardiness Questionnaire scores
in type 2 diabetic women with depression
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
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
basal BDNF levels(pre test,post test)
Beck test score(pre test,post test)
fat percentage(pre test,post test)
basal insulin levels(pre test,post test)
fasting blood glucose levels(pre test,post test)
Oxford Happiness test score(pre test,post test)
Spielberg Anger test score(pre test,post test)
Pennsylvania Concerns test score(pre test,post test)
Ahvaz Cognitive Hardiness test score(pre test,post test)
副次アウトカム評価項目/Key secondary outcomes


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 並行群間比較/Parallel
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 オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
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 2
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1
Moderate intensity cimbined training (50-70% maximal heart rate reserve (HRR) and 50-70% 1 repetition maximom (1RM)), three times a week, for 12 weeks and each session 60 minutes.
Each session consists of 15 minutes of warm-up, 20 minutes of aerobic exercise (walking and running on the treadmill) and resistance training (whole body exercises including: Incline Bench Press, shoulder press, wide-grip lat pulldown, leg press, leg extensions, Lying Leg Curls , biceps and triceps pushdown,crunch) are circular, 12 repetitions, 3 rounds, with a 2-3 minute break between rounds and 10 minutes of stretching exercises to cool down.
介入2/Interventions/Control_2
no treatment. Continue their former lifestyle
介入3/Interventions/Control_3

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
50 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
75 歳/years-old 以下/>=
性別/Gender 女/Female
選択基準/Key inclusion criteria
1) BMI> 25
2) Menopause
3) No skeletal disease
4) Diabetes history of at least 4 years
5) Diagnosis of moderate depression by Beck test (score above 20)
6) blood pressure 160 to 95 mm Hg (maximum)
7) Age of menopause to 75 years
8) sedentary lifestyle for at least 6 months
9) glycemic control drugs
10) no metabolic conditions other than type 2 diabetes
11) fasting blood sugar at least 126
除外基準/Key exclusion criteria
1) Insulin therapy
2) Infectious disease
3) Skeletal disease
4) 3 sessions of no training
5) Malignant or known dementia
6) Metabolic conditions other than T2DM
目標参加者数/Target sample size 32

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

ミドルネーム

Nayereh
ミドルネーム
Kiani Shahvandi
所属組織/Organization
Sahrood University of Technology
所属部署/Division name
Sport Science,Sport physiology
郵便番号/Zip code 3619995161
住所/Address
Shahrood,Seventh Tir Square,Shahrood University of Technology
電話/TEL 00989364747539
Email/Email elina.kiani@shahroodut.ac.ir

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

Nayereh
ミドルネーム
Kiani Shahvandi
組織名/Organization
Shahrood University of Technology
部署名/Division name
Sport Science,Sport physiology
郵便番号/Zip code 3619995161
住所/Address
Shahrood,Seventh Tir Square,Shahrood University of Technology
電話/TEL 00989364747539
試験のホームページURL/Homepage URL
Email/Email elina.kiani@shahroodut.ac.ir

実施責任組織/Sponsor
機関名/Institute その他 Shahrood University of Technology
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 Shahrood University of Technology
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
Shahrood University of Technology
住所/Address
Shahrood,Seventh Tir Square,Shahrood University of Technology
電話/Tel 00982332392204
Email/Email elina.kiani@shahroodut.ac.ir

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

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
2020 02 18

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
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

有害事象/Adverse events

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 限定募集中/Enrolling by invitation
プロトコル確定日/Date of protocol fixation
2020 02 20
倫理委員会による承認日/Date of IRB
2019 12 07
登録・組入れ開始(予定)日/Anticipated trial start date
2020 02 27
フォロー終了(予定)日/Last follow-up date
2020 07 02
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
2020 02 18
最終更新日/Last modified on
2020 03 06


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=R000045070
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045070

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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