UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Effect and mechanism of different exercise prescriptions on metabolic syndrome

一般向け試験名略称/Acronym

日本語

英語
DEPMS

科学的試験名/Scientific Title

日本語

英語
Effect and mechanism of different exercise prescriptions on metabolic syndrome

科学的試験名略称/Scientific Title:Acronym

日本語

英語
DEPMS

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語

英語
Open public recruiting

疾患区分1/Classification by specialty

老年内科学/Geriatrics

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1/Narrative objectives1

日本語

英語
The study aims to explore the effectiveness and mechanisms of different exercise prescriptions for metabolic syndrome in the elderly, providing experimental research evidence for the development and clinical application of safe, efficient, personalized, and quantified exercise prescriptions tailored to the elderly population with metabolic syndrome.

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

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

主要アウトカム評価項目/Primary outcomes

日本語

英語
The primary outcome measures of this study include waist circumference, blood pressure, blood sugar, triglyceride, high-density lipoprotein cholesterol.

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
Blood indicators, Timed Up and Go Test (TUGT), Short Physical Performance Battery (SPPB), muscle mass, muscle strength, 4-meter walking speed, 6-minute walk distance, dietary nutrition and sleep status, physical activity levels, and changes in maximal oxygen uptake.

試験の種類/Study type

介入/Interventional

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

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

群数/No. of arms

5

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

その他/Other

介入1/Interventions/Control_1

日本語

英語
1) Moderate-intensity aerobic exercise group: 30 minutes of moderate-intensity continuous exercise under supervision using the equipment configured in the center, and the subjects wore a heart rate belt to monitor their heart rate during the exercise, exercising 3 times a week for a total of 12 weeks; Include 5 minutes of dynamic stretching and warm-up before and after exercise.
2) High-intensity interval aerobic exercise group: 30 minutes of high-intensity interval exercise under supervision were carried out with the equipment configured in the center, the subjects wore heart rate belts to monitor the heart rate during the exercise, and the high-intensity interval exercise program was 4 * 4 minutes, with a high-intensity interval of 3 minutes and a low-intensity recovery, and exercised 3 times a week for a total of 12 weeks; Include 5 minutes of dynamic stretching and warm-up before and after exercise.

介入2/Interventions/Control_2

日本語

英語
Moderate-intensity aerobic exercise group: 30 minutes of supervised moderate-intensity continuous exercise were performed in self-programmed aerobics, and the subjects wore heart rate belts to monitor their heart rate during exercise. Exercise 3 times a week for 12 weeks; Include 5 minutes of dynamic stretching and warm-up before and after exercise.

介入3/Interventions/Control_3

日本語

英語
High-intensity interval aerobic exercise group: self-programmed aerobic exercises, 30 minutes of high-intensity interval exercise under supervision, subjects wear heart rate bands to monitor heart rate during exercise, and high-intensity interval exercise program 4 * 4 minutes high-intensity interval 3 minutes low-intensity recovery. Exercise 3 times a week for 12 weeks; Include 5 minutes of dynamic stretching and warm-up before and after exercise.

介入4/Interventions/Control_4

日本語

英語
Resistance exercise group: Resistance training adopts Circular resistance training (CRT) mode, the upper body adopts 30-40% intensity of 1RM, and the lower body adopts 50-60% intensity of 1RM, each group of movements is repeated 15-20 times, all 7 movements are completed into a cycle, the interval between movements is 30s, the interval between cycles is 1min, a total of 2 cycles are done. Exercise 3 times a week for 12 weeks; Include 5 minutes of dynamic stretching and warm-up before and after exercise.

介入5/Interventions/Control_5

日本語

英語
Traditional exercise group: During the introduction period, the enrolled patients were trained in exercise prescription (Baduanjin, Taijiquan or other traditional exercises) for 2-3 weeks, 2-3 times a week, 1 hour each time, to ensure that the patients mastered the essentials of the movements. After the end of the introduction period, a 12-week observation period, 1-4 weeks of group exercise, 5-12 weeks of free exercise, during which the patient's exercise status was tracked by phone and WeChat. Exercise 3 times a week for 12 weeks; Include 5 minutes of dynamic stretching and warm-up before and after exercise.
Remark:

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

60

歳/years-old

より上/<

年齢（上限）/Age-upper limit

100

歳/years-old

以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
Those who meet the diagnostic criteria for metabolic syndrome
Sedentary behavior, at least 3 days per week, 30 minutes per day, with moderate-intensity physical activity for 3 months.
Subjects are willing to participate and can sign an informed consent form.

除外基準/Key exclusion criteria

日本語

英語
Those who have a history of critical illness such as cerebrovascular accident, malignant hypertension, myocardial infarction, heart failure, and diabetic ketoacidosis in the past six months.

目標参加者数/Target sample size

2000

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Qi
ミドルネーム
姓	Guo

所属組織/Organization

日本語

英語
Shanghai University of Medicine and Health Sciences

所属部署/Division name

日本語

英語
China

郵便番号/Zip code

201318

住所/Address

日本語

英語
279 Zhouzhu highway , Pudong New District, Shanghai

電話/TEL

15620467578

Email/Email

guoqijp@gmail.com

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Ming
ミドルネーム
姓	Lan

組織名/Organization

日本語

英語
Tianjin University of Traditional Chinese Medicine

部署名/Division name

日本語

英語
China

郵便番号/Zip code

301617

住所/Address

日本語

英語
10 Poyanghu Road, West Area of Tuanbo New Town, Jinghai District, Tianjin

電話/TEL

18950823975

試験のホームページURL/Homepage URL

Email/Email

lanming0100@163.com

機関名/Institute

日本語
その他

英語
Department of Rehabilitation Medicine, Shanghai University of Medicine and Health Sciences

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Non

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

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

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

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

日本語

英語

組織名/Organization

日本語

英語
Shanghai University of Medicine and Health Sciences

住所/Address

日本語

英語
279 Zhouzhu highway , Pudong New District, Shanghai

電話/Tel

15620467578

Email/Email

guoqijp@gmail.com

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

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

Shanghai University of Medicine and Health Sciences

一般公開日（本登録希望日）/Date of disclosure of the study information

2025

年

02

月

17

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

中間解析等の途中公開/Partially published

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

日本語

英語

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

日本語

英語

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

日本語

英語

参加者の流れ/Participant flow

日本語

英語

有害事象/Adverse events

日本語

英語

評価項目/Outcome measures

日本語

英語

個別症例データ共有計画/Plan to share IPD

日本語

英語

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

日本語

英語

試験進捗状況/Recruitment status

一般募集中/Open public recruiting

プロトコル確定日/Date of protocol fixation

2025

年

01

月

17

日

倫理委員会による承認日/Date of IRB

2025

年

02

月

17

日

登録・組入れ開始（予定）日/Anticipated trial start date

2025

年

01

月

17

日

フォロー終了(予定)日/Last follow-up date

2025

年

02

月

17

日

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

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2025

年

02

月

17

日

最終更新日/Last modified on

2025

年

02

月

17

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000065207

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065207