UMIN-CTR 臨床試験登録情報の閲覧

UMIN試験ID UMIN000041616
受付番号 R000047504
科学的試験名 在宅高齢者のフレイル予防を目的とした遠隔での運動介入研究
一般公開日(本登録希望日) 2020/09/05
最終更新日 2022/09/02 10:12:45

※ 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

日本語
在宅高齢者のフレイル予防を目的とした遠隔での運動介入研究


英語
Prevention of frailty in Elderly by home-based Exercise intervention with Remote Supervision (PEERS trial)

一般向け試験名略称/Acronym

日本語
PEERS trial


英語
PEERS Trial

科学的試験名/Scientific Title

日本語
在宅高齢者のフレイル予防を目的とした遠隔での運動介入研究


英語
Prevention of frailty in Elderly by home-based Exercise intervention with Remote Supervision (PEERS trial)

科学的試験名略称/Scientific Title:Acronym

日本語
PEERS trial


英語
PEERS Trial

試験実施地域/Region

日本/Japan


対象疾患/Condition

対象疾患名/Condition

日本語
フレイルでない健常高齢者


英語
Elderly without frailty

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

日本語
Moff社が開発したモーションセンサを身に着けながら介護予防運動プログラムを実施するアプリケーション「モフトレパーソナル」を用いて、高齢者(65歳以上)を対象に、遠隔で各自が自宅で参加できる介護予防運動プログラムの有効性を評価することを目的とする。


英語
The purpose of this study is to evaluate the effectiveness of a preventive exercise program for elderly people (65 years of age and older) that they can participate in remotely at home using Moff's mobile application that allows them to perform a preventive exercise program for frailty prevention while wearing motion sensors developed by Moff.

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



評価/Assessment

主要アウトカム評価項目/Primary outcomes

日本語
30秒椅子立ち上がりテスト(CS-30)


英語
30-second chair stand test(CS-30)

副次アウトカム評価項目/Key secondary outcomes

日本語
Time Up & Goテスト (TUG)、開眼片脚立ちテスト、自覚的効果(体力、腰痛/ひざ痛、気持ち、交流、家族会話等)、安全性


英語
Time Upe & Go test (TUG), one-leg standing duration with vision, self-reported efect (physical fitness, back/knee pain, feelings, interactions, family conversations, etc.), safety


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

はい/YES

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

はい/YES

割付コードを知る方法/Concealment

中央登録/Central registration


介入/Intervention

群数/No. of arms

2

介入の目的/Purpose of intervention

教育・カウンセリング・トレーニング/Educational,Counseling,Training

介入の種類/Type of intervention

その他/Other

介入1/Interventions/Control_1

日本語
運動集中コース(運動を週3回継続的に実施し、身体機能の向上を目指すコース)


英語
Intensive exercise course (a course designed to improve physical function by exercising three times a week on a continuous basis)

介入2/Interventions/Control_2

日本語
健康学習コース(運動と健康に関する学習を週3回組合せて行い、健康維持を目指すコース)


英語
Healthy Learning Course (a course that combines exercise and health-related learning three times a week to help maintaining their health)

介入3/Interventions/Control_3

日本語


英語

介入4/Interventions/Control_4

日本語


英語

介入5/Interventions/Control_5

日本語


英語

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


適格性/Eligibility

年齢(下限)/Age-lower limit

65 歳/years-old 以上/<=

年齢(上限)/Age-upper limit


適用なし/Not applicable

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
1) 神戸市在住の満65歳以上の方
2) いきいき100歳体操(座位・立位)を自宅で安全に実施できる方
3) iPhoneまたはiPadをお持ちの方


英語
1) Residents of Kobe City who are 65 years of age or older
2) Those who can safely perform the "Lively 100 year old exercise" (sitting and standing) at home.
3) iPhone or iPad owners

除外基準/Key exclusion criteria

日本語
1) 簡易フレイルインデックスに基づいて、フレイルと判定された方
2) 転倒リスク基準に基づいて、転倒リスクが高いと判断された方


英語
1) Frail elderly based on the frailty screening index
2) High-risk elderly based on the fall risk criteria

目標参加者数/Target sample size

100


責任研究者/Research contact person

責任研究者/Name of lead principal investigator

日本語
幸治
ミドルネーム
大庭


英語
Koji
ミドルネーム
Oba

所属組織/Organization

日本語
東京大学


英語
The University of Tokyo

所属部署/Division name

日本語
情報学環


英語
Interfaculty Initiative in Information Studies

郵便番号/Zip code

113-0033

住所/Address

日本語
東京都文京区本郷7-3-1


英語
7-3-1, Hongo, Bunkyo-ku, Tokyo

電話/TEL

03-5841-3519

Email/Email

oba@epistat.m.u-tokyo.ac.jp


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

日本語
泰広
ミドルネーム
土田


英語
Yasuhiro
ミドルネーム
Tsuchida

組織名/Organization

日本語
株式会社Moff


英語
Moff Corp.

部署名/Division name

日本語
Moff


英語
Moff

郵便番号/Zip code

107-0062

住所/Address

日本語
東京都港区南青山3-3-6


英語
3-3-6, Minami-Aoyama, Minato-ku, Tokyo

電話/TEL

03-4405-5216

試験のホームページURL/Homepage URL


Email/Email

info@moff.mobi


実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
東京大学


英語
The University of Tokyo

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


研究費提供組織/Funding Source

機関名/Organization

日本語
無し


英語
Moff Corp.

機関名/Organization
(機関選択不可の場合)

日本語
株式会社Moff


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


その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語
神戸市


英語
Kobe City

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

日本語


英語


IRB等連絡先(公開)/IRB Contact (For public release)

組織名/Organization

日本語
東京大学情報学環・学際情報学府 研究協力チーム


英語
Interfaculty Initiative in Information Studies, The University of Tokyo

住所/Address

日本語
113-0033 東京都文京区本郷7-3-1


英語
7-3-1, Bunkyo-ku, Hongo, Tokyo

電話/Tel

03-5841-5960

Email/Email

kenkyo@iii.u-tokyo.ac.jp


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

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/Institutions

試験実施施設名称/Institutions

自宅(兵庫県)


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 09 05


関連情報/Related information

プロトコル掲載URL/URL releasing protocol

https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03273-3

試験結果の公開状況/Publication of results

最終結果が公表されている/Published


結果/Result

結果掲載URL/URL related to results and publications

https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03273-3

組み入れ参加者数/Number of participants that the trial has enrolled

70

主な結果/Results

日本語
After 3 months of intervention, CS-30 scores and other physical function improved in both groups. Difference in the 3-month CS-30 scores between two programs was found to be 0.08 (95% confidence interval: -2.64, 2.79; p = 0.955), which was not statistically significant. No harmful incidents, such as falls, occurred in either group.


英語
After 3 months of intervention, CS-30 scores and other physical function improved in both groups. Difference in the 3-month CS-30 scores between two programs was found to be 0.08 (95% confidence interval: -2.64, 2.79; p = 0.955), which was not statistically significant. No harmful incidents, such as falls, occurred in either group.

主な結果入力日/Results date posted

2022 09 02

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
Ultimately, 70 participants were enrolled and allocated into the two groups, with the Exercise-Intensive and Light-load exercise programs comprising 36 and 34 participants, respectively. Table 2 summarizes the participants’ characteristics at baseline according to their assigned program. Accordingly, 53% of the participants were male, with a mean age of 69 years. Although both groups were found to have comparable characteristics, there was a slight difference in the distribution of the Brief Frailty Index values. Notably, 50% of participants in the Exercise-Intensive program had a score of 0, whereas only 29% of those in the Light-load exercise program had the same score. The mean baseline scores for the CS-30 were 16.83 and 18.06 in the Exercise-Intensive and Light-load exercise programs, respectively. SOLEO test scores were considerably skewed, with several participants in both groups scoring the maximum of 120 s.


英語
Ultimately, 70 participants were enrolled and allocated into the two groups, with the Exercise-Intensive and Light-load exercise programs comprising 36 and 34 participants, respectively. Table 2 summarizes the participants' characteristics at baseline according to their assigned program. Accordingly, 53% of the participants were male, with a mean age of 69 years. Although both groups were found to have comparable characteristics, there was a slight difference in the distribution of the Brief Frailty Index values. Notably, 50% of participants in the Exercise-Intensive program had a score of 0, whereas only 29% of those in the Light-load exercise program had the same score. The mean baseline scores for the CS-30 were 16.83 and 18.06 in the Exercise-Intensive and Light-load exercise programs, respectively. SOLEO test scores were considerably skewed, with several participants in both groups scoring the maximum of 120 s.

参加者の流れ/Participant flow

日本語
The diagram includes the breakdown of the number of people who participated/did not participate in the intervention, the number of people in whom measurements were/were not obtained after 3 months, and the number of people included/excluded from analyses (all were included despite some missing data).


英語
The diagram includes the breakdown of the number of people who participated/did not participate in the intervention, the number of people in whom measurements were/were not obtained after 3 months, and the number of people included/excluded from analyses (all were included despite some missing data).

有害事象/Adverse events

日本語
No adverse events, such as falls, occurred in either of the programs.


英語
No adverse events, such as falls, occurred in either of the programs.

評価項目/Outcome measures

日本語
Figure 5 shows the crude changes in the mean (SD) results of the CS-30, TUG, and SOLEO tests for each month. A clear improvement in CS-30 and TUG test results was observed for both programs. Although the SOLEO test results also improved, the improvement leveled off given that the test had an upper limit of 120s. Table 3 shows the between-group differences (Exercise-Intensive program score - Light-load exercise program score) in MMRM estimates for the least squares means of the three tests. Participants in the Exercise-Intensive and Lightload exercise programs had an estimated least square mean for the 3-month CS-30 score of 27.30 (95% CI: 25.43 - 29.17) and 27.22 (95% CI: 25.27 - 29.18), respectively. The change in the CS-30 score after 3 months was 9.89 and 9.81 following the Exercise-Intensive and Light-load exercise programs, respectively. Therefore, the primary outcome (i.e., the 3-month between-group difference in scores) was 0.08 (95% CI: - 2.64 - 2.79), which was not statistically significant (p = 0.955). Similarly, no significant differences in secondary endpoints were found (Table 3). Subgroup analysis based on age, sex, and baseline CS-30 scores showed that the difference in the CS-30 scores after 3 months between the Exercise-Intensive and Light-load exercise programs was consistent across the prespecified subgroups (Table 4). Participation compliance differed between programs (Fig. 3). The crude mean change in the CS-30 score after 3 months was 12.55 (6.14) among compliers (N = 11) and 9.39 (6.25) among non-compliers (N = 18) in the Exercise-Intensive program. Similarly, the crude mean change in the CS-30 score after 3 months was 10.65 (4.92) among compliers (N = 23) and 6.00 (6.35) among noncompliers (N = 6) in the Light-load exercise program. Compliers exhibited a greater change in the CS-30 scores after 3 months than non-compliers in both the programs (p = 0.014 and p = 0.017, respectively). However, the complier-averaged treatment effect, defined as the average causal effect of the program on those who complied with their assignments, was 1.44 (95% CI: -2.33 - 5.21), without a significant difference between the programs (p = 0.454).


英語
Figure 5 shows the crude changes in the mean (SD) results of the CS-30, TUG, and SOLEO tests for each month. A clear improvement in CS-30 and TUG test results was observed for both programs. Although the SOLEO test results also improved, the improvement leveled off given that the test had an upper limit of 120s. Table 3 shows the between-group differences (Exercise-Intensive program score - Light-load exercise program score) in MMRM estimates for the least squares means of the three tests. Participants in the Exercise-Intensive and Lightload exercise programs had an estimated least square mean for the 3-month CS-30 score of 27.30 (95% CI: 25.43 - 29.17) and 27.22 (95% CI: 25.27 - 29.18), respectively. The change in the CS-30 score after 3 months was 9.89 and 9.81 following the Exercise-Intensive and Light-load exercise programs, respectively. Therefore, the primary outcome (i.e., the 3-month between-group difference in scores) was 0.08 (95% CI: - 2.64 - 2.79), which was not statistically significant (p = 0.955). Similarly, no significant differences in secondary endpoints were found (Table 3). Subgroup analysis based on age, sex, and baseline CS-30 scores showed that the difference in the CS-30 scores after 3 months between the Exercise-Intensive and Light-load exercise programs was consistent across the prespecified subgroups (Table 4). Participation compliance differed between programs (Fig. 3). The crude mean change in the CS-30 score after 3 months was 12.55 (6.14) among compliers (N = 11) and 9.39 (6.25) among non-compliers (N = 18) in the Exercise-Intensive program. Similarly, the crude mean change in the CS-30 score after 3 months was 10.65 (4.92) among compliers (N = 23) and 6.00 (6.35) among noncompliers (N = 6) in the Light-load exercise program. Compliers exhibited a greater change in the CS-30 scores after 3 months than non-compliers in both the programs (p = 0.014 and p = 0.017, respectively). However, the complier-averaged treatment effect, defined as the average causal effect of the program on those who complied with their assignments, was 1.44 (95% CI: -2.33 - 5.21), without a significant difference between the programs (p = 0.454).

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/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

2020 08 28

倫理委員会による承認日/Date of IRB

2020 08 30

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

2020 09 06

フォロー終了(予定)日/Last follow-up date

2020 12 31

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

2021 03 31


その他/Other

その他関連情報/Other related information

日本語


英語


管理情報/Management information

登録日時/Registered date

2020 08 31

最終更新日/Last modified on

2022 09 02



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=R000047504


英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047504


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