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 |
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)
日本語
PEERS trial
英語
PEERS Trial
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)
日本語
PEERS trial
英語
PEERS Trial
日本/Japan |
日本語
フレイルでない健常高齢者
英語
Elderly without frailty
成人/Adult |
悪性腫瘍以外/Others
いいえ/NO
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.
安全性・有効性/Safety,Efficacy
日本語
英語
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)
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
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
オープン/Open -no one is blinded
無治療対照/No treatment
はい/YES
いいえ/NO
施設を考慮していない/Institution is not considered as adjustment factor.
はい/YES
中央登録/Central registration
2
教育・カウンセリング・トレーニング/Educational,Counseling,Training
その他/Other |
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)
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)
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
65 | 歳/years-old | 以上/<= |
適用なし/Not applicable |
男女両方/Male and Female
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
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
100
日本語
名 | 幸治 |
ミドルネーム | |
姓 | 大庭 |
英語
名 | Koji |
ミドルネーム | |
姓 | Oba |
日本語
東京大学
英語
The University of Tokyo
日本語
情報学環
英語
Interfaculty Initiative in Information Studies
113-0033
日本語
東京都文京区本郷7-3-1
英語
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-5841-3519
oba@epistat.m.u-tokyo.ac.jp
日本語
名 | 泰広 |
ミドルネーム | |
姓 | 土田 |
英語
名 | Yasuhiro |
ミドルネーム | |
姓 | Tsuchida |
日本語
株式会社Moff
英語
Moff Corp.
日本語
Moff
英語
Moff
107-0062
日本語
東京都港区南青山3-3-6
英語
3-3-6, Minami-Aoyama, Minato-ku, Tokyo
03-4405-5216
info@moff.mobi
日本語
東京大学
英語
The University of Tokyo
日本語
日本語
日本語
英語
日本語
無し
英語
Moff Corp.
日本語
株式会社Moff
日本語
自己調達/Self funding
日本語
英語
日本語
神戸市
英語
Kobe City
日本語
英語
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
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
03-5841-5960
kenkyo@iii.u-tokyo.ac.jp
いいえ/NO
日本語
英語
日本語
英語
自宅(兵庫県)
2020 | 年 | 09 | 月 | 05 | 日 |
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03273-3
最終結果が公表されている/Published
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03273-3
70
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.
2022 | 年 | 09 | 月 | 02 | 日 |
日本語
英語
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.
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).
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.
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).
日本語
英語
日本語
英語
試験終了/Completed
2020 | 年 | 08 | 月 | 28 | 日 |
2020 | 年 | 08 | 月 | 30 | 日 |
2020 | 年 | 09 | 月 | 06 | 日 |
2020 | 年 | 12 | 月 | 31 | 日 |
2021 | 年 | 03 | 月 | 31 | 日 |
日本語
英語
2020 | 年 | 08 | 月 | 31 | 日 |
2022 | 年 | 09 | 月 | 02 | 日 |
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
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