UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041616 |
|---|---|
| Receipt number | R000047504 |
| Scientific Title | Prevention of frailty in Elderly by home-based Exercise intervention with Remote Supervision (PEERS trial) |
| Date of disclosure of the study information | 2020/09/05 |
| Last modified on | 2022/09/02 10:12:45 |
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Basic information
Public title
Prevention of frailty in Elderly by home-based Exercise intervention with Remote Supervision (PEERS trial)
Acronym
PEERS Trial
Scientific Title
Prevention of frailty in Elderly by home-based Exercise intervention with Remote Supervision (PEERS trial)
Scientific Title:Acronym
PEERS Trial
Region
| Japan |
Condition
Condition
Elderly without frailty
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-second chair stand test(CS-30)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Intensive exercise course (a course designed to improve physical function by exercising three times a week on a continuous basis)
Interventions/Control_2
Healthy Learning Course (a course that combines exercise and health-related learning three times a week to help maintaining their health)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
1) Frail elderly based on the frailty screening index
2) High-risk elderly based on the fall risk criteria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Oba |
Organization
The University of Tokyo
Division name
Interfaculty Initiative in Information Studies
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3519
oba@epistat.m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tsuchida |
Organization
Moff Corp.
Division name
Moff
Zip code
107-0062
Address
3-3-6, Minami-Aoyama, Minato-ku, Tokyo
TEL
03-4405-5216
Homepage URL
info@moff.mobi
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Moff Corp.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe City
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Interfaculty Initiative in Information Studies, The University of Tokyo
Address
7-3-1, Bunkyo-ku, Hongo, Tokyo
Tel
03-5841-5960
kenkyo@iii.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
自宅（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03273-3
Publication of results
Published
Result
URL related to results and publications
https://bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03273-3
Number of participants that the trial has enrolled
70
Results
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.
Results date posted
| 2022 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
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).
Adverse events
No adverse events, such as falls, occurred in either of the programs.
Outcome measures
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).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047504
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