| 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 |
|
UMIN-CTR Clinical Trial