UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032265 |
|---|---|
| Receipt number | R000036635 |
| Scientific Title | Efficacy of pedometer monitoring in patients undergoing subacute rehabilitation: a pilot study |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2023/04/20 19:57:24 |
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Basic information
Public title
Efficacy of pedometer monitoring in patients undergoing subacute rehabilitation: a pilot study
Acronym
Efficacy of pedometer monitoring in rehabilitation
Scientific Title
Efficacy of pedometer monitoring in patients undergoing subacute rehabilitation: a pilot study
Scientific Title:Acronym
Efficacy of pedometer monitoring in rehabilitation
Region
| Japan |
Condition
Condition
Patients admitted to a convalescent rehabilitation ward
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and feasibility of step counts monitoring and feedback for improving gait ability
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change rate of 6 minutes walking distance during intervention period
Key secondary outcomes
steps per day, 10 meter walking test,, chair stand test, Berg Balance Scale, Timed Up&Go Test, Falls Efficacy Scale-International
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
Participants wear a pedometer all day except bath time during study period. The participants are instructed to record steps per day by themselves in a diary, and are given feedbacks about step counts and goal settings weekly. They are encouraged to increase steps per day by 10% compared with the average step counts in the previous week.
All the participants undergo physical therapy and occupational therapy, 60 minutes per day each, 6 days a week throughout the study period.
Interventions/Control_2
Control group
Participants wear a pedometer all day except bath time during study period. For the control group, not the participants themselves but examiners record steps per day; and feedbacks about step counts are not given.
All the participants undergo physical therapy and occupational therapy, 60 minutes per day each, 6 days a week throughout the study period.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Consent to participate in the study
2. Functional Ambulation Category 3 (Dependent, Supervision) or more
3. Mini-Mental State Examination score 24 or more
Key exclusion criteria
1. Walking speed less than 0.4m/sec in 10 meter walking test
2. Unable to understand verbal instructions due to aphasia or cognitive dysfunctions
3. Contraindications for encouragement to walk
-Conditions that need rest, i.e. acute phase of vertebral compression fracture, uncontrolled pain due to musculoskeletal diseases
-Respiratory and/or circulatory dysfunction that need restriction of activity
-Other conditions that need restriction of activity
4. Other conditions which physiatrists consider inappropriate to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Otaka |
Organization
Kariya Toyota General Hospital
Division name
Department of Rehabilitation Medicine
Zip code
448-8505
Address
5-15 Sumiyoshi-cho, Kariya, Aichi Japan 448-8505
TEL
0566-21-2450
eyokohama93@gmail.com
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Otaka |
Organization
Kariya Toyota General Hospital
Division name
Department of Rehabilitation Medicine
Zip code
448-8505
Address
5-15 Sumiyoshi-cho, Kariya, Aichi Japan 448-8505
TEL
0566-21-2450
Homepage URL
eyokohama93@gmail.com
Sponsor or person
Institute
Kariya Toyota General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kariya Toyota General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kariya Toyota General Hospital research ethics committee
Address
5-15 Sumiyoshi-cho, Kariya, Aichi Japan 448-8505
Tel
0566-21-2450
KTGH.kouhou@toyota-kai.or.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
刈谷豊田総合病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
not available
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fresc.2023.1050638/full
Number of participants that the trial has enrolled
29
Results
Regarding feasibility outcomes, the data acquisition rate was 94.1% and the number of falls during the observation period was one in the feedback group. Regarding efficacy outcomes, change in 6MD was not significantly greater in the feedback group [mean (standard deviation): 79.1 (51.7) m] than in the no-feedback group [86.1 (65.4) m] (p = 0.774) and the other five secondary outcomes showed no between-group difference.
Results date posted
| 2023 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 29 participants were randomly assigned to the feedback group (n = 16) or the no-feedback group (n = 13).
The participants characteristics, including the primary disease, are shown in Table 1.
There were no significant differences in the demographic and disease characteristics and baseline assessments between the two groups.
Of these, two participants in the feedback group had missing outcome data due to the failure of the monitoring device. Two other participants, one in the feedback group and one in the no-feedback group, refused to continue receiving the allocated intervention. One participant withdrew because of ankle pain on the unaffected side.
https://www.frontiersin.org/files/Articles/1050638/fresc-04-1050638-HTML/image_m/fresc-04-1050638-t001.jpg
Participant flow
The flow diagram of the participants is shown in Figure 2.
https://www.frontiersin.org/files/Articles/1050638/fresc-04-1050638-HTML/image_m/fresc-04-1050638-g002.jpg
Adverse events
Regarding adverse events, the number of falls during the observational period was zero in the no-feedback group and one in the feedback group, which was calculated as 3.6 per 1,000 person-days fall rate. This fall rate was sufficiently small in comparison with the fall rate in Japanese rehabilitation wards reported previously, ranging from 4.6 (35) to 13.9 (36). No other adverse events were reported.
Outcome measures
The primary outcome was the change in the 6-minute walking distance (6MD) during the observational period, that is, from the day the participants were permitted to walk independently in a ward until the day before discharge. As secondary efficacy outcomes, blinded assessors performed a 10-meter walking test, a 30-second chair stand test (31) as a measure of lower muscle power, Berg Balance Scale (32) as a measure of balance (0: worst-56: best), and Timed Up and Go Test (33) to assess functional mobility. The number of steps per day recorded by the Fitbit device was also analyzed as a secondary efficacy outcome.
Regarding feasibility outcomes, two kinds of indicators were assessed. First, the pedometer data acquisition rate, which was calculated as the ratio of the number of days that pedometer data was obtained to the days of the whole observational period, was examined as an indicator of adherence. Secondly, the number of falls during the monitoring period was examined as an indicator of safety as increased activity may result in a greater risk of falling for these fall-prone populations.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 09 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036635
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