UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040156 |
|---|---|
| Receipt number | R000043402 |
| Scientific Title | Exploratory study on effect to flail prevention and behaviour change using ankle weight with sensor (power walk): A prospective phase 1 study |
| Date of disclosure of the study information | 2020/04/21 |
| Last modified on | 2022/10/17 12:05:50 |
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Basic information
Public title
Exploratory study on effect to flail prevention and behaviour change using ankle weight with sensor (power walk)
Acronym
Study on effect to flail prevention
Scientific Title
Exploratory study on effect to flail prevention and behaviour change using ankle weight with sensor (power walk): A prospective phase 1 study
Scientific Title:Acronym
Study on effect to flail prevention: A prospective phase 1 study
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to use a sensor-equipped Ankle-weight(AW) (named as Power Walk and abbreviated as PW), which is an original device with a sensor attached to the AW, to conduct a simple interview when charging the PW during the intervention period and accumulating sensor data. Factors related to behavioral changes in the non-intervention period (post-observation 12 weeks) and frailty and falls of the elderly between the group (feedback group) and the non-feedback group (post-observation group) will be compared before and after PW wearing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration (seconds) by single-leg standing test with open eyes before and after intervention (second and third measurement points) and after intervention and after non-intervention (third and fourth measurement points).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A group (feedback group) that uses a sensor built-in AW (named as Power Wolk: PW), which is an original device that attaches a sensor to the ankle weight (AW), to charge the PW during the intervention period and to have a simple interview when collecting sensor data. )
Interventions/Control_2
Non-feedback group (non-feedback group) during the non-intervention period (post-observation 12 weeks), behavioral changes and factors related to flail and falls in the elderly are compared and verified before and after PW wearing.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those who are able to communicate in Japanese, understand the plan for recruiting volunteers through an appeal to the community, companies, administrative staff, and residents of facilities, etc., and are able to generally comply with the prescribed interventions and cooperate in the measurement.
2) Score on the Motor Fitness Scale (MFS, Questionnaire: Document 2) is at least 60% out of 14 (11 points for men and 9 points for women: http://www.pbhealth.med.tohoku.ac.jp/node/455#Page).
3) Applicants must be able to respond appropriately to questionnaires and impact studies.
4) Ankle weights with sensors should be selected at your own risk at a slightly higher weight (2% of the body weight per foot, see reference 5), and you should be able to wear the ankle weights with sensors (the weight can be changed during the intervention period) and walk outside for at least 20 minutes once a day, at least 2 days a week (you can divide the weight into smaller portions until you get used to it). There is no upper limit, but those who are willing to wear the equipment at their own risk and without strain, and who are willing to come to each facility periodically (approximately every 10-14 days during the intervention period) to collect data and recharge at home.
5) To wear the activity meter during the study period, except at bedtime, and to come to each facility regularly to recharge and collect data (approximately every 40 to 45 days during the study period).
6) Accident/Incident Note/Calendar for wearing out of the office (record of wearing out of the office) (
Those who are willing to fill in the notes/calendars (hereafter abbreviated as notes/calendars), complete nutritional surveys before and after the study period, and complete questionnaires at the end of the study.
7) Those who understand the above and have signed the consent form.
Key exclusion criteria
1) Young people under the age of 50
2) If you may be pregnant or are pregnant.
3) People who are using muscle enhancers, male hormones or corticosteroids used for doping (topical topical use is not applicable).
4) If your MFS score is less than 60% out of 14 (Overall judgement is based on 11 points for males and 9 points for females: http://www.pbhealth.med.tohoku.ac.jp/node/455#Page)
5) Those who have spontaneous pain, exercise pain, or serious diseases of bone, muscle, joint, or cardiorespiratory system, as determined by the doctor based on the presence or absence of joint or muscle pain such as back pain and knee joint pain at the hearing.
6) Those who are unable to take MRI images due to metals in the body, etc. (only MRI images are excluded)
7) Other persons deemed inappropriate by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Akatsu |
Organization
Nagoya City University Graduate School of Medicine
Division name
Department of Community-based Medical Education
Zip code
467-8601
Address
Aza-Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya city
TEL
052-851-5511
akatu@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Akatsu |
Organization
Nagoya City University Graduate School of Medicine
Division name
Department of Community-based Medical Education
Zip code
467-8601
Address
Aza-Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya city
TEL
052-851-5511
Homepage URL
akatu@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research management center
Address
Aza-Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya city
Tel
052-851-5511
ctmc@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
74
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 06 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 06 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 14 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043402
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/10/14 | 20210816承認_計画書ver8.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
