UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040156
Receipt No. 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 2021/06/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email akatu@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medicine
Institute
Department

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
Email 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 No longer recruiting
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 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 14 Day
Last modified on
2021 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.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


Contact us.