UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035761 |
|---|---|
| Receipt number | R000040725 |
| Scientific Title | Stand up from and sit down to floor in healthy young and elderly people |
| Date of disclosure of the study information | 2019/02/04 |
| Last modified on | 2023/05/31 08:53:43 |
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Basic information
Public title
Stand up from and sit down to floor in healthy young and elderly people
Acronym
Stand up from and sit down to floor
Scientific Title
Stand up from and sit down to floor in healthy young and elderly people
Scientific Title:Acronym
Stand up from and sit down to floor
Region
| Japan |
Condition
Condition
healnthy ederly and young people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives were to examine the effect of differences in the sheat height and the floor property on kinematics and kinetics of sit to stand up from and sit down to the floor.
Basic objectives2
Others
Basic objectives -Others
The objectives were to examine the effect of differences in aging on kinematics and kinetics of sit to stand up from and sit down to the floor.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
kinematic and kinetic parameters
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy young and elderly people
(2) Healthy young people over twenty years old and less than fourty years old
(3) Healthy elderly people over sixty five years old
(4) Men and women
(5) The score of MMSE is over 24 points.
Key exclusion criteria
(1) having pain at a joint in a lower limb
(2) having had surgery in lower limb
(3) having neurologic and orthopaedic deseases
(4) having major visual deficit
(5) having major respiratory and circulatory deseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shin-Ichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8575
Address
2-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan
TEL
0227177338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sekiguchi |
Organization
Tohoku University Hospital
Division name
Department of Rehabilitation
Zip code
980-8575
Address
1-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan
TEL
0227177677
Homepage URL
yusuke.sekiguchi.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
TOTO LTD.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review board of the Tohoku University School of Medicine
Address
2-1,Seiryo-machi,Aoba-Ku,Sendai,Miyagi,Japan
Tel
0227178007
med-kenkyo@grp.tohoku.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
| 2019 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040725
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jbiomech.2022.110996
Number of participants that the trial has enrolled
31
Results
The depth of the squatting motion was significantly shallower in the elderly than in the young (p < 0.05). Furthermore, in the squatting motion, the elderly had smaller ankle dorsiflexion and knee flexion angles, larger trunk flexion angles, and larger forward displacement of the whole body center of mass. In addition, for kinematic variables, it was shown that at the timing of the maximum support moment during the squatting motion, the contribution of the hip extension moment was large.
Results date posted
| 2023 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
20 elderly people and 20 young people participated in each group. One elderly person was excluded due to measurement problems due to a lot of noise in the reflex marker trajectory during the experimental task. Two elderly people were excluded because their Mini-Mental State Exam was less than 24 points. One young person and five elderly people were excluded from analysis because they could not successfully complete the exercise task. As a result, this study used measurement data from 12 elderly people and 19 young people for analysis.
Participant flow
20 elderly people and 20 young people participated in each group. One elderly person was excluded due to measurement problems due to a lot of noise in the reflex marker trajectory during the experimental task. Two elderly people were excluded because their Mini-Mental State Exam was less than 24 points. One young person and five elderly people were excluded from analysis because they could not successfully complete the exercise task. As a result, this study used measurement data from 12 elderly people and 19 young people for analysis.
Adverse events
None.
Outcome measures
Kinematic and kinetic indicators of lower limbs and trunk during squatting task
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measure sit to stand and stand to sit using three dimensional motion analysis system. Subjects perform sit to stand and stand to sit at four seat heights (60cm, 40cm, 20cm, 0cm) in two floor conditions (scabrous floor and no scabrous floor). Subjects sit to stand and stand to sit five times at a seat height in a floor condition.
Management information
Registered date
| 2019 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040725
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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