UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039379 |
|---|---|
| Receipt number | R000044861 |
| Scientific Title | Effect of feedback-based exercise for the stability of the elderly |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/02/03 17:04:25 |
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Basic information
Public title
Effect of feedback-based exercise for the stability of the elderly
Acronym
Effect of feedback-based exercise for the stability of the elderly
Scientific Title
Effect of feedback-based exercise for the stability of the elderly
Scientific Title:Acronym
Effect of feedback-based exercise for the stability of the elderly
Region
| Japan |
Condition
Condition
the community elderly
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarification of the effects of exercise using feedback for healthy elderly people living in a community on the range of motion of the upper extremity and the muscle strength and activities of daily living and the stability of the trunk
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Before and after interventions muscle strength, shoulder range of motion, Assessment of activities of daily living of upper limb.
assessment of trunk function
Measure evaluation items once four weeks after intervention, and once eight weeks after intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A total of 32 men and women in their 70s to 80s who have no problem with their upper extremity functions in the area are targeted, and the respective movements are maintained for 15 seconds to take a rest for about 30 seconds.Repeat these five times.
An evaluation method for more effective exercise intervention is established by evaluating muscle strength, shoulder joint movement range, upper extremity ADL (activities of daily living) and trunk function before and after performing.
A band is used to perform exercise intervention.
Intervention period is 8 weeks.
Interventions/Control_2
An evaluation method for more effective exercise intervention is established by evaluating muscle strength, shoulder joint movement range, upper extremity ADL (activities of daily living) and trunk function before and after performing.
Do exercise intervention without using a band.
(The method of exercise is the same as intervention 1).
Intervention period is 8 weeks.
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
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
An elderly person aged 70 or over and under 90
Key exclusion criteria
Persons who have a history of operations or other diseases other than orthopedic diseases
Activity of Daily Living; ADL) Restricted Person
A person who has problems with the cognitive function and is unable to memorize exercise or who may find it difficult to continue exercise.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | minjoon |
| Middle name | |
| Last name | kim |
Organization
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Division name
Physical therapy
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku,tokyo
TEL
03-3819-1211
kim-min-joon@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | minjoon |
| Middle name | |
| Last name | kim |
Organization
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Division name
Physical therapy
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
kim-min-joon@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan University, Graduate School of Human Health Sciences
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
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Address
7-2-10 Higashiogu, Arakawa-ku, Tokyo
Tel
03-3819-1211
kim-min-joon@ed.tmu.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 | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044861
