UMIN-CTR Clinical Trial

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
Email	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
Email	kim-min-joon@ed.tmu.ac.jp

Sponsor
Institute	Tokyo Metropolitan University, Graduate School of Human Health Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044861