UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the factor in conjunction with a change and the improvement of the lower limbs muscular strength by the different group repititive standing exercise intervention of the stance width in long-term care health facilites for the elderly woman
Title of the study (Brief title)	Examination of the factor in conjunction with a change and the improvement of the lower limbs muscular strength by the different group repititive standing exercise intervention of the stance width in long-term care health facilites for the elderly woman
Region	Japan

Condition
Condition	orthopedic diseases, neurosurgical diseases, internal disorders, geriatric syndrome
Classification by specialty	Medicine in general Surgery in general Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study conducted a randomized crossover comparative trial on a user of a female elderly who has been in long-term care for geriatrics and underwent massive closed leg repetitive standing exercise and group open leg repeated erecting movements with different stance widths over 16 weeks each of these isometric lower limb muscular strengths, this time knee extension muscle strength: quadriceps muscle (KE), knee flexion muscle strength: hamstrings (KF), hip external rotation muscle strength : external rotation muscle group (ER), hip internal rotation muscle strength: internal rotation muscle group (IR) will be compared and examined. We aim to examine the physical factors, fundamental movement ability factors, ADL factors of the group with the most improved muscular strength among the two types of intervention methods, and confirm the adaptation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Isometric knee extension muscle force, isometric knee flexion muscle force, isometric hip external rotation muscle force, isometric hip internal rotation muscle force
Key secondary outcomes	age, disease,onset,presence or absence of motor paralysis (BRS), height, weight, BMI, grip strength, standing frequency, Mini-mental state examination (MMSE), basic movement ability (BMS), daily of living activity ability (FIM)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	METHODS: A group open leg repetitive standing exercise Duration: 16 weeks Frequency: twice a week Number of times: 32 times
Interventions/Control_2	METHODS: A group closed leg repetitive standing exercise Duration: 16 weeks Frequency: twice a week Number of times: 32 times
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	75 years-old <=
Age-upper limit	100 years-old >
Gender	Female
Key inclusion criteria	1 Possible to hold the end sitting position by handrail 2 Standing motion from the chair is possible 3 Open legs and closed legs can be used during the standing motion
Key exclusion criteria	1 I can not understand verbal instruction2 exercise therapy withdrawal standard falls under 3 There is pain when exercising with arthritis 4 There is severe motor paralysis 5 There is progressive disease 6 There are severe knee extravasation / varus 7 short term intensive rehabilitation is applicable 8 Exercise therapy for this study is easy 9 We can not obtain research cooperation 10 Judge that the research manager is inappropriate as the subject
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshitsugu Fujii
Organization	Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital affiliated long-term care geriatric health facility
Division name	Long-Term Care Health Facility Departmen
Address	1-1 Kodacyou, Shunan-shi, Yamaguchi Prefecture
TEL	0834-28-8686
Email	tokuvr22@flute.ocn.ne.jp

Public contact
Name of contact person	Yoshitsugu Fujii
Organization	Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central
Division name	Long-Term Care Health Facility Departmen
Address	1-1 Kodacyou, Shunan-shi, Yamaguchi Prefecture
TEL	0834-28-8686
Homepage URL
Email	tokuvr22@flute.ocn.ne.jp

Sponsor
Institute	Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital
Institute
Department

Funding Source
Organization	Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	K307-20180412
Org. issuing International ID_1	Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	独立行政法人地域医療機能推進機構徳山中央病院附属介護老人保健施設

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 06 Month 06 Day
Last follow-up date	2019 Year 01 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 17 Day
Last modified on	2019 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036771