UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032292
Receipt number R000036771
Scientific 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
Date of disclosure of the study information 2018/05/01
Last modified on 2019/01/18 20:36:18

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Basic information

Public 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

Acronym

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

Scientific 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

Scientific Title:Acronym

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

1st name
Middle name
Last name 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

Zip code


Address

1-1 Kodacyou, Shunan-shi, Yamaguchi Prefecture

TEL

0834-28-8686

Email

tokuvr22@flute.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshitsugu Fujii

Organization

Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central

Division name

Long-Term Care Health Facility Departmen

Zip code


Address

1-1 Kodacyou, Shunan-shi, Yamaguchi Prefecture

TEL

0834-28-8686

Homepage URL


Email

tokuvr22@flute.ocn.ne.jp


Sponsor or person

Institute

Incorporated Administrative Agency Regional Medical Function Promotion Organization Tokuyama Central Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036771


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name