UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020888
Receipt number R000024100
Scientific Title Effects of closed kinetic chain training by ascending the step on locomotive syndrome, locomotive function, muscle strength in the lower extremities, balance, difficulty with stair ambulation, and fear of falling in community-dwelling middle-aged and elderly adults.
Date of disclosure of the study information 2016/02/05
Last modified on 2016/02/15 18:38:32

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Basic information

Public title

Effects of closed kinetic chain training by ascending the step on locomotive syndrome, locomotive function, muscle strength in the lower extremities, balance, difficulty with stair ambulation, and fear of falling in community-dwelling middle-aged and elderly adults.

Acronym

Effects of closed kinetic chain training by ascending the step.

Scientific Title

Effects of closed kinetic chain training by ascending the step on locomotive syndrome, locomotive function, muscle strength in the lower extremities, balance, difficulty with stair ambulation, and fear of falling in community-dwelling middle-aged and elderly adults.

Scientific Title:Acronym

Effects of closed kinetic chain training by ascending the step.

Region

Japan


Condition

Condition

Community-dwelling middle-aged and elderly adults

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine effects of closed kinetic chain training by ascending the step on locomotive syndrome, locomotive function, muscle strength in the lower extremities, balance, difficulty with stair ambulation, and fear of falling in community-dwelling middle-aged and elderly adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Locomotive syndrome, locomotive function, difficulty with stair ambulation, and fear of falling at 3 month

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

(Interventions)
The subjects perform warm-up, muscle strength training in the lower extremities, balance training, top leg training during ascending the step by 60 minutes, twice a week for 12 weeks.

Interventions/Control_2

(Controls)
The subjects perform warm-up, muscle strength training in the lower extremities, balance training, bottom leg training during ascending the step by 60 minutes, twice a week for 12 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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

・The subjects who can walk and ascend the step independently.
・The subjects who can understand explanation of the study and instruction of training.

Key exclusion criteria

・The subjects having severe orthopedic, neurological, respiratory or circulatory disorders.
・The subjects having lower extremity pain during ascending the step.
・The subjects having severe dementia.
・The subjects having previous surgery of lower extremity.
・The subjects having regular rehabilitation.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Ichihashi

Organization

Human Health Sciences, Graduate School of Medicine, Kyoto University

Division name

Department of Development and Rehabilitation of Motor Function

Zip code


Address

606-8507 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3951

Email

ichihashi.noriaki.5z@kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuhiro Masaki

Organization

Human Health Sciences, Graduate School of Medicine, Kyoto University

Division name

Department of Development and Rehabilitation of Motor Function

Zip code


Address

606-8507 53 Kawahara-cho Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3935

Homepage URL


Email

masaki.mitsuhiro.27w@st.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Development and Rehabilitation of Motor Function,
Human Health Sciences, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Kyoritsu Denshi Kogyo

Organization

Division

Category of Funding Organization

Profit organization

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

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

2016 Year 02 Month 05 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

2016 Year 02 Month 05 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 04 Day

Last modified on

2016 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024100


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name