UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017056
Receipt number R000019779
Scientific Title Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial
Date of disclosure of the study information 2015/04/06
Last modified on 2016/06/06 20:02:49

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Basic information

Public title

Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial

Acronym

Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial

Scientific Title

Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial

Scientific Title:Acronym

Effect of low load strength training of the quadriceps femoris on muscle function and functional capacity in older adult: A randomized controlled trial

Region

Japan


Condition

Condition

Older adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to present the effect of twenty- weeks low load strength training of the quadriceps femoris on muscle function and functional capacity in older adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle thickness and echo intensity of the quadriceps femoris muscle
Maximal isometric strength of the knee extensor muscle

Key secondary outcomes

Gait speed
Timed up and go test
30 second chair-stand test


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group: 12 weeks low load strength training program of the quadriceps femoris

Interventions/Control_2

Control group: Non-intervention

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) People aged 65 years and over
2) People who are able to ambulate independently

Key exclusion criteria

1) People who had physical dysfunctions that may influence outcome measures, such as neurological impairment and musculoskeletal impairment
2) Have severe dementia

Target sample size

26


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 Kojiro Araki

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

Homepage URL


Email

araki.koujirou.77s@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

None

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

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

2015 Year 04 Month 06 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

No longer recruiting

Date of protocol fixation

2015 Year 04 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2016 Year 03 Month 01 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2015 Year 04 Month 06 Day

Last modified on

2016 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019779


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name