UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035542
Receipt number R000040499
Scientific Title Does stronger lower limbs muscle stimulate physical activity in the snowy season?
Date of disclosure of the study information 2019/01/16
Last modified on 2019/01/15 10:59:48

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Basic information

Public title

Does stronger lower limbs muscle stimulate physical activity in the snowy season?

Acronym

Does stronger lower limbs muscle stimulate physical activity in the snowy season?

Scientific Title

Does stronger lower limbs muscle stimulate physical activity in the snowy season?

Scientific Title:Acronym

Does stronger lower limbs muscle stimulate physical activity in the snowy season?

Region

Japan


Condition

Condition

Healthy community dwelling elderly

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1


Examine the influence of lower limb muscle strengthening on the physical activity in the snowy season

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Daily step count in the snowy season

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

one-hour exercise, twice a week for 12 weeks

Interventions/Control_2


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

Independently living in a community

Key exclusion criteria

Needs care for daily activity

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junko Hasegawa

Organization

Health Sciences University of Hokkaido

Division name

School of Rehabilitation Sciences

Zip code


Address

1757, Kanazawa, Ishikari-tobetsu, Hokkaido, Japan

TEL

0133231211

Email

j-hasegawa@hoku-iryo-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Hasegawa

Organization

Health Sciences University of Hokkaido

Division name

School of Rehabilitation Sciences

Zip code


Address

1757, Kanazawa, Ishikari-tobetsu, Hokkaido, Japan

TEL

0133231211

Homepage URL


Email

j-hasegawa@hoku-iryo-u.ac.jp


Sponsor or person

Institute

Health Sciences University of Hokkaido

Institute

Department

Personal name



Funding Source

Organization

Health Sciences University of Hokkaido

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

北海道医療大学


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 16 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

2018 Year 01 Month 20 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2019 Year 01 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 15 Day

Last modified on

2019 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name