UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037341
Receipt number R000042566
Scientific Title Influence of the senior stretch leader training course on the physical and psychological functions of the trainesse
Date of disclosure of the study information 2019/07/12
Last modified on 2019/07/11 21:18:11

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Basic information

Public title

Influence of the senior stretch leader training course on the physical and psychological functions of the trainesse

Acronym

Influence of the senior stretch leader training course on the physical and psychological functions of the trainesse

Scientific Title

Influence of the senior stretch leader training course on the physical and psychological functions of the trainesse

Scientific Title:Acronym

Influence of the senior stretch leader training course on the physical and psychological functions of the trainesse

Region

Japan


Condition

Condition

Elderly people

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine about an effective that Senior Stretch Leader Training Course gives to physical and psychological function of elderly people

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Physical function (walking ability, muscle strength, flexibility), before and after 8 weeks intervention study

Key secondary outcomes

Stretching practice frequency
Sense of coherence
Geriatric Depression Scale-15
Frail criteria
Pittsburgh sleep quality index
Physical fitness related self-efficacy
Physical activity scale for the elderly
Apathy Evaluation Scale
Lubben Social Network Scale
Purpose of participation



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Attending a senior stretch leader training course (theory and practice) for 8 weeks (total 8 times) and stretching practice at home

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

(1)Participants is fully informed about the study and has signed the information consent form
(2)Participant who are not prohibited from exercising by a doctor
(3)Age of 65 years of older

Key exclusion criteria

Not applicable

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tomohiro
Middle name
Last name Okura

Organization

University of Tsukuba

Division name

Faculty of Health and Sport-Sciences

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki , JAPAN

TEL

029-853-2660

Email

okura.tomohiro.gp@u.taiiku.tsukuba.ac.jp


Public contact

Name of contact person

1st name Kaya
Middle name
Last name Joho

Organization

University of Tsukuba

Division name

Graduate School of Comprehensive Human Sciences in Human Care Sciences

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki , JAPAN

TEL

029-853-2660

Homepage URL


Email

s1830333@s.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Sasakawa Sports Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba, Ibaraki , JAPAN

Tel

029-853-2571

Email

hitorinri@un.tsukuba.ac.jp


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

2019 Year 07 Month 12 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

2019 Year 05 Month 07 Day

Date of IRB

2019 Year 05 Month 07 Day

Anticipated trial start date

2019 Year 07 Month 16 Day

Last follow-up date

2019 Year 09 Month 25 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 07 Month 11 Day

Last modified on

2019 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name