UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021035
Receipt number R000024276
Scientific Title Effects of spectating professional baseball at the stadium on health-related outcomes in middle-aged and older adults
Date of disclosure of the study information 2016/02/15
Last modified on 2019/08/18 16:53:37

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Basic information

Public title

Effects of spectating professional baseball at the stadium on health-related outcomes in middle-aged and older adults

Acronym

Spectating professional baseball and health-related outcomes

Scientific Title

Effects of spectating professional baseball at the stadium on health-related outcomes in middle-aged and older adults

Scientific Title:Acronym

Spectating professional baseball and health-related outcomes

Region

Japan


Condition

Condition

Depression
Dementia

Classification by specialty

Geriatrics Psychiatry Neurosurgery
Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of spectating professional baseball at the stadium on health-related outcomes, such as mental health, cognitive function, and quality of life.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

- Depressive symptoms
- Cognitive function

Key secondary outcomes

- Quality of life
- Subjective well-being
- Physical activity
- Blood pressure


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are 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

1. Intervention period (voluntarily spectating professional baseball for 2 months)
2. Control period (ordinary life for 2 months)

Interventions/Control_2

1. Control period (ordinary life for 2 months)
2. Intervention period (voluntarily spectating professional baseball for 2 months)

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

1. Aged >= 60 years-old
2. Non-club member of a professional baseball team (Saitama Seibu Lions)

Key exclusion criteria

1. Insured person requiring long-term care
2. Person who requires assistance during spectating
3. Patients with dementia or depression
4. Person who regularly spectate sports at a stadium
5. Person who is employed and/or works as a volunteer

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuru Higuchi

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15 Mikajima, Tokorozawa, Saitama

TEL

04-2947-6745

Email

mhiguchi@waseda.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryoko Kawakami

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15 Mikajima, Tokorozawa, Saitama

TEL

04-2947-6833

Homepage URL


Email

r.kawakami@aoni.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Seibu Lions Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

National Institutes of Biomedical Innovation,
Health and Nutrition

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 15 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

Main results already published

Date of protocol fixation

2015 Year 12 Month 16 Day

Date of IRB

2015 Year 10 Month 09 Day

Anticipated trial start date

2016 Year 02 Month 16 Day

Last follow-up date

2016 Year 09 Month 09 Day

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 15 Day

Last modified on

2019 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024276


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name