UMIN-ICDS Clinical Trial

Public title

Changes in Voice Health, Mental Well-Being, and Social Connections Among Participants in a Healthy Voice Training Program Incorporating Sports Cheering

Acronym

VTSC Study

Scientific Title

Changes in Voice-Related Quality of Life and Psychosocial Outcomes Associated with Participation in a Healthy Voice Training Program Incorporating Sports Cheering

Scientific Title:Acronym

VTSC Study

Region

Japan

Condition

Voice-related quality of life and psychosocial well-being

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to examine changes in voice-related quality of life and psychological well-being associated with participation in a healthy voice training program incorporating sports cheering. Questionnaire surveys will be conducted at three time points: before the program, immediately after the sports cheering event, and approximately one month after the event. Changes in Voice-Related Quality of Life (V-RQOL) and psychological well-being (WHO-5), including their maintenance at follow-up, will be examined. Changes in psychosocial outcomes, including team identification, interest in sports cheering and spectating, social networks, social participation, and frequency of outings, will also be explored.

Basic objectives2

Others

Basic objectives -Others

Exploration of longitudinal changes in voice-related quality of life and psychosocial well-being associated with participation in a health promotion program

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Change in the Voice-Related Quality of Life (V-RQOL) score from baseline (before the program) to immediately after the sports cheering event

Key secondary outcomes

1. Change in the WHO-5 Well-Being Index score from baseline to immediately after the sports cheering event.
2. Changes in V-RQOL and WHO-5 scores across three time points: baseline, immediately after the sports cheering event, and approximately one month after the event.
3. Changes in team identification as assessed by the Sport Team Identification Scale (STIS).
4. Changes in social networks as assessed by the six-item Lubben Social Network Scale (LSNS-6).
5. Changes in interest in sports cheering and spectating, and intentions for future participation.
6. Changes in social participation, frequency of outings, and self-rated health.
These outcomes will be assessed using responses collected at the applicable measurement time points: baseline, immediately after the sports cheering event, and approximately one month after the event.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Individuals participating in the Healthy Voice Training and Sports Cheering Program at one of the four designated venues.
2. Individuals aged 18 years or older at the start of the program.
3. Individuals who understand the study information and voluntarily provide electronic informed consent to participate in the study.

Key exclusion criteria

1. Individuals who are unable to understand the study information or questionnaires in Japanese and respond independently.
2. Individuals for whom the principal investigator or other study investigators determine that the study procedures cannot be conducted safely or appropriately.
3. Individuals who are unable to complete the web-based questionnaires.

Target sample size

200

Name of lead principal investigator

1st name	SATO
Middle name
Last name	Kenichiro

Organization

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Division name

Research Team for Social Participation and Healthy Aging

Zip code

173-0004

Address

8F Itabashi Center Building 3-9-7 Itabashi, Itabashi-ku, Tokyo 173-0004, JAPAN

TEL

03-6905-6781

Email

sato_ken@tmig.or.jp

Name of contact person

1st name	SATO
Middle name
Last name	Kenichiro

Organization

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Division name

Research Team for Social Participation and Healthy Aging

Zip code

173-0004

Address

8F Itabashi Center Building 3-9-7 Itabashi, Itabashi-ku, Tokyo 173-0004, JAPAN

TEL

03-6905-6781

Homepage URL

Email

sato_ken@tmig.or.jp

Institute

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Institute

Department

Personal name

Organization

Japan Koemigaki Association

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Metropolitan Institute for Geriatrics and Gerontology Institutional Review Board

Address

35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan

Tel

03-3964-3241

Email

naomi_hasegawa@tmghig.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都健康長寿医療センター研究所（東京都）

Date of disclosure of the study information

2026

Year

11

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

11

Month

09

Day

Date of IRB

2026

Year

11

Month

09

Day

Anticipated trial start date

2026

Year

11

Month

09

Day

Last follow-up date

2027

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a prospective, single-cohort longitudinal observational study examining changes in voice-related quality of life and psychosocial outcomes associated with participation in a healthy voice training program incorporating sports cheering.

Participants will be recruited from an existing community-based program conducted in four areas of Osaka and Nara Prefectures, Japan. Eligible participants are adults aged 18 years or older who voluntarily provide informed consent. The target sample size is up to 200 participants. Participants will be recruited through convenience sampling, without random selection or researcher-controlled allocation.

Web-based questionnaire surveys will be conducted at three time points: before the program, immediately after the sports cheering event, and approximately one month after the event. The principal outcomes are voice-related quality of life (V-RQOL) and psychological well-being (WHO-5). Changes from baseline to immediately after the event and subsequent trajectories will be examined. Additional exploratory outcomes include team identification, intentions to attend or participate in sports cheering, social networks (LSNS-6), social participation, and frequency of outings.

The researchers will not determine the program content, number of sessions, or allocation of participants. No control group will be established. Depending on the venue, participants will attend one or two training sessions. The findings will be interpreted as changes associated with program participation rather than evidence of causal effects.

Registered date

2026

Year

11

Month

09

Day

Last modified on

2026

Year

11

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072748