UMIN-ICDS Clinical Trial

Public title

A study of whether older adults can continue a home voice practice program and how their breathing muscle strength changes

Acronym

Home Voice Practice Study

Scientific Title

Feasibility of a Home-Based Phonation Task Program and Changes in Respiratory Muscle Strength in Community-Dwelling Older Adults: A Single-Arm Intervention Study

Scientific Title:Acronym

Home Phonation Program Feasibility Study

Region

Japan

Condition

Community-dwelling older adults

Classification by specialty

Geriatrics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the feasibility of a gamified home-based phonation task program (MeVox), in which participants control an on-screen character by voice intensity, and to describe changes in respiratory muscle strength in community-dwelling older adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Percent-predicted maximal expiratory pressure (MEP%) and maximal inspiratory pressure (MIP%), assessed twice at baseline (T1 and T2, 2 weeks apart), every 2 weeks during the 6-week intervention (T3-T5), and at follow-up (T6).

Key secondary outcomes

Feasibility (program completion rate, dropouts, adverse events), practice frequency (trials/week), in-app tracking score (0-100), self-efficacy (0-10 scale), daily step count, percent-predicted vital capacity (VC%), forced expiratory volume in 1 second ratio (FEV1.0%), skeletal muscle mass index (SMI), and handgrip strength.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

After a 2-week baseline period, participants perform a 6-week home-based phonation task program using a loaned Chromebook running a voice game application (MeVox). In each 20-s trial, participants control an on-screen character by voice intensity (louder to move up, softer to move down) to track a guide trajectory, and a tracking score (0-100) is displayed after each trial. The prescribed dose is at least 3 trials per day on at least 3 days per week. Physical therapists visit participants every 2 weeks at home or at a day-service facility to review performance, address barriers, and adjust task difficulty (hybrid model).

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

65

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Community-dwelling adults aged 65 years or older; (2) able to perform phonation practice at home using a Chromebook; (3) provided written informed consent.

Key exclusion criteria

(1) Diagnosis of dementia; (2) presence of respiratory disease.

Target sample size

6

Name of lead principal investigator

1st name	Yuji
Middle name
Last name	Morio

Organization

Shonan University of Medical Sciences

Division name

Department of Rehabilitation, Faculty of Medical Sciences

Zip code

244-0806

Address

16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN

TEL

+81-45-821-0111

Email

yuji.morio@sums.ac.jp

Name of contact person

1st name	Yuji
Middle name
Last name	Morio

Organization

Shonan University of Medical Sciences

Division name

Department of Rehabilitation, Faculty of Medical Sciences

Zip code

244-0806

Address

16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN

TEL

+81-45-821-0111

Homepage URL

Email

yuji.morio@sums.ac.jp

Institute

Shonan University of Medical Sciences

Institute

Department

Personal name

Yuji Morio

Organization

Sasakawa Health Foundation SHF

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shonan University of Medical Sciences

Address

16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN

Tel

+81-45-821-0111

Email

y_morio@icloud.com

Secondary IDs

YES

Study ID_1

24-029

Org. issuing International ID_1

Research Ethics Committee, Shonan University of Medical Sciences

Study ID_2

26-037

Org. issuing International ID_2

Research Ethics Committee, Shonan University of Medical Sciences

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

28

Day

URL releasing protocol

Not applicable

Publication of results

Unpublished

URL related to results and publications

Not applicable

Number of participants that the trial has enrolled

6

Results

Compared with baseline, median changes during the intervention were +12.3 percentage points in MEP% (increase in 5 of 6 participants), +4.4 points in MIP% (4 of 6), +3.2 points in VC%, and -1.7 points in FEV1.0%. All participants, including those with limited technology experience, completed the program, and practice frequency, in-app scores, and self-efficacy increased during the intervention.

Results date posted

2026

Year

09

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Six community-dwelling women aged 77-83 years.

Participant flow

Six participants were enrolled, and all six completed the 6-week intervention.

Adverse events

No intervention-related adverse events were observed.

Outcome measures

Compared with baseline, median changes during the intervention were +12.3 percentage points in MEP% (increase in 5 of 6 participants), +4.4 points in MIP% (4 of 6), +3.2 points in VC%, and -1.7 points in FEV1.0%. All participants, including those with limited technology experience, completed the program, and practice frequency, in-app scores, and self-efficacy increased during the intervention.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2024

Year

11

Month

12

Day

Date of IRB

2024

Year

11

Month

12

Day

Anticipated trial start date

2024

Year

12

Month

02

Day

Last follow-up date

2025

Year

09

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This trial was conducted as part of the research project "Development of respiratory function-based assessment and training to promote telemedicine," approved by the Research Ethics Committee of Shonan University of Medical Sciences (approval No. 24-029). After that project ended, data analysis and publication continued under the successor project that encompasses it, "Exploration of physical and respiratory function using sensor fusion to quantify the risk of health loss and to inform preventive interventions in older adults" (approval No. 26-037). Because the trial was planned and conducted as a small-scale feasibility study, it was not registered before participant enrollment.

Registered date

2026

Year

09

Month

28

Day

Last modified on

2026

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072202