UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000063557
Receipt number R000072733
Scientific Title Effects of a bone-strengthening program on posture and gait indices in healthy older women: a cluster randomized controlled trial
Date of disclosure of the study information 2026/11/07
Last modified on 2026/11/07 18:39:46

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Basic information

Public title

Effects of a bone-strengthening program on posture and gait indices in older adults

Acronym

Effects of a bone-strengthening program on posture and gait indices in older adults

Scientific Title

Effects of a bone-strengthening program on posture and gait indices in healthy older women: a cluster randomized controlled trial

Scientific Title:Acronym

Effects of a bone-strengthening program on posture and gait indices in healthy older women: a cluster randomized controlled trial

Region

Japan


Condition

Condition

Healthy older women

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of a 2-month bone-strengthening program (exercise to strengthen bones, increase joint range of motion, and align the skeleton) on posture and gait indices in healthy older women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Posture assessed with the posture-analysis app 'Shisei Karte', at baseline and after 2 months.

Key secondary outcomes

6-m walking speed and Two-Step test (stride evaluation), at baseline and after 2 months.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Bone-strengthening program (exercise to strengthen bones, increase joint range of motion and align the skeleton), 60 minutes once a week for 2 months.

Interventions/Control_2

No intervention; participants continue their usual daily life.

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

80 years-old >=

Gender

Female

Key inclusion criteria

Healthy women aged 65 to 80 years.

Key exclusion criteria

Individuals with diseases that impair walking.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Shiho
Middle name
Last name Kurosaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8524

Address

1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan

TEL

082-424-6844

Email

shihok@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Shiho
Middle name
Last name Kurosaka

Organization

Hiroshima University

Division name

Graduate School of Humanities and Social Sciences

Zip code

739-8524

Address

1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan

TEL

082-424-6844

Homepage URL


Email

shihok@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Co-op Hiroshima (Hiroshima Consumers' Co-operative)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, Graduate School of Humanities and Social Sciences, Hiroshima University

Address

1-1-1 Kagamiyama, Higashi-Hiroshima, Hiroshima 739-8524, Japan

Tel

082-424-6844

Email

shihok@hiroshima-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

HR-ES-004524

Org. issuing International ID_1

Ethics Committee, Graduate School of Humanities and Social Sciences, Hiroshima University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

広島県内の公民館(広島県)


Other administrative information

Date of disclosure of the study information

2026 Year 11 Month 07 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

2026 Year 08 Month 10 Day

Date of IRB

2026 Year 08 Month 28 Day

Anticipated trial start date

2026 Year 11 Month 09 Day

Last follow-up date

2027 Year 01 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2026 Year 11 Month 07 Day

Last modified on

2026 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072733