UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035524
Receipt number R000040473
Scientific Title Influence of wearing shoe type on the consequences of a fall prevention exercise program in the older adults
Date of disclosure of the study information 2019/01/17
Last modified on 2020/10/30 21:06:02

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Basic information

Public title

Added value of accounting for wearing unstable shoes during an agility-based circuit training among older adults

Acronym

value of wearing unstable shoes among older adults

Scientific Title

Influence of wearing shoe type on the consequences of a fall prevention exercise program in the older adults

Scientific Title:Acronym

value of wearing unstable shoes among older adults

Region

Asia(except Japan)


Condition

Condition

older adult

Classification by specialty

Geriatrics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate effects of wearing unstable shoes during an agility-based circuit training among older adults

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Balance

Key secondary outcomes

Ankle plantar flexor muscle strength
Mobility
Postural stability
Fear of falling


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Wearing unstable shoes and agility-based circuit training

Interventions/Control_2

Wearing usual shoes and agility-based circuit training

Interventions/Control_3

Control

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Inclusion criteria: Age over 65 years; Independent living in the community.

Key exclusion criteria

Exclusion criteria: History of bone metabolic disease and corticosteroids consumption; history of severe musculoskeletal disorders (such as lower back , knee or hip joint arthritis) and / or arthroscopy and artificial implants; history of neurological complications/problems (such as Parkinson's disease, stroke, spinal cord injury and cerebral palsy).

Target sample size

57


Research contact person

Name of lead principal investigator

1st name Aynollah
Middle name
Last name Naderi

Organization

Shahrood University of Technology

Division name

Department of Health and Corrective Exercise, School of Sport Sciences

Zip code

3619995161

Address

Shahrood, Semnan, Iran

TEL

+899177217462

Email

ay.naderi@shahroodut.ac.ir


Public contact

Name of contact person

1st name Aynollah
Middle name
Last name Naderi

Organization

Shahrood University of Technology

Division name

Department of Health and Corrective Exercise, School of Sport Sciences

Zip code

3619995161

Address

Shahrood, Semnan, Iran

TEL

+899177217462

Homepage URL


Email

ay.naderi@shahroodut.ac.ir


Sponsor or person

Institute

Shahrood University of Technology

Institute

Department

Personal name



Funding Source

Organization

Shahrood University of Technology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institute of higher education in civil and development

Address

Hamedan, Iran

Tel

+9186726462

Email

bagherishahab@yahoo.com


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 01 Month 17 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

75

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

No longer recruiting

Date of protocol fixation

2019 Year 02 Month 05 Day

Date of IRB

2019 Year 02 Month 01 Day

Anticipated trial start date

2019 Year 03 Month 05 Day

Last follow-up date

2019 Year 09 Month 05 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 01 Month 11 Day

Last modified on

2020 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040473


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name