UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036890
Receipt number R000042040
Scientific Title Impact of exercise induced muscle damage on the balance and postural control in the older adults
Date of disclosure of the study information 2019/05/30
Last modified on 2019/05/30 03:23:35

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Basic information

Public title

Impact of exercise induced muscle damage on the balance and postural control in the older adults

Acronym

Exercise induced muscle damage and balance and postural control

Scientific Title

Impact of exercise induced muscle damage on the balance and postural control in the older adults

Scientific Title:Acronym

Exercise induced muscle damage and balance and postural control

Region

Asia(except Japan)


Condition

Condition

Balance and postural control

Classification by specialty

Geriatrics Rehabilitation medicine Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Impact of exercise induced muscle damage on the balance and postural control in the older adults

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

Balance
Postural control
Fear of Falling
Perceived Muscle Soreness
Muscle Strength
Joint Position Sense

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

contradictory

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



Eligibility

Age-lower limit

60 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

A score more than 26 on the mini-mental state examination; Mild to moderate intensity physical activities (walking, jogging, or endurance activities) for equal and more than 12 months prior to recruitment.

Key exclusion criteria

Reported a history of lower extremity injury; ferrous metal implants; Musculoskeletal disorders;psychiatric, neurological, and/or inflammatory diseases.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Aynollah
Middle name
Last name Naderi

Organization

Shahrood University of Technology, Semnan, Iran

Division name

Physical Education and Sport Sciences

Zip code

35437634634

Address

Shahrood, Semnan, Iran

TEL

+989177217462

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

School of Sport Sciences

Zip code

35437634634

Address

Shahrood, Semnan, Iran

TEL

+899177217462

Homepage URL


Email

ay.naderi@shahroodut.ac.ir


Sponsor or person

Institute

Shahrood University of Technology, Semnan, Iran

Institute

Department

Personal name



Funding Source

Organization

Shahrood University of Technology, Semnan, Iran

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shahrood University of Technology

Address

Semnan, Iran

Tel

+989177217462

Email

ay.naderi@shahroodut.ac.ir


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 05 Month 30 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

Enrolling by invitation

Date of protocol fixation

2019 Year 05 Month 04 Day

Date of IRB

2019 Year 03 Month 02 Day

Anticipated trial start date

2019 Year 06 Month 10 Day

Last follow-up date

2019 Year 08 Month 14 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 05 Month 30 Day

Last modified on

2019 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name