UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035420
Receipt number R000040354
Scientific Title Effects of different recovery strategies following an exercise-induced muscle damage on balance, walking, and fear of falling in the older adults
Date of disclosure of the study information 2019/01/17
Last modified on 2019/01/17 16:33:40

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Basic information

Public title

Effects of different recovery strategies following an exercise-induced muscle damage on balance, walking, and fear of falling in the older adults

Acronym

different recovery strategies and balance, walking, and fear of falling in the older adults

Scientific Title

Effects of different recovery strategies following an exercise-induced muscle damage on balance, walking, and fear of falling in the older adults

Scientific Title:Acronym

different recovery strategies and balance, walking, and fear of falling in the older adults

Region

Asia(except Japan)


Condition

Condition

exercise-induced muscle damage

Classification by specialty

Geriatrics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to investigate effects of different recovery strategies following an exercise-induced muscle damage on balance, walking, and fear of falling in the older adults

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Balance

Key secondary outcomes

Walking
Fear of falling
Postural control


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation


Institution consideration


Blocking

YES

Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Active recovery

Interventions/Control_2

Massage

Interventions/Control_3

Immersion in cold water

Interventions/Control_4

Passive recovery

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

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

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Aynollah Naderi

Organization

Shahrood University of Technology

Division name

Department of Health and Corrective Exercise, School of Sport Sciences

Zip code


Address

Shahrood, Semnan, Iran

TEL

+989177217462

Email

ay.naderi@shahroodut.ac.ir


Public contact

Name of contact person

1st name
Middle name
Last name Aynollah Naderi

Organization

Shahrood University of Technology

Division name

Department of Health and Corrective Exercise, School of Sport Sciences

Zip code


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

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2019 Year 01 Month 14 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 30 Day

Last follow-up date


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 01 Day

Last modified on

2019 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040354


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name