UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of different recovery strategies following an exercise-induced muscle damage on balance, walking, and fear of falling in the older adults
Title of the study (Brief title)	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	Aynollah Naderi
Organization	Shahrood University of Technology
Division name	Department of Health and Corrective Exercise, School of Sport Sciences
Address	Shahrood, Semnan, Iran
TEL	+989177217462
Email	ay.naderi@shahroodut.ac.ir

Public contact
Name of contact person	Aynollah Naderi
Organization	Shahrood University of Technology
Division name	Department of Health and Corrective Exercise, School of Sport Sciences
Address	Shahrood, Semnan, Iran
TEL	+899177217462
Homepage URL
Email	ay.naderi@shahroodut.ac.ir

Sponsor
Institute	Shahrood University of Technology
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040354