UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Different Recovery Techniques on Balance and Fear of Falling following Exercise-Induced Muscle Damage in Older Adults
Acronym	Effects of Different Recovery Techniques on Older Adults
Scientific Title	Effects of Different Recovery Techniques on Balance and Fear of Falling following Exercise-Induced Muscle Damage in Older Adults
Scientific Title:Acronym	Different Recovery Techniques and Balance and Fear of Falling
Region	Asia(except Japan)

Condition
Condition	Exercise-Induced Muscle Damage
Classification by specialty	Medicine in general Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of Different Recovery Techniques on Balance and Fear of Falling following Exercise-Induced Muscle Damage in Older Adults
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fear of Falling Balance
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Massage
Interventions/Control_2	Ice
Interventions/Control_3	active
Interventions/Control_4	control
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; able to perform physical activity safely as assessed by the Physical-Activity Readiness Questionnaire (PAR-Q); and Physician approval prior to Exclusion criteria were: reported a history of lower extremity injury; ferrous metal implants; musculoskeletal disorders; psychiatric, neurological, and/or inflammatory diseases.
Key exclusion criteria	Exclusion criteria were: reported a history of lower extremity injury; ferrous metal implants; musculoskeletal disorders; psychiatric, neurological, and/or inflammatory diseases. In addition, for 72 h prior to the baseline testing day and for the duration of the study participants were request to refrain from any additional exercise, and abstain from therapeutic treatments including massage as well as use of supplements, any medications, caffeine, nicotine or alcohol.
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
Division name	Physical Education and Sport Sciences
Zip code	35437634634
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	School of Sport Sciences
Zip code	35437634634
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)

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 06 Month 04 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 04 Month 03 Day
Date of IRB	2019 Year 02 Month 07 Day
Anticipated trial start date	2019 Year 06 Month 20 Day
Last follow-up date	2019 Year 11 Month 01 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 06 Month 04 Day
Last modified on	2019 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042041