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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029614
Receipt No. R000033829
Scientific Title Effectiveness of the short term Nordic Hamstring exercises on knee flexor muscle strength and fascicle length of biceps femoris long head in healthy male individuals
Date of disclosure of the study information 2017/10/23
Last modified on 2017/10/18

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Basic information
Public title Effectiveness of the short term Nordic Hamstring exercises on knee flexor muscle strength and fascicle length of biceps femoris long head in healthy male individuals
Acronym Effectiveness of the short term Nordic Hamstring exercises in healthy male individuals
Scientific Title Effectiveness of the short term Nordic Hamstring exercises on knee flexor muscle strength and fascicle length of biceps femoris long head in healthy male individuals
Scientific Title:Acronym Effectiveness of the short term Nordic Hamstring exercises in healthy male individuals
Region
Japan

Condition
Condition Healthy
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effectiveness of the short term Nordic Hamstring exercise on knee flexor strength and fascicle length of biceps femoris long head
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcomes
-Knee flexor muscle strength
-Fascicle length of biceps femoris long head

Evaluation time
-Initial assessment; prior to the exercise
-After 1 week of the exercises
-At the end of the exercise period (3 weeks)
-After the additional 1 month de-training period
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Apply 3 weeks Nordic Hamstring exercises on twice a week
Exercise dozen is progressed as below
Week 1; 6 repetitions, 2 sets
Week 2; 6 repetitions, 3 sets
Week 3; 8 repetitions, 4 sets
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
20 years-old <=
Age-upper limit
35 years-old >=
Gender Male
Key inclusion criteria Healthy male individuals with no pain and injury
Key exclusion criteria -Participants who had soft tissue and orthopedic injuries to the trunk, hip and lower limbs in the past 12 months
-Participants who have a history of hamstring strain, anterior cruciate ligament or other traumatic knee injury
-Participants who have a experience in eccentric training
-Participants who have a systemic disease such as rheumatoid arthritis and thyroid disease
-Participants who are deemed difficult to continue a physical exercise
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yudai Sasaki
Organization Akita City Hospital
Division name Department of Rehabilitation
Zip code
Address 4-30, Kawamoto Matsuokamachi, Akita-shi, Akita, 010-0933, Japan
TEL 018-823-4171
Email yudaisasaki0@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yudai Sasaki
Organization Akita City Hospital
Division name Department of Rehabilitation
Zip code
Address 4-30, Kawamoto Matsuokamachi, Akita-shi, Akita, 010-0933, Japan
TEL 018-823-4171
Homepage URL
Email yudaisasaki0@gmail.com

Sponsor
Institute Akita City Hospital
Institute
Department

Funding Source
Organization None
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 市立秋田総合病院(秋田県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 23 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 27 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
2017 Year 10 Month 18 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033829

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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