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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031403
Receipt No. R000035855
Scientific Title Effects of low-intensity resistance training combined neuromuscular electrical stimulation on autonomic activity: a randomized controlled trial
Date of disclosure of the study information 2018/02/21
Last modified on 2019/02/05

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Basic information
Public title Effects of low-intensity resistance training combined neuromuscular electrical stimulation on autonomic activity: a randomized controlled trial
Acronym Effects of low-intensity resistance training combined neuromuscular electrical stimulation on autonomic activity
Scientific Title Effects of low-intensity resistance training combined neuromuscular electrical stimulation on autonomic activity: a randomized controlled trial
Scientific Title:Acronym Effects of low-intensity resistance training combined neuromuscular electrical stimulation on autonomic activity
Region
Japan

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

Objectives
Narrative objectives1 This study aims to investigate the effects of low-intensity resistance training combined neuromuscular electrical stimulation on autonomic activity in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sympathetic activity, parasympathetic activity
Key secondary outcomes Isometric strength of knee extensors, muscle contractile property measurements, thigh circumference, quadriceps muscle thickness, lower-limb muscle mass

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Subjects perform the low-intensity resistance training combined neuromuscular electrical stimulation. The intervention focuses on isometric knee extension exercises, and its intensity is set at 40% of maximum voluntary contraction. The resistance training is performed three times per week during 6 weeks.
Interventions/Control_2 Subjects perform the low-intensity resistance training without neuromuscular electrical stimulation. The intervention focuses on isometric knee extension exercises, and its intensity is set at 40% of maximum voluntary contraction. The resistance training is performed three times per week during 6 weeks.
Interventions/Control_3 Subjects perform the high-intensity resistance training without neuromuscular electrical stimulation. The intervention focuses on isometric knee extension exercises, and its intensity is set at 80% of maximum voluntary contraction. The resistance training is performed three times per week during 6 weeks.
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

Not applicable
Gender Male
Key inclusion criteria Healthy adults
Key exclusion criteria Subjects who have contraindications for neuromuscular electrical stimulation, or engage in regular exercise
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiki Kutsuna
Organization Tokyo University of Technology
Division name Department of Physical Therapy, School of Health Sciences
Zip code
Address 5-23-22, Nishikamata, Ota-ku, Tokyo 144-8535, JAPAN
TEL 0364242205
Email t.kutsuna.1981@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Kutsuna
Organization Tokyo University of Technology
Division name Department of Physical Therapy, School of Health Sciences
Zip code
Address 5-23-22, Nishikamata, Ota-ku, Tokyo 144-8535, JAPAN
TEL 0364242205
Homepage URL
Email t.kutsuna.1981@gmail.com

Sponsor
Institute Tokyo University of Technology
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 東京工科大学

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 21 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 Completed
Date of protocol fixation
2018 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 12 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
2018 Year 02 Month 21 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035855

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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