UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of low-intensity resistance training combined neuromuscular electrical stimulation on autonomic activity: a randomized controlled trial
Title of the study (Brief title)	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	Toshiki Kutsuna
Organization	Tokyo University of Technology
Division name	Department of Physical Therapy, School of Health Sciences
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	Toshiki Kutsuna
Organization	Tokyo University of Technology
Division name	Department of Physical Therapy, School of Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000035855