UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031403 |
|---|---|
| Receipt number | 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 18:27:51 |
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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
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
t.kutsuna.1981@gmail.com
Sponsor or person
Institute
Tokyo University of Technology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035855
