search
Back to results

The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports

Primary Purpose

Muscle Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
electrical stimulation
Sham
Sponsored by
Omron Healthcare Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Fatigue focused on measuring TENS, DOMS, soreness, fatigue

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • No phobia of electrical stimulation
  • No pain or anti-inflammatory medication will be taken during study
  • English speaking

Exclusion Criteria:

  • Pregnancy
  • Diabetes Mellitus
  • Neuropathy
  • Smoker
  • Uncontrolled Hypertension
  • Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
  • Rhumatoid Arthritis (RA) in the area to be treated by TENS
  • Allergic to tape/electrodes
  • Dementia
  • History of knee joint replacement or tibial osteotomy
  • Undergoing physical therapy
  • Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
  • Contraindications to TENS such as having a pacemakers, dermatological conditions, and abnormal sensation of the lower extremity.

Sites / Locations

  • Omron healthcare Co.,Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active TENS

Sham TENS

Arm Description

Outcomes

Primary Outcome Measures

VAS(Visual Analog Scale score) for soreness or pain
Participants will record their level of knee pain by drawing a vertical mark between the ends of a 10-cm horizontal line. The 0-cm end and the 10-cm end represented no pain and the most extreme pain, respectively. The distance from the 0-cm end to the drawn mark was recorded to the first decimal place.
FI (Fatugue Index)
A system called "Just Jump" by Probotics* will be used to induce DOMS. The goal of the jump is to create fatigue of the lower extremities which is a byproduct of decreased power. It will also create exercise induces DOMS. Using this system the next day will test the fatigue and power of the lower extremities to see if it has changed.

Secondary Outcome Measures

sleep quality measurement
Each subject will be provided with Sleep measurment device. The device captures sleep data via a sensor to monitor breathing, body movemement along with ambient light and temperature in the bedroom. The device is composed of six sleep parameters that combine to reflect the overall quality of sleep. It has objective sleep data, SleepScore (Objective Sleep Quality), MindScore (Objective REM Sleep Quality), BodyScore (Objective Deep Sleep Quality), Total Record Time, Time in Bed, Total Sleep Time, REM Sleep Time, Light Sleep Time, Deep Sleep time, Onset Time, WASO, Total Wake Time, Interruptions.
POMS (Profile of Mood States)
It will be used for mental alertness. It is short form containing 24 items and four scales. Used in sports science (along with other areas) to evaluate and access mood after exercise or a sporting event concerned the certain scales containing "vigour" and "fatigue".

Full Information

First Posted
August 28, 2019
Last Updated
March 12, 2020
Sponsor
Omron Healthcare Co., Ltd.
Collaborators
Western Michigan University
search

1. Study Identification

Unique Protocol Identification Number
NCT04082156
Brief Title
The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
Official Title
The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omron Healthcare Co., Ltd.
Collaborators
Western Michigan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Fatigue
Keywords
TENS, DOMS, soreness, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TENS
Arm Type
Active Comparator
Arm Title
Sham TENS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
electrical stimulation
Intervention Description
electrical stimulation
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
no stimulation
Primary Outcome Measure Information:
Title
VAS(Visual Analog Scale score) for soreness or pain
Description
Participants will record their level of knee pain by drawing a vertical mark between the ends of a 10-cm horizontal line. The 0-cm end and the 10-cm end represented no pain and the most extreme pain, respectively. The distance from the 0-cm end to the drawn mark was recorded to the first decimal place.
Time Frame
2weeks
Title
FI (Fatugue Index)
Description
A system called "Just Jump" by Probotics* will be used to induce DOMS. The goal of the jump is to create fatigue of the lower extremities which is a byproduct of decreased power. It will also create exercise induces DOMS. Using this system the next day will test the fatigue and power of the lower extremities to see if it has changed.
Time Frame
2weeks
Secondary Outcome Measure Information:
Title
sleep quality measurement
Description
Each subject will be provided with Sleep measurment device. The device captures sleep data via a sensor to monitor breathing, body movemement along with ambient light and temperature in the bedroom. The device is composed of six sleep parameters that combine to reflect the overall quality of sleep. It has objective sleep data, SleepScore (Objective Sleep Quality), MindScore (Objective REM Sleep Quality), BodyScore (Objective Deep Sleep Quality), Total Record Time, Time in Bed, Total Sleep Time, REM Sleep Time, Light Sleep Time, Deep Sleep time, Onset Time, WASO, Total Wake Time, Interruptions.
Time Frame
2weeks
Title
POMS (Profile of Mood States)
Description
It will be used for mental alertness. It is short form containing 24 items and four scales. Used in sports science (along with other areas) to evaluate and access mood after exercise or a sporting event concerned the certain scales containing "vigour" and "fatigue".
Time Frame
2weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No phobia of electrical stimulation No pain or anti-inflammatory medication will be taken during study English speaking Exclusion Criteria: Pregnancy Diabetes Mellitus Neuropathy Smoker Uncontrolled Hypertension Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment Rhumatoid Arthritis (RA) in the area to be treated by TENS Allergic to tape/electrodes Dementia History of knee joint replacement or tibial osteotomy Undergoing physical therapy Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability Contraindications to TENS such as having a pacemakers, dermatological conditions, and abnormal sensation of the lower extremity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daryl Lawson, DSc
Phone
336-278-6352
Email
daryl.lawson@wmich.edu
Facility Information:
Facility Name
Omron healthcare Co.,Ltd.
City
Muko
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shozo Takamatsu
Phone
+81-75-925-2043
Email
shozo.takamatsu@omron.com
First Name & Middle Initial & Last Name & Degree
Keisuke Yamada
Phone
+81-75-925-2043
Email
K.Yamada@omron.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports

We'll reach out to this number within 24 hrs