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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082156
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Western Michigan University
Information provided by (Responsible Party):
Omron Healthcare Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Muscle Fatigue Device: electrical stimulation Device: Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Active Comparator: Active TENS Device: electrical stimulation
electrical stimulation

Sham Comparator: Sham TENS Device: Sham
no stimulation




Primary Outcome Measures :
  1. VAS(Visual Analog Scale score) for soreness or pain [ Time Frame: 2weeks ]
    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.

  2. FI (Fatugue Index) [ Time Frame: 2weeks ]
    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 :
  1. sleep quality measurement [ Time Frame: 2weeks ]
    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.

  2. POMS (Profile of Mood States) [ Time Frame: 2weeks ]
    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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082156


Contacts
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Contact: Daryl Lawson, DSc 336-278-6352 daryl.lawson@wmich.edu

Locations
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Japan
Omron healthcare Co.,Ltd. Recruiting
Muko, Japan
Contact: Shozo Takamatsu    +81-75-925-2043    shozo.takamatsu@omron.com   
Contact: Keisuke Yamada    +81-75-925-2043    K.Yamada@omron.com   
Sponsors and Collaborators
Omron Healthcare Co., Ltd.
Western Michigan University
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Responsible Party: Omron Healthcare Co., Ltd.
ClinicalTrials.gov Identifier: NCT04082156    
Other Study ID Numbers: HI794-0014
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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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
Keywords provided by Omron Healthcare Co., Ltd.:
TENS, DOMS, soreness, fatigue
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms