Muscle FatigueNCT04082156
The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
A study testing electrical stimulation in people with Muscle Fatigue, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
Trial summary
The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 15 Jul 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- English speaking
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Omron healthcare Co.,Ltd.
Mukō
Shozo Takamatsu, +81-75-925-2043, shozo.takamatsu@omron.com
Keisuke Yamada, +81-75-925-2043, K.Yamada@omron.com
About this study
The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.
- Conditions
- Muscle Fatigue
- Being tested
- electrical stimulation, Sham
- Keywords
- TENS, DOMS, soreness, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulationDevice
electrical stimulation
ShamDevice
no stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | Not described Receives: Device: electrical stimulation |
| Sham TENS | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2weeks
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.
Measured: 2weeks
Secondary outcomes (2)
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.
Measured: 2weeks
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".
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start15 Jul 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omron Healthcare Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Western Michigan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082156
- Sponsor's protocol ID
- HI794-0014
- Status last verified
- Mar 2020
- First submitted
- 28 Aug 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports
- ClinicalTrials.gov ID
- NCT04082156
- Acronym / sponsor ID
- HI794-0014
- Conditions
- Muscle Fatigue
- Keywords
- TENS, DOMS, soreness, fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Omron Healthcare Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Western Michigan University
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to assess if TENS will improve the muscle recovery rate from post-exercise fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: electrical stimulation |
| Sham TENS | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- English speaking
Key exclusion criteria (13 listed)
- Pregnancy
- Diabetes Mellitus
- Neuropathy
- Smoker
- Uncontrolled Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical stimulationelectrical stimulation | Device | Active TENS |
| Shamno stimulation | Device | Sham TENS |
Primary outcome
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.
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.
2 secondary outcomes
sleep quality measurement
Time frame: 2weeks
POMS (Profile of Mood States)
Time frame: 2weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation in people with Muscle Fatigue, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daryl Lawson, DSc (336-278-6352, daryl.lawson@wmich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS(Visual Analog Scale score) for soreness or pain (time frame: 2weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.