Muscle FatigueLEDNCT04367727
Effect of Light Emitting Diode Therapy on Muscle Fatigue
A study testing Light emitting diode in people with Muscle Fatigue, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to determine the optimal time interval between light emitting diode application and exercise to improve fatigue resistance.The results of this study could be useful in planning a rehabilitation program in musculature disorders and also in athletic training. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue
- What is being tested?
- Light emitting diode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to Jan 2021
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non athletics subjects.
- Age ranges from 20-40 years.
- Body mass index is less than 25 kg/m 2
Who cannot join
- Neurological deficit and recent injury to either upper extremity
- non diagnosed pain .
- Contraindications to LED irradiation (such as light hypersensitivity, fluctuating blood pressure, insufficient blood circulation, fever and inflammation of the skin)
- Conditions in which physical exertion is contraindicated (such as cardiovascular deficits, hypertension and respiratory problems)
- Restriction in shoulder or elbow range of motion;
- Neoplasm,
Show all 11Show fewer
- Rheumatoid,
- Strength training in the past 6 months;
- Previous surgery in the spine or upper extremity;
- Complaints of pain in the shoulder, elbow,wrist, and trunk musculature system;
- Use of dietary supplements; and not in any other exercise program for at least the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Pre Application Time Intervals of Light Emitting Diode Therapy on Muscle
The purpose of this study is to determine the optimal time interval between light emitting diode application and exercise to improve fatigue resistance.The results of this study could be useful in planning a rehabilitation program in musculature disorders and also in athletic training.
Read the detailed description
- To determine the effect of light emitting diode applied 5 minutes before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
- To determine the effect of light emitting diode applied 1 hour before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
- To determine the effect of light emitting diode applied 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
- To determine the difference between light emitting diode applied 5 minutes,1 hour or 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
- Conditions
- Muscle Fatigue
- Being tested
- Light emitting diode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light emitting diodeDevice
Light emitting diode at a wavelength of 890 nm is produced by an array of 60 gallium aluminum arsenide light-emitting diodes located on flexible pads and the near infrared photo energy is delivered in a noninvasive, drug-free manner
| Study group | Role | What they receive |
|---|---|---|
| 5 minutes before 1 | Experimental | Light emitting diode applied 5 minutes before fatiguing task Receives: Device: Light emitting diode |
| 5 minutes before 2 | Placebo comparator | Light emitting diode applied 5 minutes before fatiguing task Receives: Device: Light emitting diode |
| 1 hour before 1 | Experimental | Light emitting diode applied 1 hour before fatiguing task Receives: Device: Light emitting diode |
| 1 hour before 2 | Placebo comparator | Light emitting diode applied 1 hour before fatiguing task Receives: Device: Light emitting diode |
| 5 hours before 1 | Experimental | Light emitting diode applied 5 hours before fatiguing task Receives: Device: Light emitting diode |
| 5 hours before 2 | Placebo comparator | Light emitting diode applied 5 hours before fatiguing task Receives: Device: Light emitting diode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric peak torque of elbow flexors
metric unit is Newton
Measured: change from before light emitting diode application at 5 minutes, 1 hour and 5 hours
Isometric peak torque of elbow flexors
metric unit is Newton
Measured: change from before light emitting diode application at1 minute
Isokinetic peak torque of elbow flexors
Metric unit is Newton and at angular velocity 60
Measured: change from before light emitting diode application at 5 minutes, 1 hour and 5 hours
Isokinetic peak torque of elbow flexors
Metric unit is Newton and at angular velocity 60
Measured: change from before light emitting diode application at 1 minute after light emitting diode application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Nov 2020
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAhmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367727
- Sponsor's protocol ID
- P.T.REC/012/002480
- Acronym
- LED
- Status last verified
- Nov 2020
- First submitted
- 24 Jan 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Pre Application Time Intervals of Light Emitting Diode Therapy on Muscle
- ClinicalTrials.gov ID
- NCT04367727
- Acronym / sponsor ID
- LED / P.T.REC/012/002480
- Conditions
- Muscle Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 29 Apr 2020 (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 purpose of this study is to determine the optimal time interval between light emitting diode application and exercise to improve fatigue resistance.The results of this study could be useful in planning a rehabilitation program in musculature disorders and also in athletic training.
Detailed description
- To determine the effect of light emitting diode applied 5 minutes before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
- To determine the effect of light emitting diode applied 1 hour before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
- To determine the effect of light emitting diode applied 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
- To determine the difference between light emitting diode applied 5 minutes,1 hour or 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 5 minutes before 1 | Experimental | Device: Light emitting diodeLight emitting diode applied 5 minutes before fatiguing task |
| 5 minutes before 2 | Placebo comparator | Device: Light emitting diodeLight emitting diode applied 5 minutes before fatiguing task |
| 1 hour before 1 | Experimental | Device: Light emitting diodeLight emitting diode applied 1 hour before fatiguing task |
| 1 hour before 2 | Placebo comparator | Device: Light emitting diodeLight emitting diode applied 1 hour before fatiguing task |
| 5 hours before 1 | Experimental | Device: Light emitting diodeLight emitting diode applied 5 hours before fatiguing task |
| 5 hours before 2 | Placebo comparator | Device: Light emitting diodeLight emitting diode applied 5 hours before fatiguing task |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy non athletics subjects.
- Age ranges from 20-40 years.
- Body mass index is less than 25 kg/m 2
Key exclusion criteria (11 listed)
- Neurological deficit and recent injury to either upper extremity
- non diagnosed pain .
- Contraindications to LED irradiation (such as light hypersensitivity, fluctuating blood pressure, insufficient blood circulation, fever and inflammation of the skin)
- Conditions in which physical exertion is contraindicated (such as cardiovascular deficits, hypertension and respiratory problems)
- Restriction in shoulder or elbow range of motion;
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 |
|---|---|---|
| Light emitting diodeLight emitting diode at a wavelength of 890 nm is produced by an array of 60 gallium aluminum arsenide light-emitting diodes located on flexible pads and the near infrared photo energy is delivered in a noninvasive, drug-free manner | Device | 1 hour before 1, 1 hour before 2, 5 hours before 1, 5 hours before 2, 5 minutes before 1, 5 minutes before 2 |
Primary outcome
Isometric peak torque of elbow flexors
Time frame: change from before light emitting diode application at 5 minutes, 1 hour and 5 hours
metric unit is Newton
Isometric peak torque of elbow flexors
Time frame: change from before light emitting diode application at1 minute
metric unit is Newton
Isokinetic peak torque of elbow flexors
Time frame: change from before light emitting diode application at 5 minutes, 1 hour and 5 hours
Metric unit is Newton and at angular velocity 60
Isokinetic peak torque of elbow flexors
Time frame: change from before light emitting diode application at 1 minute after light emitting diode application
Metric unit is Newton and at angular velocity 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light emitting diode in people with Muscle Fatigue, run by Cairo University at 1 site in Egypt.
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 11 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 25 Nov 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric peak torque of elbow flexors (time frame: change from before light emitting diode application at 5 minutes, 1 hour and 5 hours). The study lists 4 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 25 Nov 2020.