Sports InjuryNCT06300385
Effect of EMS and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes
A study testing Electromyostimulation and Strengthening exercises in people with Sports Injury, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Injury
- What is being tested?
- Electromyostimulation and Strengthening exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jul 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having at least 5 years of professional motocross training experience
- Being between 18 and 30 years old
- Volunteering to participate in the study
Who cannot join
- To be absent from the 6-week EMS and strengthening program for more than 2 consecutive sessions
- Having suffered any injury that prevents you from training in the last 6 months
- Being receiving a physiotherapy program other than the protocol to be used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Electromyostimulation and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes
Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes.
Read the detailed description
Motocross is a popular sport in which participants ride a two-wheeled, motorized vehicle around a 2 km rugged track with natural or man-made obstacles. Participants race at high speeds and it is considered a strenuous sport with a high accident rate. Motocross racers grip the handlebars of their bikes with both hands throughout the race, which lasts between 18 and 26 minutes. Therefore, it is a sports branch where control is concentrated on the arms and upper extremities. It has been reported that the most frequently injured and painful area is the forearm. Therefore, good and strong upper extremity and forearm control is important for the prevention of injuries or subsequent recovery processes.
It is known that strengthening exercise programs are used in physiotherapy practices to improve strength and stabilization parameters. The use of electromyostimulation applications for strengthening in different populations is also becoming widespread.
There are no studies demonstrating the effectiveness of strengthening and electromyostimulation applications on pain, fatigue and strength parameters in motocross athletes.
The aim of this study is to compare the effectiveness of electromyostimulation application applied simultaneously with a strengthening exercise program on pain, fatigue and strength, with strengthening exercises performed with sham application (electric current turned off).
- Conditions
- Sports Injury
- Being tested
- Electromyostimulation, Strengthening exercises
- Keywords
- sports, electromyostimulation, exercise, pain, fatigue, strength
- Medical subject headings
- Athletic Injuries, Motor Activity, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyostimulationDevice
Electromyostimulation (EMS), a low-frequency current, will be used for electrical stimulation of the wrist flexor muscle group. Stimulation frequency will be applied as 25 Hertz. Care will be taken to ensure that the current intensity does not cause pain in the patient. The size of the EMS electrodes is 2 cm2 and they will be placed in the form of 4 electrodes on the wrist flexor muscles (inner wrist area) with a distance of 1 cm between them. Each strengthening session will be 15 minutes for 6 weeks, 3 days a week, for a total of 18 sessions. EMS application will be carried out together with strengthening exercises. Laica MD6078 branded device belonging to the researchers will be used.
Strengthening exercisesOther
All participants will do resistance exercises for strengthening, 3 sessions per week for 6 weeks. Each movement will be performed in 3 sets and 12 repetitions according to the planned intensity. Wrist curl, reverse wrist curl movements (with 10kg dumbbells) and power web flex grip movements will be applied simultaneously with EMS application. The program will last 15 minutes in total.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | These participants will receive electromyostimulation simultaneously with strengthening exercise. Receives: Device: Electromyostimulation; Other: Strengthening exercises |
| Sham control | Sham comparator | These participants will receive sham electromyostimulation (current turned off) simultaneously with strengthening exercise. Receives: Other: Strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Pain assessment: Pain scores of patients will be recorded using 0-100 mm Visual Analog Scale (VAS) to grade pain. For VAS; A measured horizontal line will be created, and definitions such as 'no symptoms' and 'severe symptoms' will be written at both ends. The participant will be instructed to mark a point on the line appropriate to the severity of the symptom. Wrist pain values in the resting position will be recorded before and after the 6-week program.
Measured: 6 week
Strength measurement
Lafayette Dynamometer: Lafayette Manual Muscle Testing device will be used to evaluate muscle strength. While the measurements are being made, the device will be kept stationary and the resistance given by the participant will be measured in Newtons. Measurements will be made in the sitting position for wrist flexion/extension and forearm flexion, and total muscle strength will be recorded.
Measured: 6 week
Fatigue assessment
Fatigue Severity Scale: The fatigue level of the participants will be evaluated with the Fatigue Severity Scale. It is a survey with 9 questions and 8-point Likert form.A high score means a high level of fatigue.
Measured: 6 week
Grip strength assessment
Jamar Hand Grip Dynamometer will be used to evaluate hand grip and finger flexor muscle strength. The participant will sit upright during the assessment. Elbow and knee angle will be 90 degrees. A full force grip will be required with the wrist in the neural position. The measurement will be performed 3 times with an interval of 10 seconds. Increasing values will indicate higher strength. Measurement results will be recorded in kilograms and pounds.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports InjuryStudies 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
- Parallel groups
- Model description
- 2 parallel groups randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Çakır, Istanbul Bilgi University
- Investigators
- Hulya Sisli, PhD, Study director, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300385
- Sponsor's protocol ID
- IstanbulBUFC5
- Status last verified
- Jul 2024
- First submitted
- 3 Mar 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electromyostimulation and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes
- ClinicalTrials.gov ID
- NCT06300385
- Acronym / sponsor ID
- IstanbulBUFC5
- Conditions
- Sports Injury
- Keywords
- sports, electromyostimulation, exercise, pain, fatigue, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 8 Mar 2024 (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.
Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes.
Detailed description
Motocross is a popular sport in which participants ride a two-wheeled, motorized vehicle around a 2 km rugged track with natural or man-made obstacles. Participants race at high speeds and it is considered a strenuous sport with a high accident rate. Motocross racers grip the handlebars of their bikes with both hands throughout the race, which lasts between 18 and 26 minutes. Therefore, it is a sports branch where control is concentrated on the arms and upper extremities. It has been reported that the most frequently injured and painful area is the forearm. Therefore, good and strong upper extremity and forearm control is important for the prevention of injuries or subsequent recovery processes.
It is known that strengthening exercise programs are used in physiotherapy practices to improve strength and stabilization parameters. The use of electromyostimulation applications for strengthening in different populations is also becoming widespread.
There are no studies demonstrating the effectiveness of strengthening and electromyostimulation applications on pain, fatigue and strength parameters in motocross athletes.
The aim of this study is to compare the effectiveness of electromyostimulation application applied simultaneously with a strengthening exercise program on pain, fatigue and strength, with strengthening exercises performed with sham application (electric current turned off).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 parallel groups randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Electromyostimulation, Other: Strengthening exercisesThese participants will receive electromyostimulation simultaneously with strengthening exercise. |
| Sham control | Sham comparator | Other: Strengthening exercisesThese participants will receive sham electromyostimulation (current turned off) simultaneously with strengthening exercise. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having at least 5 years of professional motocross training experience
- Being between 18 and 30 years old
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- To be absent from the 6-week EMS and strengthening program for more than 2 consecutive sessions
- Having suffered any injury that prevents you from training in the last 6 months
- Being receiving a physiotherapy program other than the protocol to be used in the study
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 |
|---|---|---|
| ElectromyostimulationElectromyostimulation (EMS), a low-frequency current, will be used for electrical stimulation of the wrist flexor muscle group. Stimulation frequency will be applied as 25 Hertz. Care will be taken to ensure that the current intensity does not cause pain in the patient. The size of the EMS electrodes is 2 cm2 and they will be placed in the form of 4 electrodes on the wrist flexor muscles (inner wrist area) with a distance of 1 cm between them. Each strengthening session will be 15 minutes for 6 weeks, 3 days a week, for a total of 18 sessions. EMS application will be carried out together with strengthening exercises. Laica MD6078 branded device belonging to the researchers will be used. | Device | Experimental |
| Strengthening exercisesAll participants will do resistance exercises for strengthening, 3 sessions per week for 6 weeks. Each movement will be performed in 3 sets and 12 repetitions according to the planned intensity. Wrist curl, reverse wrist curl movements (with 10kg dumbbells) and power web flex grip movements will be applied simultaneously with EMS application. The program will last 15 minutes in total. | Other | Experimental, Sham control |
Primary outcome
Visual analog scale
Time frame: 6 week
Pain assessment: Pain scores of patients will be recorded using 0-100 mm Visual Analog Scale (VAS) to grade pain. For VAS; A measured horizontal line will be created, and definitions such as 'no symptoms' and 'severe symptoms' will be written at both ends. The participant will be instructed to mark a point on the line appropriate to the severity of the symptom. Wrist pain values in the resting position will be recorded before and after the 6-week program.
Strength measurement
Time frame: 6 week
Lafayette Dynamometer: Lafayette Manual Muscle Testing device will be used to evaluate muscle strength. While the measurements are being made, the device will be kept stationary and the resistance given by the participant will be measured in Newtons. Measurements will be made in the sitting position for wrist flexion/extension and forearm flexion, and total muscle strength will be recorded.
Fatigue assessment
Time frame: 6 week
Fatigue Severity Scale: The fatigue level of the participants will be evaluated with the Fatigue Severity Scale. It is a survey with 9 questions and 8-point Likert form.A high score means a high level of fatigue.
Grip strength assessment
Time frame: 6 week
Jamar Hand Grip Dynamometer will be used to evaluate hand grip and finger flexor muscle strength. The participant will sit upright during the assessment. Elbow and knee angle will be 90 degrees. A full force grip will be required with the wrist in the neural position. The measurement will be performed 3 times with an interval of 10 seconds. Increasing values will indicate higher strength. Measurement results will be recorded in kilograms and pounds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Hulya Sisli, PhD study director
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyostimulation and Strengthening exercises in people with Sports Injury, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 5 Jul 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analog scale (time frame: 6 week). 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 5 Jul 2024.