Quality of LifeNCT05303181
The Effect of Different Russian Current Parameters on MVIC Contraction of the Quadriceps Muscle Among University of Sharjah Students.
A study testing Russian Current in people with Quality of Life, run by University of Sharjah.
Trial summary
The study aims to investigate the effect of different Russian current parameters on maximum voluntary isometric contraction of the quadriceps muscle among University of Sharjah students. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Russian Current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2022to 30 Apr 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Their age ranged from 18 to 25 years.
- Their Body Mass Index (BMI) within normal range (18.5-25).
- Don't have any health related condition that required medical attention in the past two years.
- All participant at same physical fitness level.
Who cannot join
- The subjects will be excluded from this study if they have any of the following criteria:
- Quadriceps muscle injury.
- Spinal or lower limb fractures.
- Lower limb deformities.
- Associated cognition abnormalities which may to affect muscle and limb function
- Tumors or radicular symptoms
Show all 9Show fewer
- Recent muscular lesion, knee injury, sensory changes and neuromuscular disease
- Previous surgery that may affect the lower limb muscle performance.
- Any contraindication for Russian current application
About this study
Official title: The Effect of Different Russian Current Parameters on Maximum Voluntary Isometric Contraction(MVIC) of the Quadriceps Muscle Among University of Sharjah Students: A Randomized Controlled Trail.
The study aims to investigate the effect of different Russian current parameters on maximum voluntary isometric contraction of the quadriceps muscle among University of Sharjah students.
Read the detailed description
Muscular strength and endurance are two important compatible parts of the body; for normal people to move, lift things and do day-to-day activities or athletic performance. Large number of studies have been carried out to elaborate the different factor that help in improving the muscular strength as well as the endurance combined with rehabilitation programs in order to promote muscle function and prevent the injury(Akinoglu \& Kocahan, 2020; Chou \& Binder-Macleod, 2007; Evetovich et al., 2001; Selkowitz, 1985; Snyder-Mackler et al., 1994; Ward et al., 2006). Strengthening and endurance training have been used frequently in varied rehabilitation protocols in order to improve the overall musculoskeletal performance.(Earl \& Hoch, 2011; Gondin et al., 2011). Meanwhile, Isokinetic training and Neuromuscular electrical stimulation are frequently utilized in physical therapy.(Brown \& Whitehurst, 2003; Chou \& Binder-Macleod, 2007; Evetovich et al., 2001; Stone, 1997).
Russian current is one of the popular preferred Neuromuscular electrical stimulation as it has been advocated to increase muscle strength due to its high tolerance as well as minimum pain level provocation (Akinoglu \& Kocahan, 2020; Gondin et al., 2011). Russian currents are alternating currents at a frequency of 2.5 kHz that are burst modulated at a frequency of 50 Hz with a 50% duty cycle. The widely and most popular training protocol used with Russian current is (10/50/10) in which the stimulus is applied for a 10-second "on" period followed by a 50-second "off" or rest period, with a recommended treatment time of 10 minutes per stimulation session. Russian currents are used mainly to generate a motor response, but it also has been investigated as an electro-analgesia type intervention. This training protocol is used mainly to generate a motor response, but it also has been investigated as an electro-analgesia type intervention.
Despite a lot of previous research regarding the Russian current; no studies are available in which suggest the most efficient carrier frequency for Russian current to strengthening the muscles and increase muscle with isokinetic training in the short term and the effect of different RC on the EIT by the quadriceps muscle. The aim of this study is directed toward investigation of those different Russian current carrier frequencies' effects on the quadriceps muscle isokinetic strength and endurance in addition to investigate the effect of different mode of RC on the EIT by the quadriceps femoris muscle. This study will include measurement for the knee torque and quadriceps muscle strength using Biodex system 3 that will be generated by different carrier frequency in addition to different RC mode, and investigate the relationship between those variables.
- Conditions
- Quality of Life
- Being tested
- Russian Current
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Russian CurrentDevice
Also called The Biodex isokinetic dynamometer
The patient will be placed in sitting position, hip at 90-degree flexion, knee at 60°, the upper body supported by the backrest, cross belt support the trunk and cross belt support the pelvis. The dynamometer rotating axis will be aligned with knee joint axis and the resistance lever arm will place in the distal leg above the malleolus. The angle of the joints adjustment considering the joint's range of motion and the device's user's manual, any movement other than the range of motion determined by the mechanical limit will be not allowed
All electrical induced contraction will last 4 second each, with characteristics of 75 bursts; 4 second time on, 400 μs pulse width and 10 second time off. The greatest electrically induced torque by the quadriceps muscle at the maximum current output from the stimulator will be recorded for each subject to be used in data analysis. The same procedure will be done on the 3rd week and after 6th week.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | training used Russian Current carrier frequency at 2500-Hz alternating current. Receives: Device: Russian Current |
| Group2 | Experimental | training used Russian Current carrier frequency at 3750-Hz alternating current. Receives: Device: Russian Current |
| Group3 | Experimental | training used Russian Current carrier frequency at 5000-Hz alternating current. Receives: Device: Russian Current |
| Group4 | Experimental | training used Russian Current at different mode. Receives: Device: Russian Current |
What is being measured
The primary outcome is the main question the study is designed to answer.
establish the relationship between the different carrier frequency for burst modulated electrical stimulation as an independent variable and electrical induced quadriceps femoris muscle torque (EIT) as a dependent variable.
The primary outcome of the study is to establish the relationship between the different carrier frequency for burst modulated electrical stimulation as an independent variable and electrical induced quadriceps femoris muscle torque (EIT) as a dependent variable.
And the effect of different RC mode on the electrical induce torque by the quadriceps muscle. The EIT measurement will be done using the Biodex pro 3 system devices this system was described in detail; with reliability and validity has been investigated previous study establish its reliable. This study, will investigate the effect of different carrier frequency 2500Hz-3750Hz-5000Hz alternating current on the electrical induce quadriceps muscle torque of the dominant leg, and the effect of different Russian current mode on the EIT of the quadriceps muscle femoris.
Measured: measured data will be recorded at the 3rd week after training using RC and at 6th week as a follow up measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start8 May 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ansam Tayseer Hasan, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303181
- Sponsor's protocol ID
- REC-21-02-18-01-S
- Status last verified
- Mar 2022
- First submitted
- 22 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information taken will be kept confidential and will not be taken without the participant's consent. Any data collected will be for scientific purpose only.The therapists have been instructed about the privacy, confidentiality and rights of the participants . Published data will remain anonymous without personal identifier of participants
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Russian Current Parameters on Maximum Voluntary Isometric Contraction(MVIC) of the Quadriceps Muscle Among University of Sharjah Students: A Randomized Controlled Trail.
- ClinicalTrials.gov ID
- NCT05303181
- Acronym / sponsor ID
- REC-21-02-18-01-S
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 8 May 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 31 Mar 2022 (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 study aims to investigate the effect of different Russian current parameters on maximum voluntary isometric contraction of the quadriceps muscle among University of Sharjah students.
Detailed description
Muscular strength and endurance are two important compatible parts of the body; for normal people to move, lift things and do day-to-day activities or athletic performance. Large number of studies have been carried out to elaborate the different factor that help in improving the muscular strength as well as the endurance combined with rehabilitation programs in order to promote muscle function and prevent the injury(Akinoglu \& Kocahan, 2020; Chou \& Binder-Macleod, 2007; Evetovich et al., 2001; Selkowitz, 1985; Snyder-Mackler et al., 1994; Ward et al., 2006). Strengthening and endurance training have been used frequently in varied rehabilitation protocols in order to improve the overall musculoskeletal performance.(Earl \& Hoch, 2011; Gondin et al., 2011). Meanwhile, Isokinetic training and Neuromuscular electrical stimulation are frequently utilized in physical therapy.(Brown \& Whitehurst, 2003; Chou \& Binder-Macleod, 2007; Evetovich et al., 2001; Stone, 1997).
Russian current is one of the popular preferred Neuromuscular electrical stimulation as it has been advocated to increase muscle strength due to its high tolerance as well as minimum pain level provocation (Akinoglu \& Kocahan, 2020; Gondin et al., 2011). Russian currents are alternating currents at a frequency of 2.5 kHz that are burst modulated at a frequency of 50 Hz with a 50% duty cycle. The widely and most popular training protocol used with Russian current is (10/50/10) in which the stimulus is applied for a 10-second "on" period followed by a 50-second "off" or rest period, with a recommended treatment time of 10 minutes per stimulation session. Russian currents are used mainly to generate a motor response, but it also has been investigated as an electro-analgesia type intervention. This training protocol is used mainly to generate a motor response, but it also has been investigated as an electro-analgesia type intervention.
Despite a lot of previous research regarding the Russian current; no studies are available in which suggest the most efficient carrier frequency for Russian current to strengthening the muscles and increase muscle with isokinetic training in the short term and the effect of different RC on the EIT by the quadriceps muscle. The aim of this study is directed toward investigation of those different Russian current carrier frequencies' effects on the quadriceps muscle isokinetic strength and endurance in addition to investigate the effect of different mode of RC on the EIT by the quadriceps femoris muscle. This study will include measurement for the knee torque and quadriceps muscle strength using Biodex system 3 that will be generated by different carrier frequency in addition to different RC mode, and investigate the relationship between those variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Device: Russian Currenttraining used Russian Current carrier frequency at 2500-Hz alternating current. |
| Group2 | Experimental | Device: Russian Currenttraining used Russian Current carrier frequency at 3750-Hz alternating current. |
| Group3 | Experimental | Device: Russian Currenttraining used Russian Current carrier frequency at 5000-Hz alternating current. |
| Group4 | Experimental | Device: Russian Currenttraining used Russian Current at different mode. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Their age ranged from 18 to 25 years.
- Their Body Mass Index (BMI) within normal range (18.5-25).
- Don't have any health related condition that required medical attention in the past two years.
- All participant at same physical fitness level.
Key exclusion criteria (9 listed)
- The subjects will be excluded from this study if they have any of the following criteria:
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 |
|---|---|---|
| Russian CurrentAlso: The Biodex isokinetic dynamometerThe patient will be placed in sitting position, hip at 90-degree flexion, knee at 60°, the upper body supported by the backrest, cross belt support the trunk and cross belt support the pelvis. The dynamometer rotating axis will be aligned with knee joint axis and the resistance lever arm will place in the distal leg above the malleolus. The angle of the joints adjustment considering the joint's range of motion and the device's user's manual, any movement other than the range of motion determined by the mechanical limit will be not allowed All electrical induced contraction will last 4 second each, with characteristics of 75 bursts; 4 second time on, 400 μs pulse width and 10 second time off. The greatest electrically induced torque by the quadriceps muscle at the maximum current output from the stimulator will be recorded for each subject to be used in data analysis. The same procedure will be done on the 3rd week and after 6th week. | Device | Group1, Group2, Group3, Group4 |
Primary outcome
establish the relationship between the different carrier frequency for burst modulated electrical stimulation as an independent variable and electrical induced quadriceps femoris muscle torque (EIT) as a dependent variable.
Time frame: measured data will be recorded at the 3rd week after training using RC and at 6th week as a follow up measurements
The primary outcome of the study is to establish the relationship between the different carrier frequency for burst modulated electrical stimulation as an independent variable and electrical induced quadriceps femoris muscle torque (EIT) as a dependent variable. And the effect of different RC mode on the electrical induce torque by the quadriceps muscle. The EIT measurement will be done using the Biodex pro 3 system devices this system was described in detail; with reliability and validity has been investigated previous study establish its reliable. This study, will investigate the effect of different carrier frequency 2500Hz-3750Hz-5000Hz alternating current on the electrical induce quadriceps muscle torque of the dominant leg, and the effect of different Russian current mode on the EIT of the quadriceps muscle femoris.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No. All information taken will be kept confidential and will not be taken without the participant's consent. Any data collected will be for scientific purpose only.The therapists have been instructed about the privacy, confidentiality and rights of the participants . Published data will remain anonymous without personal identifier of participants
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Russian Current in people with Quality of Life, run by University of Sharjah.
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 4 inclusion and 9 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
establish the relationship between the different carrier frequency for burst modulated electrical stimulation as an independent variable and electrical induced quadriceps femoris muscle torque (EIT) as a dependent variable. (time frame: measured data will be recorded at the 3rd week after training using RC and at 6th week as a follow up measurements). 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 31 Mar 2022.