Muscle StrengthNCT03715920
Comparison of Different Quadriceps Femoris Isometric Strengthening Methods
A study testing Electrical currents in people with Muscle Strength, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Background:It has been reported in previous studies that more motor units are fired with electrical stimulation than voluntary muscle contraction, and even high intensity currents provide 10-30% more contractions than voluntary muscle contraction. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength
- What is being tested?
- Electrical currents
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2017to 24 Jul 2018
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Exercising regularly for the last six months.
- Presence of cardiovascular, pulmonary, orthopedic and neurological problems which may prevent exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Quadriceps Femoris Isometric Strengthening Methods in Healthy Young Women
Background:It has been reported in previous studies that more motor units are fired with electrical stimulation than voluntary muscle contraction, and even high intensity currents provide 10-30% more contractions than voluntary muscle contraction.
Objective:This study was planned to compare the effectiveness of high voltage pulsed galvanic (HVPG) stimulation, Russian current and isometric exercise on quadriceps femoris (QF) isometric muscle strength in healthy young women.
Methods:Forty-six healthy young women were included in the study (mean age=21.02 ± 1.27). Before and after the training, the dominant side QF isometric muscle strength of participants was assessed with the Isokinetic Dynamometer . The peak torque and average torques of the participants were recorded after the test. The training was planned as HVPG current for the the first group (n = 16), as Russian current for the second group (n = 15) and as isometric strengthening for the third group (n = 15). All treatments were performed under physiotherapist supervision for a total of 15 sessions for 3 days a week for 5 weeks.
Read the detailed description
Muscle strength, Isokinetic strength measurement:
The dominant side QF isometric muscle strength (torque measurements) of the participants was assessed with the Isokinetic Dynamometer . Before the test, participants were subjected to a standard warm-up of 5 minutes and evaluations were carried out using a standard seat. The back of the seat was angled 105 ° backward to provide 75 ° flexion at the body. The knee was positioned at an angle of 60 ° and was fixed with bands around the body, waist, hip and ankle. Participants had no previous experience with isokinetic dynamometer testing, therefore; it was started with a trial whose protocols were same with QF isometric muscle strength measurement protocols. Then participants QF isometric muscle strength was measured by three 10-second maximal isometric contraction. Rest periods of 3 seconds between each contraction were given. Each participant held the sides of the seat with both hands during the test. Verbal encouragement was made throughout the whole test to obtain maximum strength from the participants. The peak torque and average torques of the participants were recorded after the test.
High Voltage Pulsed Galvanic Current:
The instrument was automatically set to a pulse rate of 100 μs while the pulse frequency was set to 60 pulses / sec. In order to avoid fatigue, the intermittant form of the current was selected and the transition time / rest time was set to 4 sec. impulse / 12 sec. The total output voltage of the device ranged from 0 to 500 volts and the current intensity was increased until the sensible contraction of the applied muscle was achieved without causing too much sense of discomfort. Stimulation was performed after the body and knee were positioned and stabilized at 75 ° flexion and 60 ° flexion angle, respectively. One of the 6 * 8 cm carbonated electrodes was placed in the distal portion of the vastus medialis, while the other one was placed in the proximal portion of the vastus lateralis. This placement was intended to stimulate a large proportion of the muscle fibers of the QF muscle.The HVPG was applied for a total of 20 minutes. Current intensity was increased to obtain optimal muscle contraction.
Russian Current In the treatment with the Russian current, a protocol developed by Kots, also known in the literature as "Russian Technique", was used. In the treatment with the Russian movement, a protocol developed by Kots, also known as "Russian Technique", was used in the literature. There were 10 muscle contractions per treatment session in this protocol. Each contraction lasted for 10 seconds and a resting time of 50 seconds were given for the next contraction (transition: rest ratio was 1/5).The position of the participants in the application and the placement of the electrodes were same as the the other application. Current intensity was increased until tetanic muscle contraction was obtained.
Isometric Exercise:
The body and knee of the participants in the isometric exercise group were positioned and stabilized at 75 ° flexion and 60 ° flexion angle, respectively as in the stimulation groups. Participants were asked to do 10 repetitions as 10 seconds of maximum voluntary contractions and 10 seconds of rest.
- Conditions
- Muscle Strength
- Being tested
- Electrical currents
- Keywords
- Quadriceps femoris, isometric form, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical currentsDevice
Also called Exercises, Isometric
The training was planned as HVPG current for the the first group (n = 16), as Russian current for the second group (n = 15) and as isometric strengthening for the third group (n = 15). All treatments were performed under physiotherapist supervision for a total of 15 sessions for 3 days a week for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Voltage Pulsed Galvanic Current | Active comparator | HVPG current is a new form of neuromuscular electrical stimulation.The total output voltage of the device ranged from 0 to 500 volts and the current intensity was increased until the sensible contraction of the applied muscle was achieved without causing too much sense of discomfort Receives: Device: Electrical currents |
| Russian Current | Placebo comparator | Russian currents are a high frequency current of 2500 Hz and reduce the resistance of the skin and it would penetrate deeper and reach deeper motor nerves.Russian movement, a protocol developed by Kots, also known as "Russian Technique", was used in the literature. There were 10 muscle contractions per treatment session in this protocol. Each contraction lasted for 10 seconds and a resting time of 50 seconds were given for the next contraction (transition: rest ratio was 1/5). Receives: Device: Electrical currents |
| Isometric Exercise | Sham comparator | Isometric or static strength training is exercises performed without joint movement and changing muscle length during muscle contraction.
The body and knee of the participants in the isometric exercise group were positioned and stabilized at 75 ° flexion and 60 ° flexion angle, respectively as in the stimulation groups. Participants were asked to do 10 repetitions as 10 seconds of maximum voluntary contractions and 10 seconds of rest. Receives: Device: Electrical currents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic Strength measurement
Muscle strength, Isokinetic strength measurement:
The dominant side QF isometric muscle strength (torque measurements) of the participants was assessed with the Isokinetic Dynamometer (Humac Norm Testing Rehabilitation System, CSMI Medical Solutions, USA).
Measured: One week
Secondary outcomes (1)
Isometric exercise
The body and knee of the participants in the isometric exercise group were positioned and stabilized at 75 ° flexion and 60 ° flexion angle, respectively as in the stimulation groups
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start24 Sep 2017
- Primary completion24 Nov 2017
- Study completion24 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Basakci Calik, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715920
- Sponsor's protocol ID
- 60116787-020/77612
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 23 Oct 2018
- 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 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Quadriceps Femoris Isometric Strengthening Methods in Healthy Young Women
- ClinicalTrials.gov ID
- NCT03715920
- Acronym / sponsor ID
- 60116787-020/77612
- Conditions
- Muscle Strength
- Keywords
- Quadriceps femoris, isometric form, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 24 Sep 2017 (actual)
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 23 Oct 2018 (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.
Background:It has been reported in previous studies that more motor units are fired with electrical stimulation than voluntary muscle contraction, and even high intensity currents provide 10-30% more contractions than voluntary muscle contraction.
Objective:This study was planned to compare the effectiveness of high voltage pulsed galvanic (HVPG) stimulation, Russian current and isometric exercise on quadriceps femoris (QF) isometric muscle strength in healthy young women.
Methods:Forty-six healthy young women were included in the study (mean age=21.02 ± 1.27). Before and after the training, the dominant side QF isometric muscle strength of participants was assessed with the Isokinetic Dynamometer . The peak torque and average torques of the participants were recorded after the test. The training was planned as HVPG current for the the first group (n = 16), as Russian current for the second group (n = 15) and as isometric strengthening for the third group (n = 15). All treatments were performed under physiotherapist supervision for a total of 15 sessions for 3 days a week for 5 weeks.
Detailed description
Muscle strength, Isokinetic strength measurement:
The dominant side QF isometric muscle strength (torque measurements) of the participants was assessed with the Isokinetic Dynamometer . Before the test, participants were subjected to a standard warm-up of 5 minutes and evaluations were carried out using a standard seat. The back of the seat was angled 105 ° backward to provide 75 ° flexion at the body. The knee was positioned at an angle of 60 ° and was fixed with bands around the body, waist, hip and ankle. Participants had no previous experience with isokinetic dynamometer testing, therefore; it was started with a trial whose protocols were same with QF isometric muscle strength measurement protocols. Then participants QF isometric muscle strength was measured by three 10-second maximal isometric contraction. Rest periods of 3 seconds between each contraction were given. Each participant held the sides of the seat with both hands during the test. Verbal encouragement was made throughout the whole test to obtain maximum strength from the participants. The peak torque and average torques of the participants were recorded after the test.
High Voltage Pulsed Galvanic Current:
The instrument was automatically set to a pulse rate of 100 μs while the pulse frequency was set to 60 pulses / sec. In order to avoid fatigue, the intermittant form of the current was selected and the transition time / rest time was set to 4 sec. impulse / 12 sec. The total output voltage of the device ranged from 0 to 500 volts and the current intensity was increased until the sensible contraction of the applied muscle was achieved without causing too much sense of discomfort. Stimulation was performed after the body and knee were positioned and stabilized at 75 ° flexion and 60 ° flexion angle, respectively. One of the 6 * 8 cm carbonated electrodes was placed in the distal portion of the vastus medialis, while the other one was placed in the proximal portion of the vastus lateralis. This placement was intended to stimulate a large proportion of the muscle fibers of the QF muscle.The HVPG was applied for a total of 20 minutes. Current intensity was increased to obtain optimal muscle contraction.
Russian Current In the treatment with the Russian current, a protocol developed by Kots, also known in the literature as "Russian Technique", was used. In the treatment with the Russian movement, a protocol developed by Kots, also known as "Russian Technique", was used in the literature. There were 10 muscle contractions per treatment session in this protocol. Each contraction lasted for 10 seconds and a resting time of 50 seconds were given for the next contraction (transition: rest ratio was 1/5).The position of the participants in the application and the placement of the electrodes were same as the the other application. Current intensity was increased until tetanic muscle contraction was obtained.
Isometric Exercise:
The body and knee of the participants in the isometric exercise group were positioned and stabilized at 75 ° flexion and 60 ° flexion angle, respectively as in the stimulation groups. Participants were asked to do 10 repetitions as 10 seconds of maximum voluntary contractions and 10 seconds of rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Voltage Pulsed Galvanic Current | Active comparator | Device: Electrical currentsHVPG current is a new form of neuromuscular electrical stimulation.The total output voltage of the device ranged from 0 to 500 volts and the current intensity was increased until the sensible contraction of the applied muscle was achieved without causing too much sense of discomfort |
| Russian Current | Placebo comparator | Device: Electrical currentsRussian currents are a high frequency current of 2500 Hz and reduce the resistance of the skin and it would penetrate deeper and reach deeper motor nerves.Russian movement, a protocol developed by Kots, also known as "Russian Technique", was used in the literature. There were 10 muscle contractions per treatment session in this protocol. Each contraction lasted for 10 seconds and a resting time of 50 seconds were given for the next contraction (transition: rest ratio was 1/5). |
| Isometric Exercise | Sham comparator | Device: Electrical currentsIsometric or static strength training is exercises performed without joint movement and changing muscle length during muscle contraction. The body and knee of the participants in the isometric exercise group were positioned and stabilized at 75 ° flexion and 60 ° flexion angle, respectively as in the stimulation groups. Participants were asked to do 10 repetitions as 10 seconds of maximum voluntary contractions and 10 seconds of rest. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Exercising regularly for the last six months.
- Presence of cardiovascular, pulmonary, orthopedic and neurological problems which may prevent exercise.
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 currentsAlso: Exercises, IsometricThe training was planned as HVPG current for the the first group (n = 16), as Russian current for the second group (n = 15) and as isometric strengthening for the third group (n = 15). All treatments were performed under physiotherapist supervision for a total of 15 sessions for 3 days a week for 5 weeks. | Device | High Voltage Pulsed Galvanic Current, Isometric Exercise, Russian Current |
Primary outcome
Isokinetic Strength measurement
Time frame: One week
Muscle strength, Isokinetic strength measurement: The dominant side QF isometric muscle strength (torque measurements) of the participants was assessed with the Isokinetic Dynamometer (Humac Norm Testing Rehabilitation System, CSMI Medical Solutions, USA).
1 secondary outcome
Isometric exercise
Time frame: One week
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 23 Oct 2018.
- 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.
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 Electrical currents in people with Muscle Strength, run by Pamukkale 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 0 inclusion and 2 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 23 Oct 2018. 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?
Isokinetic Strength measurement (time frame: One week). 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 23 Oct 2018.