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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Bilge Basakci Calik

    Kınıklı, 20000

Other trials in Turkey (Türkiye)

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 groups in NCT03715920
Study groupRoleWhat they receive
High Voltage Pulsed Galvanic CurrentActive comparatorHVPG 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 CurrentPlacebo comparatorRussian 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 ExerciseSham comparatorIsometric 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.

  1. 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)
  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.

  1. First posted23 Oct 2018
  2. Study start24 Sep 2017
  3. Primary completion24 Nov 2017
  4. Study completion24 Jul 2018

Resources

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)
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

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.

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