NCT03715920

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

October 11, 2018

Last Update Submit

October 19, 2018

Conditions

Keywords

Quadriceps femorisisometric formexercise

Outcome Measures

Primary Outcomes (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).

    One week

Secondary Outcomes (1)

  • Isometric exercise

    One week

Study Arms (3)

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

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).

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.

Device: Electrical currents

Interventions

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.

Also known as: Exercises, Isometric
High Voltage Pulsed Galvanic CurrentIsometric ExerciseRussian Current

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Not having knee complaints such as pain, lockout, morning arrest, swelling, difficulty in walking.
  • Not having any orthopedic or neurological disability

You may not qualify if:

  • Exercising regularly for the last six months.
  • Presence of cardiovascular, pulmonary, orthopedic and neurological problems which may prevent exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilge Basakci Calik

Kınıklı, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise TherapyMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 23, 2018

Study Start

September 24, 2017

Primary Completion

November 24, 2017

Study Completion

July 24, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations