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- Klinische proef NCT03409575
Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population
Efficacy of Two Different Method of Neuromuscular Electrical Stimulation on Quadriceps Strength, Fatigue and Physical Function in Geriatric Population
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ordu, Kalkoen, 52100
- Sevim ACARÖZ CANDAN
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Altinordu
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Ordu, Altinordu, Kalkoen, 52100
- Sevim ACARÖZ CANDAN
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria includes
- age 60 years or older
- be able to climb one floor of stairs independently
- not participate in an exercise program to increase strength or physiotherapy programme.
Exclusion Criteria:
- having a medical condition in which NMES training is contraindicated
- having a cognitive impairment
- having implanted cardiac pacemaker
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 5 minutes stimulation
The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 5 minutes.
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Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes.
NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.).
Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions).
Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 5 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes.
5 minutes of NMES will be made in 4 sets.
Fifteen contractions will be received at each set.
The intensity of the current will be increased until the visible contraction is taken.
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Ander: 10 minutes stimulation
The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 10 minutes.
|
Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes.
NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.).
Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions).
Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 10 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes.
10 minutes of NMES will be made in 2 sets.
Thirty contractions will be received at each set.
The intensity of the current will be increased until the visible contraction is taken.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Timed up and go test
Tijdsspanne: 2 minutes
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This test will be used to measure the progress of balance, sit to stand, and walking. The participants stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Time will be recorded. |
2 minutes
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30-Second Chair Stand Test
Tijdsspanne: 30 second
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The 30CST is a measurement that assesses functional lower extremity strength in older adults.
The participant is encouraged to complete as many full stands as possible within 30 seconds.
The participant is instructed to fully sit between each stand.The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).
Incorrectly executed stands are not counted.
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30 second
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6 minute walk test
Tijdsspanne: 6 minute
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The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
The participant walk for 6 minutes on 30 meter long way.
The total distance will be recorded at the end of the test.
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6 minute
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Grip Strength
Tijdsspanne: 5 minutes
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The patient wiil squeeze the dynamometer as the arm is adjacent to the body, the elbow is at 90 ° flexion, the forearm is in the neutral position and the wrist is at 0-30 ° extension.
After the test is repeated three times, the highest score will be recorded.
The test will only be done for the dominant hand.
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5 minutes
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Berg Balance Scale
Tijdsspanne: 10 minutes
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The balance will be evaluated observational during 14 different balance activities. A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. It's minimum and maximum scores ranged between 0 and 56. Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk |
10 minutes
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Strength of Quadriceps muscle
Tijdsspanne: 5 minutes.
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Lafayette manuel muscle tester will be used to determine the strength of the Quadriceps.
The strength will be evaluated bilaterally three times and then the maximum value will be recorded.
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5 minutes.
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Short Physical Performance Battery
Tijdsspanne: 3 minutes
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The battery is an objective assessment tool for evaluating lower extremity functioning in older persons.
The battery is scored between 0-12 scores according to the balance, chair stand test performance and gait speed of the participant.
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3 minutes
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Fatigue Severity Scale
Tijdsspanne: 5 minutes
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The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
Each item is scored between1 and 7. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement.
A total score of 36 or more suggests that you may be suffering from the fatigue.
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5 minutes
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sevim A CANDAN, T.C. ORDU ÜNİVERSİTESİ
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AR-1665
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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