Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population
21 de marzo de 2018 actualizado por: Sevim ACARÖZ CANDAN
Efficacy of Two Different Method of Neuromuscular Electrical Stimulation on Quadriceps Strength, Fatigue and Physical Function in Geriatric Population
The decline in physical function and strength was seen by the nature of aging.
The older adults often complain of fatigue.
For these reasons, proper rehabilitation approaches should be used to ensure healthy life and to keep the quality of life at the highest possible level by minimizing the decline seen with aging process.
Exercise programs and Neuromuscular Electrical Stimulation (NMES) are applied in rehabilitation to restore muscular strength and improve physical performance.
NMES is used to prevent the atrophy of nonuse, to increase joint range of motion, to re-educate muscle, to regulate spasticity, to replace orthosis, to improve motor involvement of muscle fibers.
Despite the use of NMES for strengthening in the clinics, the application parameters and methods should be discussed.
The frequency, the pulse duration, the on / off time, the amplitude, the waveform of the current and the application time vary between the studies.
For geriatric populations, it is recommended that the highest intensity, biphasic symmetrical currents with a frequency in the range of 50-100 Hz, for 100-400 μs, can be pulsed for ideal amplification.
NMES is usually practiced by physiotherapists continuously for 20 minutes in to strengthen.
However, in recent studies, it has been shown that continuous application of a single-session 100 Hz current for 20 minutes leads to intense fatigue and after a while the effect of the strengthening of the current has been removed.
Therefore, intermittent applications have been proposed instead of continuous applications for 20 minutes.
Considering the fragility and the presence of sarcopenia in the geriatric population, NMES applications should be preferred in which rest periods are given instead of continuous application for 20 minutes.
In the literature, there is no study showing the effect of NMES on Quadriceps strength, fatigue and physical function by using quadriceps stimulation for 20 minutes using different stimulation periods.Therefore, in this study, will be investigated the possible effects of two different methods of NMES on Quadriceps strength, fatigue and physical function.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ordu, Pavo, 52100
- Sevim ACARÖZ CANDAN
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Altinordu
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Ordu, Altinordu, Pavo, 52100
- Sevim ACARÖZ CANDAN
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
65 años a 95 años (Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: 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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Otro: 10 minutes stimulation
The biphasic, symmetrical waveform will be used.
The 100 Hz current will be applied for 10 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 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Timed up and go test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Grip Strength
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sevim A CANDAN, T.C. ORDU ÜNİVERSİTESİ
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de febrero de 2018
Finalización primaria (Actual)
16 de marzo de 2018
Finalización del estudio (Actual)
21 de marzo de 2018
Fechas de registro del estudio
Enviado por primera vez
17 de enero de 2018
Primero enviado que cumplió con los criterios de control de calidad
23 de enero de 2018
Publicado por primera vez (Actual)
24 de enero de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
21 de marzo de 2018
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AR-1665
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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