- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07646405
Combined Effects of NMES and LIRT on Muscle Strength, Girth, and Physical Endurance in the Geriatric Population
Combined Effects of Neuromuscular Electrical Stimulation and Low-intensity Resistance Training on Muscle Strength, Girth, and Physical Endurance in Geriatric Population
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Informed Consent: Obtain informed consent from participants before starting the study.
2. Demographic Data Collection: Collect demographic data, including age, sex, height, weight, and medical history.
3. Muscle Strength Assessment: Measure muscle strength using a dynamometer (e.g., handgrip strength or knee extension strength).
4. Muscle Girth Measurement: Measure muscle girth using a flexible measuring tape (e.g., mid-upper arm or thigh circumference).
5. 6-Minute Walk Test (6MWT): Conduct the 6MWT to assess physical endurance. Intervention
- NMES Sessions: Administer NMES sessions 2-3 times a week for 4-5 weeks.
- LIRT Sessions: Conduct LIRT exercises 2-3 times a week for 4-5weeks, targeting major muscle groups of upper and lower limb.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Isha butt butt, DPT
- Número de teléfono: 03324390215
- Correo electrónico: ishamb.09876@gmail.com
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Reclutamiento
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:• Age: 65 to 85 (35)
- Both male and female will be added(29)
- Patients with low calf muscle mass <31.5 cm for females and <33.5 cm for males will be included in this study(36).
- Participants able to complete the Five Times Sit-to-Stand Test in ≤ 10 seconds (men) or ≤ 11 seconds (women)(37).
- Participants must have ability to walk independently and absence of severe medical conditions(29).
- Participants who takes > 12 seconds to complete TUG will be included in this study(38
Exclusion Criteria:• Participants with contraindications to NMES or RT, such as pacemakers or severe cardiovascular disease(29).
- Participants with a MoCA score of less than 26 will be excluded to ensure adequate cognitive ability to comprehend and follow the study protocol, including exercise and neuromuscular stimulation procedures (39).
- Participants with any musculoskeletal issues will be excluded from this study(35).
- Participants with neuromuscular disorders that may affect muscle strength or function(29).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Neuromuscular electrical stimulation
Prior to the initiation of resistance training, participants will receive 20 minutes of NMES targeting the gastrocnemius and calf muscles Frequency: 35 Hz Pulse duration: 300 µs Following NMES, participants will undergo a 20-minute LIRT session comprising the following exercises: |
Prior to the initiation of resistance training, participants will receive 20 minutes of NMES targeting the gastrocnemius and calf muscles Frequency: 35 Hz Pulse duration: 300 µs Following NMES, participants will undergo a 20-minute LIRT session comprising the following exercises: |
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Comparador activo: conventinal
5minutes cool-down will be given after allocated interventions to participants of both groups.
Gentle foot massage and stretching relaxation will be included in cool-down.
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Seated Leg Press with Thera Band Resistance (Sole Support Position) Participants will be seated with a Thera Band looped around the soles of their feet and held in the hands to provide resistance during leg extension. Repetitions: 10 Sets: 3 Rest Interval: 30-60 seconds between sets |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Manual muscle testing (MMT) for strength measurement
Periodo de tiempo: baseline to 4 week
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Muscle strength will be assessed using Manual Muscle Testing (MMT) of the plantar flexors and knee extensors based on the Medical Research Council (MRC) 0-5 grading scale.
Each muscle group will be tested twice on the dominant side, and the higher grade will be recorded.
Participants with grades ≤3 will be classified as having low muscle strength, while those with grades ≥4 will be considered to have sufficient strength for participation in low-intensity resistance training and neuromuscular electrical stimulation (NMES).
MMT is a reliable and widely used clinical method for muscle strength assessment
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baseline to 4 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sabiha Arshad, MS, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC/RCR&AHS/25/0217
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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