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- Ensayo clínico NCT03723902
The Effect of Strength Training and Protein Supplementation in Old Pre-frail Individuals
12 de marzo de 2019 actualizado por: Truls Raastad, Norwegian School of Sport Sciences
Strength Training and Protein Supplementation in Pre-frail Elderly Individuals. Effects on Muscle Mass, Muscle Strength, Rate of Force Development and Functional Capacity
The aim of this study is to investigate the effects of a lower-body strength training regime combined with protein supplementation in pre-frail elderly individuals.
Participants are randomized to a group performing three weekly sessions of heavy-load strength training for 10 weeks and receiving daily protein supplementation, or a non-training, non-supplemented control group.
The endpoints are changes in body composition, the relative changes in different compartments of the quadriceps femoris muscles, and the relationships between changes in muscle mass, muscle thickness, strength, and functional capacity.
The investigators hypothesize that 10 weeks of heavy load strength training and protein supplementation will elicit improvements in muscle mass, strength, and functional performance.
Moreover, it is hypothesized that improvements in strength will correlate with the improvements in functional performance.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Aging is accompanied by a loss of muscle mass and strength.
Because muscle strength is associated with functional performance in elderly individuals, various tasks of daily living is hampered by the overall decline.
The consequence is a vicious circle, where inactivity caused by reduced functional capacity accelerates the loss of muscle mass, strength and physical function.
The Short Physical Performance Battery (SPPB) is commonly used to assess functional capacity, where individuals with a score of 10 or less out of maximum 12 may be categorized as pre-frail.
Because small-to-moderate limitations in functional status assessed by SPPB is associated with higher odds of losing future mobility, these individuals represent a group of great interest.
Strategies to improve functional capacity in this population are therefore important.
It is established that heavy-load strength training, alone or in combination with protein supplementation, can improve muscle mass, strength, and function in elderly individuals.
However, most studies have focused on healthy older adults, and less is known about the effects of heavy-load strength training in pre-frail elderly individuals.
Moreover, the extent to which training-induced gains in muscle mass and size are related to improvements in strength and functional capacity is still poorly understood, because few intervention studies in this population have quantified hypertrophy precisely.
Hence, the aim of this study is to investigate the effects of 10 weeks of heavy load strength training, performed three times per week, on muscle mass (DXA scan), muscle thickness (ultrasound), muscle strength (dynamic and isometric), rate of force development, chair rise ability, and gait velocity.
Participants are randomized to a group performing three weekly sessions of heavy-load strength training or a control group.
In addition, to optimize gains in muscle mass and strength, the strength training group will receive daily protein supplementation throughout the intervention period.
The investigators hypothesize that the intervention will improve muscle mass, muscle thickness and strength, and that improvements in muscle strength and rate of force development will be correlated with improvements in functional capacity.
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
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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-
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Oslo, Noruega, 0863
- Norwegian School of Sport Sciences
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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
75 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age > 75
- Short Physical Performance Battery (SPPB) score ≤ 10
Exclusion Criteria:
- Lactose intolerance
- Milk allergy
- Diseases or musculoskeletal disorders contraindicating training/testing
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Control
Sin intervención
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Experimental: Strength training + protein supplement
Heavy-load strength training, Protein supplementation
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Three weekly sessions of heavy-load strength training for 10 weeks
Otros nombres:
Daily supplementation of 2 x 17 grams of milk protein
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Muscle strength of m. Quadriceps Femoris
Periodo de tiempo: Change from baseline at 10 weks
|
Maximal isometric muscle strength of m. quadriceps femoris (maximal voluntary contraction for the knee extensors)
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Change from baseline at 10 weks
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Muscle strength of m. quadriceps femoris
Periodo de tiempo: Change from baseline at 10 weeks
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Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)
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Change from baseline at 10 weeks
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Leg lean mass
Periodo de tiempo: Change from baseline at 10 weeks
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Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
metro. Grosor del vasto lateral
Periodo de tiempo: Cambio desde el inicio a las 10 semanas
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Medido por ultrasonido
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Cambio desde el inicio a las 10 semanas
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Total lean mass
Periodo de tiempo: Change from baseline at 10 weeks
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Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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Fat mass
Periodo de tiempo: Change from baseline at 10 weeks
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Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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Bone mineral density
Periodo de tiempo: Change from baseline at 10 weeks
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Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
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Change from baseline at 10 weeks
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m. Rectus Femoris thickness
Periodo de tiempo: Change from baseline at 10 weeks
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Measured by ultrasound
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Change from baseline at 10 weeks
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m. Vastus Intermedius thickness
Periodo de tiempo: Change from baseline at 10 weeks
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Measured by ultrasound
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Change from baseline at 10 weeks
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m. Vastus Medialis thickness
Periodo de tiempo: Change from baseline at 10 weeks
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Measured by ultrasound
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Change from baseline at 10 weeks
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Isometric knee extension rate of force development (RFD max)
Periodo de tiempo: Change from baseline at 10 weeks
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Measured during maximal voluntary contraction
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Change from baseline at 10 weeks
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Isometric knee extension force at 100 ms
Periodo de tiempo: Change from baseline at 10 weeks
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Force at 100 ms during maximal voluntary contraction
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Change from baseline at 10 weeks
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Habitual gait velocity
Periodo de tiempo: Change from baseline at 10 weeks
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Time (sec) to walk 6 meters at preferred gait speed
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Change from baseline at 10 weeks
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Five times chair-rise performance
Periodo de tiempo: Change from baseline at 10 weeks
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Time (sec) to rise from a chair five times
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Change from baseline at 10 weeks
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Stair climbing
Periodo de tiempo: Change from baseline at 10 weeks
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Time (sec) to climb a staircase
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Change from baseline at 10 weeks
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Diet assessment
Periodo de tiempo: Change from baseline at 10 weeks
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24-hour diet recall interviews
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Change from baseline at 10 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
1 de julio de 2015
Finalización primaria (Actual)
21 de diciembre de 2015
Finalización del estudio (Actual)
21 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
26 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
29 de octubre de 2018
Publicado por primera vez (Actual)
30 de octubre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de marzo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
12 de marzo de 2019
Última verificación
1 de marzo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- ST-PF
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
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