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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

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

      • Oslo, Noruega, 0863
        • Norwegian School of Sport Sciences

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

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
Experimental: Strength training + protein supplement
Heavy-load strength training, Protein supplementation
Three weekly sessions of heavy-load strength training for 10 weeks
Otros nombres:
  • Ejercicio de resistencia
Daily supplementation of 2 x 17 grams of milk protein

¿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)
Change from baseline at 10 weks
Muscle strength of m. quadriceps femoris
Periodo de tiempo: Change from baseline at 10 weeks
Maximal dynamic muscle strength of m. quadriceps femoris (knee extension 1 repetition maximum)
Change from baseline at 10 weeks
Leg lean mass
Periodo de tiempo: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks

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
Medido por ultrasonido
Cambio desde el inicio a las 10 semanas
Total lean mass
Periodo de tiempo: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
Fat mass
Periodo de tiempo: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
Bone mineral density
Periodo de tiempo: Change from baseline at 10 weeks
Measured by Dual-energy X-ray Absorptiometry (DXA-scan)
Change from baseline at 10 weeks
m. Rectus Femoris thickness
Periodo de tiempo: Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
m. Vastus Intermedius thickness
Periodo de tiempo: Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
m. Vastus Medialis thickness
Periodo de tiempo: Change from baseline at 10 weeks
Measured by ultrasound
Change from baseline at 10 weeks
Isometric knee extension rate of force development (RFD max)
Periodo de tiempo: Change from baseline at 10 weeks
Measured during maximal voluntary contraction
Change from baseline at 10 weeks
Isometric knee extension force at 100 ms
Periodo de tiempo: Change from baseline at 10 weeks
Force at 100 ms during maximal voluntary contraction
Change from baseline at 10 weeks
Habitual gait velocity
Periodo de tiempo: Change from baseline at 10 weeks
Time (sec) to walk 6 meters at preferred gait speed
Change from baseline at 10 weeks
Five times chair-rise performance
Periodo de tiempo: Change from baseline at 10 weeks
Time (sec) to rise from a chair five times
Change from baseline at 10 weeks
Stair climbing
Periodo de tiempo: Change from baseline at 10 weeks
Time (sec) to climb a staircase
Change from baseline at 10 weeks
Diet assessment
Periodo de tiempo: Change from baseline at 10 weeks
24-hour diet recall interviews
Change from baseline at 10 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

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

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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