- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02658266
Effect of Resistance Training in Adults With Complex Congenital Heart Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The number of adults with complex congenital heart disease is increasing and today they outnumber the children with corresponding lesions. However, the longterm prognosis is still unknown and continuously changing as new therapeutic options are introduced.
Patients with complex congenital heart disease have reduced muscle function compared to healthy controls as well as patients with lesions classified as simple. Furthermore, men with congenital heart disease are more commonly underweight and less commonly overweight obese compared to the general population. In addition, men with complex lesions are shorter in comparison to controls. This indicates an altered body composition i.e. muscle mass, fat mass and bone density in this population. Moreover, impaired muscle metabolism has been reported in patients palliated with Fontan procedure.
Adult patients with complex congenital heart disease will be recruited based on defined inclusion and exclusion criteria. Muscle function, muscle strength, muscle metabolism and body composition will be evaluated before randomisation and at follow-up after twelve weeks. The patients will be randomised to twelve weeks of home based resistance training or to a control group. The randomisation ratio will be 1:1 ( intervention:control). The control group will be instructed to continue with their habitual physical activities. The resistance training protocol will be individualised based on the results of the muscle function and muscle strength tests.
The aim of this study is to investigate the effects of resistance training on muscle function, muscle strength, body composition and muscle metabolism in adults with complex congenital heart disease.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bengt Johansson, MD, PhD
- Número de teléfono: +46907852782
- Correo electrónico: bengt.johansson@medicin.umu.se
Copia de seguridad de contactos de estudio
- Nombre: Camilla Sandberg, PhD stud
- Número de teléfono: +46907858441
- Correo electrónico: camilla.sandberg@medicin.umu.se
Ubicaciones de estudio
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Lund, Suecia, 22185
- Terminado
- Skåne University Hospital
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Umeå, Suecia, 90185
- Reclutamiento
- University Hospital
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Contacto:
- Bengt Johansson, MD, PhD
- Número de teléfono: +46907852782
- Correo electrónico: bengt.johansson@medicin.umu.se
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Contacto:
- Camilla Sandberg, RPT, PhD
- Número de teléfono: +46907858441
- Correo electrónico: camilla.sandberg@medicin.umu.se
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Investigador principal:
- Bengt Johansson, MD, PhD
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Sub-Investigador:
- Camilla Sandberg Sandberg, RPT, PhD
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Uppsala, Suecia
- Reclutamiento
- University Hospital Uppsala
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Contacto:
- Christina Christersson, MD, Phd
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Complex congenital heart disease ( e.g. tetralogy of Fallot, transposition of the great arteries, pulmonary atresia, patients palliated with Fontan procedure or total cavo-pulmonary connection).
- Clinically stable without significant change the last 3 months.
- Adult (> 18 years of age).
- Informed consent.
Exclusion Criteria:
- Cognitive impairment affecting the ability of independent decision making.
- Present strategy of regularly executing resistance training > 2times per week in purpose to increase muscle strength.
- Other comorbidity affecting physical activity.
- Other circumstance making participation unsuitable.
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 |
---|---|
Experimental: Resistance training
Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets
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The participants in the intervention group will receive an individualized resistance training program.
The individual adjustments in load will will be made from the results of the muscle function and muscle strength tests.
The resistance training will be home based and performed 3 times per week 10-12 reps 2 sets 12 weeks.
Increment of load will be performed continuously according to rating of perceived exertion.
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Sin intervención: Control group
No instructed exercise training.
Continue with habitual physical activity.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in muscle strength (Newton, N)
Periodo de tiempo: Change from baseline muscle strength at 12 weeks follow-up
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Change from baseline muscle strength at 12 weeks follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in muscle endurance (number of repetitions)
Periodo de tiempo: Change from baseline muscle endurance at 12 weeks follow-up
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Change from baseline muscle endurance at 12 weeks follow-up
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Change in total body skeletal muscle mass (kg)
Periodo de tiempo: Change from baseline total body skeletal muscle mass at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline total body skeletal muscle mass at 12 weeks follow-up
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Change in appendicular skeletal muscle mass (kg)
Periodo de tiempo: Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
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Change in body fat percentage
Periodo de tiempo: Change from baseline body fat percentage at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline body fat percentage at 12 weeks follow-up
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Change in bone mineral density (g/cm2)
Periodo de tiempo: Change from baseline bone mineral density at 12 weeks follow-up
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Using dual-energy x-ray absorptiometry (DEXA)
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Change from baseline bone mineral density at 12 weeks follow-up
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Muscle metabolism
Periodo de tiempo: Change from baseline muscle metabolism at 12 weeks follow-up
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near infrared spectroscopy (NIRS)
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Change from baseline muscle metabolism at 12 weeks follow-up
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Compliance to study protocol
Periodo de tiempo: At completion of study protocol 12 weeks
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number of training sessions
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At completion of study protocol 12 weeks
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Adverse events
Periodo de tiempo: Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
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Complications to resistance training
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Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bengt Johansson, MD, Phd, Umea University
Publicaciones y enlaces útiles
Publicaciones Generales
- Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.
- Cordina R, O'Meagher S, Gould H, Rae C, Kemp G, Pasco JA, Celermajer DS, Singh N. Skeletal muscle abnormalities and exercise capacity in adults with a Fontan circulation. Heart. 2013 Oct;99(20):1530-4. doi: 10.1136/heartjnl-2013-304249. Epub 2013 Jul 11. Erratum In: Heart. 2013 Dec;99(23):1788. Singh, Nalin [added].
- Sandberg C, Thilen U, Wadell K, Johansson B. Adults with complex congenital heart disease have impaired skeletal muscle function and reduced confidence in performing exercise training. Eur J Prev Cardiol. 2015 Dec;22(12):1523-30. doi: 10.1177/2047487314543076. Epub 2014 Jul 18.
- Kroonstrom LA, Johansson L, Zetterstrom AK, Dellborg M, Eriksson P, Cider A. Muscle function in adults with congenital heart disease. Int J Cardiol. 2014 Jan 1;170(3):358-63. doi: 10.1016/j.ijcard.2013.11.014. Epub 2013 Nov 13.
- Sandberg C, Rinnstrom D, Dellborg M, Thilen U, Sorensson P, Nielsen NE, Christersson C, Wadell K, Johansson B. Height, weight and body mass index in adults with congenital heart disease. Int J Cardiol. 2015;187:219-26. doi: 10.1016/j.ijcard.2015.03.153. Epub 2015 Mar 18.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- GUCHUmU02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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