- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05777941
Entrenamiento de la Fuerza con Giro Excéntrico de Brazos en Para-atletas (KREHA-ParAth)
The new training device, the eccentric arm-crank, will be examined for its training effects in athletes with a spinal cord injury (SCI) by this project. That the training device can be used in patients with paraplegia in the future, the so-called "testing of the applicability of this concept" will be carried out during this study. Fourteen volunteer, healthy athletes with SCI are first tested for their upper body performance, followed by a training phase over 20 trainings and at the end the performance data is collected again. The training intensity and duration is continuously increased during the training phase.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
At the beginning, the study design includes a familiarisation appointment with performance tests and training on the eccentric arm-crank device (KREHA). At least one week later, the first test sequence including a maximum strength test (bench press) and a test to determine the anaerobic performance (Wingate test) is conducted. The second test sequence takes place one to three days later. This includes a handgrip strength test, an aerobic endurance test (ramp test on the arm crank ergometer with ergospirometry) and a further familiarisation training on the KREHA. The training phase starts within two weeks after the pre-tests have been completed. There are two to a maximum of three trainings per week. These take 30 to 45 minutes and take place on the KREHA device under the supervision of the study staff. The training phase lasts a maximum of twelve weeks (20 training sessions). The first test sequence is repeated five to eight days after the last workout. The second test sequence takes place at the same time interval as in the pre-tests.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Canton of Lucerne
-
Nottwil, Canton of Lucerne, Suiza, 6207
- Swiss Paraplegic Centre
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- male or female with traumatic or disease-related SCI
- age between 18 and 50 years
- experience in strength training
- Squad status or at least 4h per week training
- Biceps/triceps function
- healthy(study physician)
- adequately informed and confirmed per signature
Exclusion Criteria:
- findings during anamnesis of study physician
- pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Eccentric Training
This Group will train on the KREHA for 20 Trainings |
Over the twenty training sessions, able-bodied participants will exercise on the KREHA device. An arm-crank has to be decelerated, which will be rotated by a prematurely defined revolution rate and training duration. During this intervention a certain power has to be applied. During the whole time of training a continous progression in power and training duration is applied. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Upper body Performance
Periodo de tiempo: through study completion, an average of 20 weeks
|
Peak Power - maximal reached power, generated during the 30sec Wingate arm-crank test |
through study completion, an average of 20 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Endurance Oxygen consumption
Periodo de tiempo: through study completion, an average of 20 weeks
|
VO2peak [ml/min/kg] - Basic Endurance test (Ergospirometry, arm-crank) |
through study completion, an average of 20 weeks
|
|
Maximal Workload
Periodo de tiempo: through study completion, an average of 20 weeks
|
Wmax [W] - Basic Endurance test (Ergospirometry, arm-crank) |
through study completion, an average of 20 weeks
|
|
Upper body Mean Power
Periodo de tiempo: through study completion, an average of 20 weeks
|
Mean Power [W] - Wingate Test (arm-crank) |
through study completion, an average of 20 weeks
|
|
Upper body Power - Time to Peak
Periodo de tiempo: through study completion, an average of 20 weeks
|
Time to Peak [s] - Wingate Test (arm-crank) |
through study completion, an average of 20 weeks
|
|
Upper body Fatigue Index
Periodo de tiempo: through study completion, an average of 20 weeks
|
Fatigue Index [%]- Wingate Test (arm-crank) |
through study completion, an average of 20 weeks
|
|
Upper body Fatigue Slope
Periodo de tiempo: through study completion, an average of 20 weeks
|
Fatigue Slope [W/s] - Wingate Test (arm-crank) |
through study completion, an average of 20 weeks
|
|
1RM bench press
Periodo de tiempo: through study completion, an average of 20 weeks
|
One Repetition Maximum (1RM) [kg]- bench press |
through study completion, an average of 20 weeks
|
|
Grip Strength
Periodo de tiempo: through study completion, an average of 20 weeks
|
Maximal Force that can be generated by pressing hand towards a fist [N] |
through study completion, an average of 20 weeks
|
|
Upper Arm Circumference
Periodo de tiempo: through study completion, an average of 20 weeks
|
Circumference of the upper arm is measured with measuring tape |
through study completion, an average of 20 weeks
|
|
Lower Arm Circumference
Periodo de tiempo: through study completion, an average of 20 weeks
|
Circumference of the lower arm is measured with measuring tape |
through study completion, an average of 20 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Fabian Ammann, MSc, SPZ
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- 2022-06
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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