La respuesta cardiorrespiratoria aguda a los regímenes de entrenamiento de ejercicio con flujo sanguíneo restringido versus tradicional (CaRe BFR) (CaRe-BFR)
La respuesta cardiorrespiratoria aguda a los regímenes de entrenamiento con ejercicios con flujo sanguíneo restringido versus los tradicionales (CaRe BFR): 4 estudios cruzados aleatorizados
Los investigadores plantean la hipótesis de que los regímenes de ejercicio BFR dan como resultado un patrón de respuesta cardiorrespiratoria aguda diferente en comparación con los regímenes de ejercicio tradicionales. Además, los investigadores plantean la hipótesis de que estos patrones difieren entre participantes sanos y participantes con EPOC.
Con respecto al objetivo secundario, los investigadores plantean la hipótesis de que la BFR produce respuestas de presión arterial más bajas en comparación con el entrenamiento físico tradicional tanto en participantes sanos como con EPOC.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Los investigadores llevan a cabo un proyecto monocéntrico con 4 estudios aleatorios cruzados.
CaRe-BFR Saludable y EPOC:
El entrenamiento de fuerza se realiza de forma bilateral en una máquina Leg Press (Leg Press VR2, Cybex International Inc. Medway, MA, EE. UU.) utilizando la metodología de tres series, que ha demostrado ser la más eficaz para mejorar la fuerza muscular.16 Cada serie se realiza hasta el fallo muscular, que debe alcanzarse en 8-12 repeticiones. El ritmo de entrenamiento se establece en 1-0-1-0 (es decir, un segundo para la fase concéntrica, sin pausa, un segundo para la fase excéntrica, sin pausa) y un metrónomo lo controla externamente. La carga de entrenamiento es el 80% del 1RM. El descanso entre series es de 1 minuto y los participantes permanecen
El entrenamiento de fuerza BFR se realiza bilateralmente en una máquina Leg Press (Leg Press VR2, Cybex International Inc. Medway, MA, EE. UU.) de acuerdo con las pautas de aplicación basadas en evidencia para aplicar la metodología más efectiva para mejorar la fuerza muscular.17 El ejercicio consta de un total de 75 repeticiones durante 4 series. El ritmo de entrenamiento se establece en 1-0-1-0 (es decir, un segundo para la fase concéntrica, sin pausa, un segundo para la fase excéntrica, sin pausa) y un metrónomo lo controla externamente. El juego 1 cubre 30 repeticiones y los juegos subsiguientes 15 repeticiones cada uno. La carga de entrenamiento es el 30% del 1RM. Los manguitos se montan bilateralmente en la parte más proximal del muslo y se inflan al 70 % del AOP individual. El descanso entre series es de 1 minuto y los participantes permanecen sentados con los puños inflados.
-La resistencia se realiza bilateralmente en una bicicleta ergométrica estacionaria (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Alemania) en una configuración de intervalos con fases de carga de 1 serie con 3 intervalos de 2 minutos cada uno; la carga de entrenamiento es el 65% de la tasa de trabajo pico (PWR). Entre los intervalos, los descansos están estandarizados a 1 minuto. Antes de la sesión de ejercicio, se realiza un calentamiento en bicicleta al 30 % de PWR durante 5 minutos para alcanzar un estado estable en HR y RER.
El BFR de resistencia se realiza bilateralmente en una bicicleta ergométrica estacionaria (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Alemania) en una configuración de intervalos con fases de carga de 1 serie con 3 intervalos de 2 minutos y 18 segundos cada uno (que coincide con el trabajo general realizado en ES); la carga de entrenamiento es del 50 % del PWR, mientras que el flujo sanguíneo de las extremidades está restringido al 50 % del AOP. Entre los intervalos, los descansos están estandarizados a 1 minuto (manguito inflado). Antes de la sesión de ejercicio, se realiza un calentamiento en bicicleta (sin BFR) al 30 % de PWR durante 5 minutos para alcanzar un estado estable en HR y RER.
Mediciones:
Durante el ejercicio, los investigadores recopilan datos respiración a respiración (Ergostik, Geratherm Respiratory GmbH, Bad Kissingen, Alemania). Además, se recopilan datos continuos de SpO2 y FC a través de una sonda en el lóbulo de la oreja, y la respuesta de la PA inmediatamente después de las series de ejercicio.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Christan Clarenbach, Dr. med
- Número de teléfono: 044 255 22 21
- Correo electrónico: Christian.clarenbach@usz.ch
Copia de seguridad de contactos de estudio
- Nombre: Manuel Kuhn, PhD Student
- Número de teléfono: 0798526722
- Correo electrónico: manuel.kuhn@usz.ch
Ubicaciones de estudio
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Canton of Zurich
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Zurich, Canton of Zurich, Suiza, 8091
- Reclutamiento
- University Hospital Zurich
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Contacto:
- Manuel Kuhn, MSc
- Número de teléfono: 0432532681
- Correo electrónico: manuel.kuhn@usz.ch
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Contacto:
- Alexandra Arvaji
- Número de teléfono: 0432530131
- Correo electrónico: alexandra.arvaji@usz.ch
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
La inclusión y la exclusión de los participantes sanos se definen por los siguientes criterios.
Criterios de inclusión:
- Edad ≥ 18 años
- Clínicamente saludable
Criterio de exclusión:
- Deterioro físico o intelectual que impide el consentimiento informado o la adherencia al protocolo
- Habla no alemana (excluyendo el consentimiento informado)
- Dolor durante el ejercicio de cualquier origen.
- El embarazo
- Historia de evento tromboembólico en la extremidad inferior
- Presión arterial sistólica en reposo <100 mmHg
La inclusión y la exclusión de los participantes con EPOC se definen según los siguientes criterios.
Criterios de inclusión:
- Edad ≥ 18 años
- EPOC diagnosticada según las guías GOLD12
Criterio de exclusión:
- Deterioro físico o intelectual que impide el consentimiento informado o la adherencia al protocolo
- Habla no alemana (excluyendo el consentimiento informado)
- Exacerbación aguda o reciente (dentro de las últimas 6 semanas) de EPOC
- Dolor durante el ejercicio de cualquier origen.
- El embarazo
- Historia de evento tromboembólico en la extremidad inferior
- Presión arterial sistólica en reposo <100 mmHg
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Endurance Exercise - COPD and Healthy Participants (Fixed-Duration Protocol)
Both COPD patients and healthy participants will complete two endurance exercise conditions in a randomized, crossover design:
BFR-CYC: Three intervals of 2 minutes at 50% PWR, separated by 1-minute recovery periods, with bilateral thigh cuffs inflated to 50% LOP during exercise intervals. Control: Time- and structure-matched protocol (3 × 2 minutes) without blood flow restriction at 65% PWR, with identical recovery periods. |
BFR-CYC: Three intervals of 2 minutes at 50% PWR, separated by 1-minute recovery periods, with bilateral thigh cuffs inflated to 50% LOP during exercise intervals.
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Experimental: Resistance Exercise - COPD and Healthy Participants (BFR vs Control, Fixed Protocol)
Both COPD patients and healthy participants will complete two resistance exercise conditions in a randomized, crossover design:
Control: Bilateral leg press at 40% 1RM, 3 sets of 15 repetitions, without blood flow restriction. |
BFR-RE: Unilateral right-leg press at 40% of one-repetition maximum (1RM) with cuffs inflated to 80% LOP.
Protocol: 4 sets (30-15-15-15 repetitions).
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Experimental: Endurance Exercise - COPD Participants (Exhaustive Protocol)
Patients with COPD will complete three cycling exercise conditions in a randomized, crossover design:
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BFR-CYC: Continuous cycling at 50% peak work rate (PWR) with bilateral thigh cuffs inflated to 50% limb occlusion pressure (LOP).
A maximum duration of 30 minutes is applied as a safety limit.
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Experimental: Resistance Exercise - Healthy Participants (LOP Comparison Arm)
Healthy participants will complete two BFR resistance exercise conditions in a randomized, crossover design:
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Participants will perform unilateral right-leg press exercise at 40% 1RM using a standardized protocol of 4 sets (30-15-15-15 repetitions) with fixed rest intervals. The protocol will be completed as prescribed (not to volitional exhaustion) unless predefined safety criteria require early termination. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Endurance Exercise:(Fixed-Duration Protocol):
Periodo de tiempo: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand.
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Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Resistance Exercise - Healthy Participants (LOP Comparison Arm): Within-subject difference change in Maximal Voluntary Contraction (MVC)
Periodo de tiempo: Pre-exercise and immediately post-exercise (within minutes after completion of the exercise protocol)
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Maximal voluntary contraction (MVC) of the knee extensors will be assessed before and immediately after unilateral leg press exercise performed with blood flow restriction at 40% and 80% limb occlusion pressure (LOP).
MVC will be measured using an isometric setup, and voluntary activation will be evaluated using the twitch interpolation technique with supramaximal electrical stimulation.
The primary outcome is the change in MVC from pre- to post-exercise, reflecting exercise-induced neuromuscular fatigue.
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Pre-exercise and immediately post-exercise (within minutes after completion of the exercise protocol)
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Endurance Exercise - COPD Participants (Exhaustive Protocol): Within-subject difference in maximal minute ventilation (VE) between BFR and traditional exercise regimens
Periodo de tiempo: Continuously during exercise, at end of exercise (peak value), and within 4 minutes post-exercise
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Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand and response.
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Continuously during exercise, at end of exercise (peak value), and within 4 minutes post-exercise
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Resistance Exercise:(Healthy and COPD): Ventilatory Response (Ventilation, VE)
Periodo de tiempo: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand.
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Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Resistance Exercise - Healthy Participants (LOP Comparison Arm): Muscle Oxygenation (NIRS)
Periodo de tiempo: Continuously during exercise and immediately post-exercise
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Muscle oxygenation of the knee extensors will be continuously assessed using near-infrared spectroscopy (NIRS) during unilateral leg press exercise performed with blood flow restriction at 40% and 80% limb occlusion pressure (LOP).
Parameters such as tissue oxygen saturation will be analyzed to evaluate local muscular oxygenation responses.
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Continuously during exercise and immediately post-exercise
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Resistance Exercise - Healthy Participants (LOP Comparison Arm): Perceived Exertion / Dyspnea (Borg Scale)
Periodo de tiempo: At baseline (pre-exercise), after each set, immediately post-exercise, and at 2 and 4 minutes post-exercise
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Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise. Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise. |
At baseline (pre-exercise), after each set, immediately post-exercise, and at 2 and 4 minutes post-exercise
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Endurance Exercise - COPD Participants (Exhaustive Protocol): Cardiorespiratory Response (Vo2 , VCO2)
Periodo de tiempo: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Oxygen uptake (VO₂) will be continuously measured during cycling exercise performed under three conditions (BFR-CYC, CONT-CYC, INT-CYC) to symptom limitation. The primary outcome will be the peak VO₂ achieved at end of exercise, reflecting maximal cardiorespiratory response. Carbon dioxide production (VCO₂) will be continuously measured during exercise to assess metabolic and ventilatory responses. |
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Endurance Exercise - COPD Participants (Exhaustive Protocol):NIRS
Periodo de tiempo: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Muscle oxygenation will be assessed using near-infrared spectroscopy (NIRS) during cycling exercise to evaluate local muscular oxygenation under BFR and non-BFR conditions.
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Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
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Endurance Exercise - COPD Participants (Exhaustive Protocol): Blood Lactate Concentration
Periodo de tiempo: At baseline (pre-exercise) at peak and 3 min wpost-exercise
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Capillary blood lactate concentration will be measured to assess metabolic stress induced by the different exercise conditions.
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At baseline (pre-exercise) at peak and 3 min wpost-exercise
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Endurance Exercise - COPD Participants (Exhaustive Protocol): Perceived Exertion and Dyspnea (Borg Scale)
Periodo de tiempo: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
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Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise. Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise. |
At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
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Endurance Exercise - COPD Participants (Exhaustive Protocol): Exercise Tolerance (Time to Exhaustion)
Periodo de tiempo: During exercise (recorded at end of exercise)
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Exercise tolerance will be defined as the time from the start of exercise to symptom limitation (volitional exhaustion).
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During exercise (recorded at end of exercise)
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Endurance Exercise:(Fixed-Duration Protocol): Cardiorespiratory Response (Vo2 , VCO2)
Periodo de tiempo: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
|
Carbon dioxide production (VCO₂) will be continuously measured during exercise to assess metabolic and ventilatory responses Oxygen uptake (VO₂) will be continuously measured during cycling exercise performed under two conditions.
The primary outcome will be the peak VO₂ achieved at end of exercise, reflecting maximal cardiorespiratory response.
|
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
|
|
Endurance Exercise:(Fixed-Duration Protocol): Borg Scale (Dyspnea/Perceived Exertion)
Periodo de tiempo: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
|
Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise. Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise. |
At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
|
|
Resistance Exercise:(Healthy and COPD): Cardiorespiratory Response
Periodo de tiempo: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
|
Oxygen uptake (VO₂) will be continuously measured during cycling exercise performed under two conditions. Carbon dioxide production (VCO₂) will be continuously measured during exercise to assess metabolic and ventilatory responses. |
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
|
|
Resistance Exercise:(Healthy and COPD): Dyspnea (Borg Scale/ Perceived Exertion )
Periodo de tiempo: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
|
Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise. Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise. |
At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christian Clarenbach, Dr. med, University of Zurich
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2021-02038
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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