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Contralateral Resistance Training During Immobilization in Patients With Acromioclavicular Joint Injury (CROSS-ACD)

4 de junio de 2026 actualizado por: Omar Esteban Valdés Tapia, Universidad Nacional Andres Bello

Effects of Contralateral Eccentric and Concentric Resistance Training During Immobilization on Neuromuscular Function, Functional Recovery, and Quality of Life in Patients With Acromioclavicular Joint Injury: A Randomized Controlled Trial

This randomized controlled trial aims to compare the effects of contralateral eccentric and concentric resistance training performed during the immobilization period following acromioclavicular joint injury. Immobilization is commonly prescribed after injury but may lead to reductions in muscle mass, neuromuscular function, force production, and upper-limb functionality.

Contralateral resistance training, also known as cross-education training, involves exercising the non-injured limb to induce beneficial adaptations in the immobilized limb through neural mechanisms. While both eccentric and concentric exercise may produce contralateral effects, their relative effectiveness in a clinical population remains unclear.

Participants with acute acromioclavicular joint injury requiring sling immobilization will be randomly assigned to either a contralateral eccentric training group or a contralateral concentric training group. During immobilization, participants will perform supervised resistance training with the non-injured upper limb. Following immobilization, all participants will receive the same standardized rehabilitation program.

Neuromuscular function, muscle morphology, force production, upper-limb function, and quality of life will be assessed before immobilization, after immobilization, and following rehabilitation. The findings may contribute to the development of more effective rehabilitation strategies for patients recovering from upper-limb injuries requiring temporary immobilization.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Acromioclavicular joint injury is one of the most common shoulder injuries in physically active individuals. Temporary immobilization using a sling is frequently prescribed during the acute phase of recovery; however, immobilization can result in rapid declines in muscle strength, muscle mass, neuromuscular function, and upper-limb performance.

Cross-education is a neurophysiological phenomenon whereby unilateral resistance training induces adaptations in the contralateral untrained limb. Previous experimental studies have demonstrated that resistance exercise performed with the non-immobilized limb may attenuate strength loss and neuromuscular impairments in an immobilized limb. However, the relative effectiveness of different muscle contraction modes during cross-education training in clinical populations remains poorly understood.

The purpose of this randomized controlled trial is to compare the effectiveness of contralateral eccentric versus contralateral concentric resistance training performed during the immobilization period in patients with acromioclavicular joint injury. Participants will be randomly allocated to one of two intervention groups: (1) contralateral eccentric resistance training or (2) contralateral concentric resistance training. Both interventions will be performed using the non-injured upper limb during the period of prescribed sling immobilization.

Participants will undergo comprehensive assessments before immobilization, immediately after immobilization, and after completion of a standardized rehabilitation program. Outcomes will include measures of neuromuscular function obtained through peripheral nerve stimulation, transcranial magnetic stimulation, electromyography, and voluntary force assessments. Muscle morphology will be evaluated using ultrasound imaging, while upper-limb function and quality of life will be assessed using validated clinical questionnaires.

Following immobilization, all participants will receive the same rehabilitation program focused on restoring shoulder stability, muscle strength, and functional capacity. The primary objective is to determine whether eccentric or concentric contralateral resistance training more effectively preserves neuromuscular function and facilitates recovery following immobilization.

The results of this study may provide evidence to optimize rehabilitation strategies for patients with acromioclavicular joint injuries and other musculoskeletal conditions requiring temporary upper-limb immobilization.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

16

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.

Estudio Contacto

Ubicaciones de estudio

  • Chile
    • Providencia
      • Santiago, Providencia, Chile
        • Reclutamiento
        • Clínica Indisa
        • Contacto:

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

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Men and women aged 18 to 36 years.
  • Diagnosis of acute acromioclavicular joint injury confirmed by an orthopedic surgeon.
  • Physician-prescribed upper-limb immobilization using a sling for approximately 2 to 4 weeks, with or without surgical repair.
  • Ability to understand study procedures and provide written informed consent.
  • Medical clearance to participate in the rehabilitation and resistance training program.

Exclusion Criteria:

  • Previous surgery or severe musculoskeletal injury affecting either upper limb within the previous 12 months.
  • Neurological disorders affecting motor function or neuromuscular performance.
  • Contraindications to transcranial magnetic stimulation according to established safety guidelines.
  • Current participation in another clinical trial or structured upper-limb rehabilitation program.
  • Cognitive impairment or inability to comply with study procedures.
  • Pregnancy.
  • Any medical condition that, in the opinion of the investigators, may compromise participant safety or study participation.

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Contralateral Eccentric Training
Participants will perform supervised contralateral eccentric resistance training with the non-injured upper limb during the period of physician-prescribed sling immobilization following acute acromioclavicular joint injury, with or without surgical repair. The immobilization period is expected to last approximately 2 to 4 weeks depending on clinical management. Following immobilization, participants will complete a standardized 4-week rehabilitation program.
Conductual: Contralateral Eccentric Resistance Training
Supervised unilateral eccentric elbow flexor training performed with the non-injured limb during sling immobilization (2-4 weeks). Training is performed 3 times/week, 5 sets of 8-12 repetitions at 60-90% 1RM, with 4-second contractions and 3-minute rest intervals between sets.
Comparador activo: Contralateral Concentric Training
Participants will perform supervised contralateral concentric resistance training with the non-injured upper limb during the period of physician-prescribed sling immobilization following acute acromioclavicular joint injury, with or without surgical repair. The immobilization period is expected to last approximately 2 to 4 weeks depending on clinical management. Following immobilization, participants will complete the same standardized 4-week rehabilitation program.
Conductual: Contralateral Concentric Resistance Training
Supervised unilateral concentric elbow flexor training performed with the non-injured limb during sling immobilization (2-4 weeks). Training is performed 3 times/week, 5 sets of 8-12 repetitions at 60-90% 1RM, with 4-second contractions and 3-minute rest intervals between sets.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximal Voluntary Isometric Contraction
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Maximal voluntary isometric force of the injured upper limb assessed using a calibrated dynamometer. Force values will be recorded during standardized maximal isometric contractions and used to evaluate changes in muscle performance throughout immobilization and rehabilitation. Unit: Newtons (N)
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Rate of Force Development
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Rate of force development (RFD) of the injured upper limb assessed during maximal voluntary isometric contractions using a calibrated dynamometer. RFD will be calculated from the force-time curve and used as an indicator of explosive force production and neuromuscular performance. Unit: N·s-¹ (N/s)
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Elbow Flexors Voluntary Activation
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Voluntary activation of the elbow flexors assessed using the interpolated twitch technique during maximal voluntary isometric contractions. Values will be expressed as a percentage of voluntary neural drive to the muscle. Unit: %
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Motor Supramaximal Response Amplitude
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Peak-to-peak amplitude of the motor supramaximal response (MSUP) evoked by peripheral nerve stimulation during submaximal contractions as an indicator of motor pathway excitability. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Motor Evoked Potential Amplitude
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Motor evoked potential (MEP) amplitude elicited by transcranial magnetic stimulation and normalized to peripheral responses to assess corticospinal excitability. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Silent Period Duration
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Duration of the electromyographic silent period following transcranial magnetic stimulation during voluntary contractions as an indicator of cortical inhibition. Unit: ms
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Short-Interval Intracortical Inhibition
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Short-interval intracortical inhibition assessed using paired-pulse transcranial magnetic stimulation as an index of intracortical inhibitory function. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Cervicomedullary Motor Evoked Potential Amplitude
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Motor unit discharge characteristics assessed using high-density surface electromyography, including discharge rate, recruitment thresholds, and estimates of intrinsic motoneuron properties. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Motor Unit Behavior
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Motor unit discharge characteristics assessed using high-density surface electromyography, including discharge rate, recruitment thresholds, and estimates of intrinsic motoneuron properties. Unit: pulses/s (pps)
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii MMAX Amplitude
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Peak-to-peak amplitude of the maximal compound muscle action potential (MMAX) evoked by peripheral nerve stimulation as an indicator of peripheral excitability. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Peripheral Contractile Properties
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Evoked twitch and doublet force responses obtained using peripheral nerve stimulation to assess muscle contractile function. Unit: N
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Muscle Thickness
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Muscle thickness assessed by B-mode ultrasonography as an indicator of muscle morphology and preservation during immobilization and rehabilitation. Unit: mm
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Upper Limb Function (QuickDASH)
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Upper-limb disability and functional status assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Unit: 0-100 points
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Health-Related Quality of Life (SF-36)
Periodo de tiempo: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Unit: 0-100 points
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)

Colaboradores e Investigadores

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

Patrocinador

Universidad Nacional Andres Bello

Investigadores

  • Director de estudio: Claudio Chamorro Lange, PhD, Universidad Nacional Andres Bello
  • Director de estudio: Luis Peñailillo Escaráte, PhD, Universidad Nacional Andres Bello

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 enero de 2026

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • DI-03-CBC/22
  • 21261279 (Otro número de subvención/financiamiento: ANID/Beca de Doctorado Nacional 2026.Chile)
  • DI-07-25/INI (Otro número de subvención/financiamiento: Concurso de Iniciación a la Investigación UNAB 2025,Chile)
  • 24 010884 01 (Otro número de subvención/financiamiento: Programme Ambition International 2024, La Région Auvergne Rhône Alpes,France)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request. Shared data may include demographic characteristics, clinical outcomes, force production measurements, neuromuscular assessments, electromyographic recordings, transcranial magnetic stimulation outcomes, peripheral nerve stimulation outcomes, and questionnaire-derived scores. Data will be provided in a de-identified format to protect participant confidentiality.

Marco de tiempo para compartir IPD

Data will become available beginning 6 months following publication of the primary study results and will remain available for a period of 5 years.

Criterios de acceso compartido de IPD

Researchers who provide a methodologically sound proposal and whose intended use of the data has been approved by the study investigators may access the data. Requests should be directed to the Principal Investigator. Data will be shared through a secure institutional repository or encrypted electronic transfer following execution of an appropriate data-sharing agreement.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CÓDIGO_ANALÍTICO

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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