Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy
6 de octubre de 2020 actualizado por: Qing Shu, Wuhan University
Effect of Exercise Training at Different Timeline on Shoulder Dysfunction in Patients After Breast Cancer Modified Radical Mastectomy: A Randomized Controlled Trial
Patients who underwent modified radical mastectomy were enrolled in the study.
200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group.
The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed.
The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.
Descripción general del estudio
Estado
Terminado
Tipo de estudio
Intervencionista
Inscripción (Actual)
200
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
-
-
Hubei
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Wuhan, Hubei, Porcelana, 430070
- Zhongnan Hospital of Wuhan University
-
-
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
25 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Between the ages of 25 and 75 years;
- Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
- Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
- Postoperative chemotherapy or radiation therapy according to the condition;
- No other malignant tumors within 5 years;
- No physical therapy related contraindications;
- Signing informed consent.
Exclusion Criteria:
- The result of SLNB is negative who did not receive ALND;
- Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
- Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
- Combined severe heart disease, cerebrovascular disease, and mental illness;
- Patients with shoulder joint dysfunction before surgery;
- Unable to understand the rehabilitation training program provided by doctors or physiotherapists.
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 |
|---|---|
|
Comparador activo: 7 days SIE plus 4 weeks PRE
Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
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Experimental: 7 days SIE plus 3 weeks PRE
Participants in this group will start shoulder isotonic exercise 7 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
Experimental: 3 days SIE plus 4 weeks PRE
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 4 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
|
Experimental: 3 days SIE plus 3 weeks PRE
Participants in this group will start shoulder isotonic exercise 3 days after surgery and begin progressive resistance exercise 3 weeks after surgery.
|
Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint. Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Constant-Murley Shoulder Score
Periodo de tiempo: 1 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
1 weeks after surgery
|
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Constant-Murley Shoulder Score
Periodo de tiempo: 3 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
3 weeks after surgery
|
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Constant-Murley Shoulder Score
Periodo de tiempo: 6 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
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6 weeks after surgery
|
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Constant-Murley Shoulder Score
Periodo de tiempo: 9 weeks after surgery
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The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
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9 weeks after surgery
|
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Constant-Murley Shoulder Score
Periodo de tiempo: 12 weeks after surgery
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The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
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12 weeks after surgery
|
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Constant-Murley Shoulder Score
Periodo de tiempo: 18 weeks after surgery
|
The shoulder function was evaluated by the total score of the Constant-Murley Shoulder Score Questionnaire, which ranged from 0 to 100.
Higher scores indicate better shoulder function.
|
18 weeks after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Active and passive range of motion
Periodo de tiempo: 3 days，1, 2, 3, 6, and 9 weeks after surgery
|
In the standard position, the mobility of the shoulder flexion, extension, external rotation and internal rotation was measured by using protractor.
The range of flexion is 0-180°, the range of extension is 0-180°, the range of external rotation is 0-90°, and the range of internal rotation is measured.
0-70°.
The assessments will be performed in the active and passive state separately.
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3 days，1, 2, 3, 6, and 9 weeks after surgery
|
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Shoulder joint muscle strength
Periodo de tiempo: 3 days, 3, 6, 9 weeks after surgery
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In the standard position, the muscle strength of the flexion, extension, external rotation and internal rotation of the shoulder joint were assessed according to the "manual muscle test standard".
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3 days, 3, 6, 9 weeks after surgery
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The power of gripping
Periodo de tiempo: 1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
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In the standard position, the grip of the patient's palm is measured using a dynamometer.
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1, 3 days and 1, 2, 3, 6, and 9 weeks after surgery
|
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EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire
Periodo de tiempo: 1, 3, 9, 12, 18 weeks after surgery
|
The quality of life assessment of breast cancer patients was evaluated by the total score of the EORTC QLQ BR23 Breast Cancer Quality of Life Questionnaire, which ranged from 0 to 92.
Higher scores indicate better quality of life.
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1, 3, 9, 12, 18 weeks after surgery
|
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SF-36 Health status questionnaire
Periodo de tiempo: 1, 3, 9, 12, 18 weeks after surgery
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The quality of life assessment of breast cancer patients was evaluated by the total score of the SF-36 Health status questionnaire, which ranged from 0 to 92.
Higher scores indicate better quality of life.
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1, 3, 9, 12, 18 weeks after surgery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visual Analogue Scale （VAS)
Periodo de tiempo: 1 day, 3 days, 1 week, 2 weeks after surgery
|
Visual Analogue Scale（VAS): Used to assess the degree of pain.
Draw a 10 cm horizontal line on the paper.
One end of the horizontal line is 0, indicating no pain; the other end is 10, indicating severe pain; the middle part indicates different degrees of pain.
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1 day, 3 days, 1 week, 2 weeks after surgery
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Sum drainage from chest wall and axillary after operation.
Periodo de tiempo: 1 day, 3 days, 1 week, 2 weeks after surgery
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The postoperative drainage was the total volume of the chest wall drainage tube and the underarm drainage tube.
The volume measurement and recording in the drainage bag were observed daily by the nurse.
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1 day, 3 days, 1 week, 2 weeks after surgery
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Upper limb circumference
Periodo de tiempo: Preoperative 3, 9, 12,18 weeks after surgery
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Preoperative 3, 9, 12,18 weeks after surgery
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|
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body weight
Periodo de tiempo: Preoperative, 3, 9 weeks after surgery
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Preoperative, 3, 9 weeks after surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el 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)
10 de septiembre de 2018
Finalización primaria (Actual)
31 de mayo de 2020
Finalización del estudio (Actual)
31 de mayo de 2020
Fechas de registro del estudio
Enviado por primera vez
29 de agosto de 2018
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2018
Publicado por primera vez (Actual)
5 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de octubre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
6 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRE2018013
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The study protocol, statistical analysis plan, informed consent form and clinical study report will be shared online about six months after the trial complete.
Marco de tiempo para compartir IPD
About six months after the trial complete
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
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. .