Effect of Exercise Mode in Breast Cancer-Related Lymphedema (Lymphedema)
8 de septiembre de 2021 actualizado por: Maged Basha, Qassim University
Effect of Exercise Mode on Physical Function and Quality of Life in Breast Cancer-Related Lymphedema: A Randomized Controlled Trial
Gaining a greater understanding of how each exercise mode affects lymphedema, as well as other health-related outcomes will improve exercise prescription guidelines relevant to this specific lymphedema.
Therefore, the purpose of this work was to compare the effects of Xbox kinect rehabilitation and resistance exercises on limb volume, symptoms severity, physical function, and quality of life in women with Breast cancer-related lymphedema.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Breast cancer-related lymphedema is a common and debilitating side effect of cancer treatment.
This study compared the effect of Xbox kinect rehabilitation and resistance exercises on breast cancer-related lymphedema volume and severity, as well as participant's physical function and quality of life.
Women diagnosed with unilateral breast cancer related lymphedema were randomly divided into two groups: the kinect based rehabilitation group KBRG and resistance exercise group REG.
woman in The KBRG received virtual reality therapy using Xbox Kinect-based games, the REG received resistance training in addition both groups received complex decongestive physiotherapy.
The intervention was five sessions per week for 8 weeks.
The outcome measures included limb volume, symptoms severity, physical function (muscle strength and range of motion) and quality of life.
All these outcomes were assessed at pretreatment (baseline) and after the end of treatment at week eight (W8).
Tipo de estudio
Intervencionista
Inscripción (Actual)
52
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
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Cairo, Egipto, 11241
- Shorook Physical Therapy Centers
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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
30 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Age more than 30.
- Histological diagnosis of breast cancer at least 1 year prior to the study.
- Clinical diagnosis of unilateral Breast cancer-related lymphedema and obtained medical clearance from their medical oncologists or surgeons.
- Clinical diagnosis of lymphedema was defined as having at least a 5 % inter-limb discrepancy in volume or circumference.
Exclusion Criteria:
- Unstable lymphedema, receiving intensive therapy within the previous 3 months.
- A musculoskeletal, cardiovascular and/or neurological disorder that could inhibit them from exercising.
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 |
|---|---|
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Experimental: Virtual Reality Group
The Kinect based rehabilitation group received virtual reality therapy using Xbox Kinect-based games, in addition to complex decongestive physiotherapy.
The intervention was led once per day, five days a week, over 8 weeks.
All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.
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Intervention was led once per day, five days a week, over 8 weeks.
Otros nombres:
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Experimental: Resistance exercise Group
The resistance exercise group received resistance training, in addition to complex decongestive physiotherapy.
The intervention was led once per day, five days a week, over 8 weeks.
All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.
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Intervention was led once per day, five days a week, over 8 weeks.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Limb volume measurement
Periodo de tiempo: at baseline
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assessed by circumference measurements using a non-elastic tape.
Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
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at baseline
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Limb volume measurement
Periodo de tiempo: after 8 weeks
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assessed by circumference measurements using a non-elastic tape.
Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
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after 8 weeks
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Limb volume measurement
Periodo de tiempo: after 12 weeks
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assessed by circumference measurements using a non-elastic tape.
Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
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after 12 weeks
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Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Periodo de tiempo: at baseline
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assessed using the Medical Outcomes Study short-form (SF-36).
Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
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at baseline
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Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Periodo de tiempo: after 8 weeks
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assessed using the Medical Outcomes Study short-form (SF-36).
Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
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after 8 weeks
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Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Periodo de tiempo: after 12 weeks
|
assessed using the Medical Outcomes Study short-form (SF-36).
Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
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after 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder range of motion
Periodo de tiempo: at baseline
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Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position.
External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
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at baseline
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Shoulder range of motion
Periodo de tiempo: after 8 weeks
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Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position.
External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
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after 8 weeks
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Shoulder range of motion
Periodo de tiempo: after 12 weeks
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Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position.
External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
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after 12 weeks
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Visual analogue scale
Periodo de tiempo: at baseline
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used to quantify the severity of perceived pain, heaviness, and tightness.
Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
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at baseline
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Visual analogue scale
Periodo de tiempo: after 8 weeks
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used to quantify the severity of perceived pain, heaviness, and tightness.
Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
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after 8 weeks
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Visual analogue scale
Periodo de tiempo: after 12 weeks
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used to quantify the severity of perceived pain, heaviness, and tightness.
Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
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after 12 weeks
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Muscle strength
Periodo de tiempo: at baseline
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The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
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at baseline
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Muscle strength
Periodo de tiempo: after 8 weeks
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The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
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after 8 weeks
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Muscle strength
Periodo de tiempo: after 12 weeks
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The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
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after 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maged Basha, PhD, College of medical rehabilitation, Qassim University
- Director de estudio: Fatma Alzahraa Kamel, PhD, Cairo University
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.
Publicaciones Generales
- Vicini F, Shah C, Arthur D. The Increasing Role of Lymphedema Screening, Diagnosis and Management as Part of Evidence-Based Guidelines for Breast Cancer Care. Breast J. 2016 May;22(3):358-9. doi: 10.1111/tbj.12586. Epub 2016 Feb 29. No abstract available.
- Morgan PA, Franks PJ, Moffatt CJ. Health-related quality of life with lymphoedema: a review of the literature. Int Wound J. 2005 Mar;2(1):47-62. doi: 10.1111/j.1742-4801.2005.00066.x.
- Aguilar-Lazcano CA, Rechy-Ramirez EJ, Hu H, Rios-Figueroa HV, Marin-Hernandez A. Interaction Modalities Used on Serious Games for Upper Limb Rehabilitation: A Systematic Review. Games Health J. 2019 Oct;8(5):313-325. doi: 10.1089/g4h.2018.0129. Epub 2019 Jul 9.
- Basha MA, Aboelnour NH, Alsharidah AS, Kamel FH. Effect of exercise mode on physical function and quality of life in breast cancer-related lymphedema: a randomized trial. Support Care Cancer. 2022 Mar;30(3):2101-2110. doi: 10.1007/s00520-021-06559-1. Epub 2021 Oct 20.
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)
15 de enero de 2019
Finalización primaria (Actual)
20 de abril de 2020
Finalización del estudio (Actual)
5 de mayo de 2020
Fechas de registro del estudio
Enviado por primera vez
21 de enero de 2021
Primero enviado que cumplió con los criterios de control de calidad
21 de enero de 2021
Publicado por primera vez (Actual)
26 de enero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2021
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2449PT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Marco de tiempo para compartir IPD
6 months after publication
Criterios de acceso compartido de IPD
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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
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