- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00498771
Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
Descripción general del estudio
Descripción detallada
This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema. The study is designed for breast cancer patients who have developed Lymphedema following cancer treatment. Potential study participants should have explored conventional treatments such as decongestive therapy and lymph drainage massage before joining the study.
There are two groups that the participants may choose from until enrollment for the group has reached its capacity.The active arm of the study will attend 12 one-hour aquatic exercise classes and classes will be held in an indoor heated pool. There is no cost to the participants.Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments that will compare the circumference and volumetric measurement of arms, as well as height, weight and body mass index (BMI).
Both group will fill out a program questionnaire. Quality of life survey taken at baseline, week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6 and 12 month intervals, and annually for five years.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Dallas, Texas, Estados Unidos, 75246
- Baylor Sammons Breast Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Breast cancer patients with Lymphedema
- Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study.
- Patients undergoing treatment will require written permission from their physician
- Complete an assessment by a licensed physical therapist before beginning the exercise program
- Patients must sign a consent form to participate
Exclusion Criteria:
- Patients undergoing treatment without physician's written permission
- Patients with health problems that contraindicate exercise
- Patients are not eligible if the physical therapy assessment identifies a contraindication to participation
Inclusion of Women and Minorities:
- Men, women and minorities with breast cancer related lymphedema are eligible
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Aquatic Exercise arm
Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly).
Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities.
Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week.
Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
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Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly).
Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities.
Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week.
Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.
|
Sin intervención: Control - No Exercise Arm
No exercise will be performed in Control arm.
Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week.
Participant will complete a quality of life survey (QOL) at baseline, 6 week, 6 and 12 month.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Reduction of Lymphedema
Periodo de tiempo: baseline, week 6, month 6, and month 12
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Comparison of the circumference and volumetric measurements of the affected limb will be made prior to, midpoint and at completion of the 12 class program.
Quality of life surveys taken at baseline, week 6, month 6 and 12 will be compared
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baseline, week 6, month 6, and month 12
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael Grant, M.D., Baylor Sammons Breast Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- 006-116
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.
producto fabricado y exportado desde los EE. UU.
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