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Physical Activity, Fatigue, Sleep, and Inflammation (ABLE)

7 de marzo de 2016 actualizado por: University of Alabama at Birmingham

Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms

The purpose of the study is to examine the benefits of physical activity for breast cancer survivors related to muscle strength, tiredness, and sleep quality. Also, the study will determine the potential role of inflammation in these benefits.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Our previous research has shown that increases in physical activity can improve the health and well-being of breast cancer survivors. The current study will determine whether the physical activity increases are adequate for improved health by measuring physical activity (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies have examined cytokine changes in cancer survivors after participation in a physical activity behavior change intervention with a mechanistic focus on cytokines which may influence the muscle strength, fatigue, and sleep response to the intervention.

Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of Springfield, IL. Participants will be in the study for approximately 5 months. Participants will be asked to complete a questionnaire at the beginning of the study and 3 months later. A blood sample will be drawn to determine serum cytokine levels.

Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will participate in a 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands.

This randomized controlled trial includes the following study aims:

Study aim 1: The intervention group will be compared with the control group to examine the change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after participation in a physical activity intervention.

Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity intervention on muscle strength, fatigue, and sleep, we will compare the intervention group with the control group in terms of changes in cytokine markers of inflammation and evaluate whether such changes are consistent with and may mediate changes in muscle strength, fatigue, and sleep dysfunction.

Tipo de estudio

Intervencionista

Inscripción (Actual)

49

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

    • Illinois
      • Springfield, Illinois, Estados Unidos, 62702
        • Southern Illinois University School of Medicine

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 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Female, 30 to 70 years of age, with first diagnosis of ductal carcinoma in situ (DCIS) or Stage I or Stage II breast cancer
  • If chemotherapy or radiation therapy was received, the patient must be at least 4 weeks status post final primary treatment administration to allow treatment related cytokine changes to resolve. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
  • If the patient has undergone a surgical procedure, she must be at least 8 weeks post-procedure.
  • English speaking
  • Medical clearance for participation provided by primary care physician or oncologist
  • Postmenopausal
  • Average fatigue over the past week of ≥ 3 on a 1 to 10 Likert scale or sleep dysfunction ≥ 1 on a 0 to 3 Likert scale
  • Participating, on average, in no more than 20 minutes of physical activity on two or fewer days per week during the past six months
  • Willing to abstain from "as needed" medications for 7 days prior to each blood draw. "As needed" medications are defined as any medicine (prescription or over-the-counter) that is taken sporadically as needed for specific complaints rather than taken at regularly scheduled intervals (e.g., daily).

Exclusion Criteria:

  • Metastatic or recurrent breast cancer
  • Inability to ambulate without assistance
  • Unstable angina
  • New York Heart Association class II, III, or IV congestive heart failure
  • Uncontrolled asthma
  • Interstitial lung disease
  • Current use of steroids
  • Having been told by a physician to only do exercise prescribed by a physician
  • Dementia or organic brain syndrome
  • Schizophrenia or active psychosis
  • Connective tissue or rheumatologic disease [i.e., Systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, progressive systemic sclerosis, CREST syndrome, polymyositis, dermatomyositis, vasculitis, polymyalgia rheumatic, temporal arteritis]
  • Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
  • Do not live or work less than 50 miles from the study site
  • Lack of transportation to the study site
  • Changes in usual medications expected during the study time period
  • Plan to move residence out of the local area during the 5 months of the study
  • Plan to travel out of the local area for vacation during the first 4 weeks of the intervention or plan to travel out of the local area for more than a week during the last 8 weeks of the intervention
  • Contraindication to participation in physical activity (i.e., moderate intensity walking and strength training with resistance bands)

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control
no physical activity intervention
Experimental: Exercise intervention
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
Otros nombres:
  • ejercicio

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
physical activity
Periodo de tiempo: baseline and 3 months
The intervention group will be compared with the control group to examine the change in physical activity, before and after participation in a physical activity intervention. Participants are in the study for approximately 5 months. Assessments will be conducted at baseline, and following the 3 month exercise intervention.
baseline and 3 months
muscle strength
Periodo de tiempo: baseline and 3 months
The intervention group will be compared with the control group to examine the change in muscle strength before and after participation in a physical activity intervention.
baseline and 3 months
fatigue
Periodo de tiempo: baseline and 3 months
The intervention group will be compared with the control group to examine the change in fatigue before and after participation in a physical activity intervention.
baseline and 3 months
sleep dysfunction
Periodo de tiempo: baseline and 3 months
The intervention group will be compared with the control group to examine the change in sleep dysfunction before and after participation in a physical activity intervention.
baseline and 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
inflammatory markers (serum cytokine levels)
Periodo de tiempo: baseline and 3 months
The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected.
baseline and 3 months

Colaboradores e Investigadores

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

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

1 de agosto de 2010

Finalización primaria (Actual)

1 de diciembre de 2013

Finalización del estudio (Actual)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2010

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2010

Publicado por primera vez (Estimar)

22 de junio de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de marzo de 2016

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

7 de marzo de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • ROG-SCCI-10-004-1
  • R21CA135017-01A2 (Subvención/contrato del NIH de EE. UU.)

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. .

Ensayos clínicos sobre Cáncer de mama

Ensayos clínicos sobre 3 month physical activity intervention

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