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临床试验/NCT00336089
NCT00336089Unknown不适用

The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors

Clayton State University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
54
试验地点
2

研究概览

简要总结

RATIONALE: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women who are breast cancer survivors.

PURPOSE: This randomized clinical trial is studying an exercise program to see how well it works in reducing fatigue and pain compared to a health education program or no program in women who are breast cancer survivors.

详细描述

OBJECTIVES:

  • Determine whether a moderate-intensity exercise program comprising cardiorespiratory and resistance training of the legs, back, abdominal, trunk, and arm musculature vs a control group attenuates fatigue and pain in breast cancer survivors.
  • Determine whether this exercise program will significantly improve the quality of life of these patients.
  • Determine whether this exercise program can significantly reduce the number of days of absenteeism from work in these patients.
  • Determine whether this exercise program can significantly attenuate mood disturbances in these patients.

OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (exercise program): Patients participate in an exercise program comprising cardiorespiratory (walking on a treadmill) and resistance training for 1 hour, 3 times weekly for 12 weeks.
  • Arm II (control): Patients undergo no intervention. In both arms, patients complete questionnaires regarding general health, mood, work attendance, and physical activity before the start of study treatment and then every 3 weeks for 12 weeks. Patients also complete a 7-day physical activity diary and sleep diary every 3 weeks.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •DISEASE CHARACTERISTICS:
  • •Breast cancer survivor
  • •Received adjuvant chemotherapy or radiotherapy for breast cancer only
  • •Must have completed treatment 2-6 months ago
  • •Hormone receptor status not specified
  • •PATIENT CHARACTERISTICS:
  • •Menopausal status not specified
  • •Hemoglobin ≥ 11 g/dL
  • •Able to read English
  • •No high-risk for cardiovascular problems during exercise, including any of the following:
  • •Unstable heart disease
  • •Unstable angina
  • •Chronic respiratory disease
  • •Dizziness
  • •Uncontrolled hypertension
  • •No severe respiratory disease requiring oxygen therapy
  • •No history of anorexia (body mass index [BMI] < 18.5) or severe obesity (BMI > 35)
  • •No history of multiple cancers
  • •No shortness of breath or hypotension
  • •No sudden swelling of the ankles, hands or face
  • •No palpitations or arrhythmias
  • •No persistent and intolerable pain
  • •No major acute illness (e.g., fever or respiratory infection)
  • •PRIOR CONCURRENT THERAPY:
  • •See Disease Characteristics

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (2)

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