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| Descriptive Information Fields | |||||
| Brief Title † | Aerobic Exercise, Resistance Exercise, or Flexibility and Relaxation Training in Inactive Older Female Breast Cancer Survivors | ||||
| Official Title † | Comparison of Aerobic and Resistance Exercise in Older Breast Cancer Survivors | ||||
| Brief Summary | RATIONALE: Aerobic exercise, resistance exercise, and flexibility and relaxation training may reduce fatigue and improve the health and quality of life of breast cancer survivors. It is not yet known which type of exercise is more effective for inactive older female breast cancer survivors. PURPOSE: This randomized clinical trial is studying aerobic exercise to see how well it works compared with resistance exercise or flexibility and relaxation training in improving the health and quality of life of inactive older female breast cancer survivors. |
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| Detailed Description | OBJECTIVES: Primary:
Secondary:
OUTLINE: Patients are stratified according to current use of hormone manipulation therapy (none vs tamoxifen vs arimidex). Patients are randomized to 1 of 3 intervention arms.
Muscle strength (measured by a one-repetition maximum test), aerobic capacity (measured by a 6-minute walk test), functional arm strength (measured by grip dynamometer), physical functioning (measured by the Physical Performance Battery), flexibility (measured by the Chair Sit and Reach Test and the Back Scratch Test), balance (measured by a one-legged stance [Romberg] test and a timed stance test), lymphedema (measured by the circumference of the upper arm, wrist, and a finger), body composition (measured by dual energy x-ray absorptiometry), and bone mineral density of the heel (measured by ultrasound) are assessed at baseline and periodically during the study. Patients also undergo blood and urine sample collection for cancer recurrence biomarker and bone remodeling biomarker studies. Patients complete questionnaires at baseline and periodically during the study to assess demographic (i.e., age, income) and disease-specific (i.e., stage, treatment) variables, self-report mental and physical function, presence of chronic medical conditions, symptoms, fatigue, exercise outside the study exercise intervention, dietary intake, and psychosocial function. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care, Randomized, Active Control | ||||
| Primary Outcome Measure † | Comparison of the effects of aerobic exercise vs flexibility and relaxation training (control) on fatigue, aerobic capacity, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ] Comparison of the effects of resistance exercise vs flexibility and relaxation training (control) on fatigue, muscle strength, functioning, and health outcomes as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Comparison of the relative effects of aerobic exercise vs resistance exercise on fatigue, physical functioning, physical health, and mental health as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ] Determination of the mediating effects of fatigue and fitness on the relationship between exercise and physical functioning as measured at baseline and at 3, 6, 12, and 18 months [ Designated as safety issue: No ] Comparison of the individual and relative effects of aerobic exercise vs resistance exercise vs flexibility and relaxation training (control) on body composition and on biomarkers of cancer recurrence as measured at baseline and at 3, 6, 12, and 18 ... [ Designated as safety issue: No ] |
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| Condition † | Breast Cancer Cancer-Related Problem/Condition Fatigue |
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| Intervention † | Procedure: assessment of therapy complications Procedure: exercise intervention Procedure: fatigue assessment and management Procedure: laboratory biomarker analysis Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: questionnaire administration Procedure: survey administration |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 141 | ||||
| Start Date † | March 2008 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Female | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00662103 | ||||
| Organization ID | CDR0000593410 | ||||
| Secondary IDs †† | OHSU-CR00005268, OHSU-IRB00003316 | ||||
| Study Sponsor † | Oregon Health and Science University Cancer Institute | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 18, 2008 | ||||
| Last Updated Date | October 17, 2008 | ||||