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Sponsors and Collaborators: |
University of Pennsylvania National Institutes of Health (NIH) |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00194363 |
The purpose of the PAL trial is to increase the understanding of the experiences of long-term breast cancer survivors.
Study hypothesis: Strength training will not increase the rate of lymphedema or worsen lymphedema as compared to the non-exercising control participants.
Condition | Intervention |
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Lymphedema |
Behavioral: Strength training |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | The PAL Trial (Physical Activity and Lymphedema) |
Enrollment: | 295 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Women with lymphedema must have stable lymphedema. ONE of the following:
6-40% girth volume difference between the affected and non- affected limb for a dominant arm inter-limb discrepancy in volume or circumference at the point of greatest visible difference OR swelling or obscuration of anatomic architecture upon close inspection OR pitting edema.
As well as ALL of the following four conditions:
Women with Lymphedema must have ALL of the following:
Exclusion Criteria:
For ALL participants (with and without lymphedema)
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Kathryn Schmitz, PhD, MPH | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Kathryn H. Schmitz/Principal Investigator ) |
Study ID Numbers: | R01 CA-106851-01 |
Study First Received: | September 13, 2005 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00194363 |
Health Authority: | United States: Institutional Review Board |
breast cancer breast cancer survivors lymphedema strength training breast cancer survivorship |
Lymphedema Lymphatic Diseases Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |