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Sponsored by: |
Baylor Research Institute |
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Information provided by: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT00498771 |
The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.
Condition | Intervention |
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Lymphedema |
Behavioral: Exercise |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Aquatic Exercise Study for Breast Cancer Patients With Lymphedema |
Estimated Enrollment: | 100 |
Study Start Date: | July 2006 |
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 at the Tom Landry Fitness Center. There is no cost to the participants and classes will be held in an indoor heated pool.
Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments, which will compare the circumference and volumetric measurement of both arms, as well as height, weight and body mass index (BMI).
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. Body mass index will be taken during the same time frames.
Both groups will also fill out questionnaires. Quality of life surveys taken at baseline, week 6, month 6 and 12 will be compared. Exercise History Questionnaires will be completed at 6 and 12 month intervals and annually for five years.
Ages Eligible for Study: | 21 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Suzette Clark | 214-820-8299 | SuzetteC@baylorhealth.edu |
United States, Texas | |
Baylor Sammons Breast Center | Recruiting |
Dallas, Texas, United States, 75246 | |
Contact: Suzette Clark 214-820-8299 SuzetteC@baylorhealth.edu | |
Principal Investigator: Michael D. Grant, M.D. |
Principal Investigator: | Michael Grant, M.D. | Baylor Sammons Breast Center |
Study ID Numbers: | Baylor IRB #006-116 |
Study First Received: | July 9, 2007 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00498771 |
Health Authority: | United States: Institutional Review Board |
Lymphedema Aquatic Exercise Breast Cancer |
Lymphedema Lymphatic Diseases Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |