Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
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 and classes will be held in an indoor heated pool. There is no cost to the
participants.Both the active arm and the control group (not attending aquatic exercise
classes) will have 3 measurement assessments that will compare the circumference and
volumetric measurement of arms, as well as height, weight and body mass index (BMI).
Both group will fill out a program questionnaire. Quality of life survey taken at baseline,
week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6
and 12 month intervals, and annually for five years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction of Lymphedema
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. Quality of life surveys taken at baseline, week 6, month 6 and 12 will be compared
baseline, week 6, month 6, and month 12
No
Michael Grant, M.D.
Principal Investigator
Baylor Sammons Breast Center
United States: Institutional Review Board
Baylor IRB #006-116
NCT00498771
July 2006
June 2013
Name | Location |
---|---|
Baylor Sammons Breast Center | Dallas, Texas 75246 |