Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baylor Research Institute
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Reduction of Lymphedema
Study Overview
Brief Summary
The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Breast cancer patients with Lymphedema
- •Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study.
- •Patients undergoing treatment will require written permission from their physician
- •Complete an assessment by a licensed physical therapist before beginning the exercise program
- •Patients must sign a consent form to participate
Exclusion Criteria
- •Patients undergoing treatment without physician's written permission
- •Patients with health problems that contraindicate exercise
- •Patients are not eligible if the physical therapy assessment identifies a contraindication to participation
- •Inclusion of Women and Minorities:
- •Men, women and minorities with breast cancer related lymphedema are eligible
Outcomes
Primary Outcomes
Reduction of Lymphedema
Time Frame: baseline, week 6, month 6, and month 12
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
Secondary Outcomes
No secondary outcomes reported