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Aquatic Exercise Study for Breast Cancer Patients With Lymphedema


N/A
21 Years
90 Years
Not Enrolling
Both
Lymphedema

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction of Lymphedema

Outcome Description:

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

Outcome Time Frame:

baseline, week 6, month 6, and month 12

Safety Issue:

No

Principal Investigator

Michael Grant, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Sammons Breast Center

Authority:

United States: Institutional Review Board

Study ID:

Baylor IRB #006-116

NCT ID:

NCT00498771

Start Date:

July 2006

Completion Date:

June 2013

Related Keywords:

  • Lymphedema
  • Lymphedema
  • Aquatic Exercise
  • Breast Cancer
  • Breast Neoplasms
  • Lymphedema

Name

Location

Baylor Sammons Breast Center Dallas, Texas  75246