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Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
This study is currently recruiting participants.
Verified by Baylor Research Institute, May 2008
Sponsored by: Baylor Research Institute
Information provided by: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00498771
  Purpose

The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.


Condition Intervention
Lymphedema
Behavioral: Exercise

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome
MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness Lymphedema
U.S. FDA Resources
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

Further study details as provided by Baylor Research Institute:

Estimated Enrollment: 100
Study Start Date: July 2006
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 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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498771

Contacts
Contact: Suzette Clark 214-820-8299 SuzetteC@baylorhealth.edu

Locations
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.            
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Michael Grant, M.D. Baylor Sammons Breast Center
  More Information

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

Keywords provided by Baylor Research Institute:
Lymphedema
Aquatic Exercise
Breast Cancer

Study placed in the following topic categories:
Lymphedema
Lymphatic Diseases
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009