Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

Lymphedema Clinical Trial

Official title:

Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498771
• Other study ID #: 006-116
• Status: Completed
• Phase: N/A
• First received: July 9, 2007
• Last updated: June 9, 2017
• Start date: July 2006
• Est. completion date: June 2013

Study information

• Verified date: June 2017
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema

Intervention

Behavioral:
• Aquatic Exercise arm
Participants will attend 12 classes of aquatic exercise program (2-3 classes/weekly). Each one hour class is held in warm water pool which is 89 degrees and 3.5'-4'deep.Classes include low impact, dynamic movements for warm up, stretching and breathing exercises, upper and lower body resistance training, and cool down activities. Participants will be evaluated for Circumference & volumetric measurement of the affected limb, BMI, weight and height at the baseline, at 3rd week and at 6th week. Participant will complete a quality of life survey (QOL)at baseline, 6 week, 6 and 12 month.

Locations

Country	Name	City	State
United States	Baylor Sammons Breast Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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