Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

NCT ID: NCT00498771

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2013-06-30

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.

Conditions

Lymphedema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aquatic Exercise arm

Intervention Type: BEHAVIORAL

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.

Control - No Exercise Arm

No exercise will be performed in Control arm. 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

Inclusion of Women and Minorities:

• Men, women and minorities with breast cancer related lymphedema are eligible

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Grant, M.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor Sammons Breast Center

Locations

Baylor Sammons Breast Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

006-116

Identifier Type: -

Identifier Source: org_study_id