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Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00498771
Enrollment
35
Registered
2007-07-10
Start date
2006-07-31
Completion date
2013-06-30
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Keywords

Lymphedema, Aquatic Exercise, Breast Cancer

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.

Interventions

BEHAVIORALAquatic 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.

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Reduction of Lymphedemabaseline, week 6, month 6, and month 12Comparison 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026