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Completed

NCT Number: NCT00498771

Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

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

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Sammons Breast Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquatic Exercise arm

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.

Primary outcomes

  1. Reduction of Lymphedema

    Time frame: baseline, week 6, month 6, and month 12

    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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2013
First posted
Jul 10, 2007
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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