Aquatic Exercise Study for Breast Cancer Patients With Lymphedema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00498771
First received: July 9, 2007
Last updated: June 17, 2013
Last verified: June 2013

July 9, 2007
June 17, 2013
July 2006
December 2009   (final data collection date for primary outcome measure)
Reduction of Lymphedema [ Time Frame: baseline, week 6, month 6, and month 12 ] [ Designated as safety issue: No ]
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
Not Provided
Complete list of historical versions of study NCT00498771 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphedema
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.
  • Active Comparator: 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: Behavioral: Aquatic Exercise arm
  • No Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
June 2013
December 2009   (final data collection date for primary outcome measure)

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

Both
21 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00498771
Baylor IRB #006-116
No
Baylor Research Institute
Baylor Research Institute
Not Provided
Principal Investigator: Michael Grant, M.D. Baylor Sammons Breast Center
Baylor Research Institute
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP