Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
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Purpose
The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.
| Condition | Intervention |
|---|---|
|
Lymphedema |
Behavioral: Aquatic Exercise arm |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aquatic Exercise Study for Breast Cancer Patients With Lymphedema |
- 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
| Enrollment: | 35 |
| Study Start Date: | July 2006 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, Texas | |
| Baylor Sammons Breast Center | |
| Dallas, Texas, United States, 75246 | |
| Principal Investigator: | Michael Grant, M.D. | Baylor Sammons Breast Center |
More Information
No publications provided
| Responsible Party: | Baylor Research Institute |
| ClinicalTrials.gov Identifier: | NCT00498771 History of Changes |
| Other Study ID Numbers: | Baylor IRB #006-116 |
| Study First Received: | July 9, 2007 |
| Last Updated: | June 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baylor Research Institute:
|
Lymphedema Aquatic Exercise Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Lymphedema Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Lymphatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013