NCT00498771

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

3.4 years

First QC Date

July 9, 2007

Last Update Submit

June 9, 2017

Conditions

Lymphedema

Keywords

LymphedemaAquatic ExerciseBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Reduction of Lymphedema

    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

    baseline, week 6, month 6, and month 12

Study Arms (2)

Aquatic Exercise arm

ACTIVE COMPARATOR

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

Control - No Exercise Arm

NO INTERVENTION

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.

Interventions

Aquatic Exercise armBEHAVIORAL

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.

Aquatic Exercise arm

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Sammons Breast Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Grant, M.D.

    Baylor Sammons Breast Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

July 1, 2006

Primary Completion

December 1, 2009

Study Completion

June 1, 2013

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

US(1)