Exercise and Breast Cancer Related Lymphedema: Influence of Muscle Group and Sequence on Volume Change in Swollen and Normal Arms

August 18, 2009 updated by: Hillel Yaffe Medical Center
Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Recruiting
        • Hillel Yaffe Medical Center
        • Sub-Investigator:
          • Jillian Bracha, RN
        • Principal Investigator:
          • Ehud Sternberg, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • unilateral arm lymphedema as a result of breast cancer treatment
  • completion of breast cancer treatments
  • arm lymphedema onset 3 months or more after surgery and persistent for at least 6 months
  • in the maintenance phase of lymphedema treatment

Exclusion Criteria:

  • women with recurrent cancer
  • intercurrent diseases affecting the swollen arm
  • lack of understanding of the Hebrew language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Muscle Group
Exercise
Other: Exercise
ACTIVE_COMPARATOR: Sequence
Exercise
Other: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improved arm volume measurement
Time Frame: Weekly for five weeks
Weekly for five weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: Weekly for 5 weeks
Weekly for 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Collaborators

Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2010

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (ESTIMATE)

July 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2009

Last Update Submitted That Met QC Criteria

August 18, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0023-09-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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