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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00935714
First Posted: July 9, 2009
Last Update Posted: August 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tel Aviv University
Information provided by:
Hillel Yaffe Medical Center
  Purpose
Arm exercise influences arm volume and symptoms in breast cancer related lymphedema.

Condition Intervention
Breast Cancer Lymphedema Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Improved arm volume measurement [ Time Frame: Weekly for five weeks ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Weekly for 5 weeks ]

Estimated Enrollment: 18
Study Start Date: August 2009
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Muscle Group
Exercise
Other: Exercise
Active Comparator: Sequence
Exercise
Other: Exercise

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935714


Contacts
Contact: Jillian H Bracha, BSc 972-523784551 gillianb@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Sub-Investigator: Jillian Bracha, RN         
Principal Investigator: Ehud Sternberg, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Tel Aviv University
  More Information

Responsible Party: Prof. A. Sternberg, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00935714     History of Changes
Other Study ID Numbers: 0023-09-HYMC
First Submitted: July 8, 2009
First Posted: July 9, 2009
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by Hillel Yaffe Medical Center:
Arm
Lymphedema
Breast Cancer
Exercise
Breast Cancer related Lymphedema

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases