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 because the information has not been verified recently.
Verified August 2009 by Hillel Yaffe Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tel Aviv University
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00935714
First received: July 8, 2009
Last updated: August 18, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Weekly for 5 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Prof. A. Sternberg, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00935714     History of Changes
Other Study ID Numbers: 0023-09-HYMC
Study First Received: July 8, 2009
Last Updated: August 18, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014