Exercise and Breast Cancer Related Lymphedema: Influence... | NCT00935714

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

NCT00935714

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Aug 19, 2009Estimated

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Breast Cancer
Lymphedema

Interventions

Exercise
Exercise

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Not provided

First Submitted Date

Jul 8, 2009

First Submission Date that Met QC Criteria

Jul 8, 2009

First Posted Date

Jul 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2009

Last Update Posted Date

Aug 19, 2009Estimated

Name	Class
Tel Aviv University	OTHER

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Muscle Group	Active Comparator	Exercise	Other: Exercise
Sequence	Active Comparator	Exercise	Other: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other		Muscle Group
Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improved arm volume measurement		Weekly for five weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life		Weekly for 5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jillian H Bracha, BSc	Contact	972-523784551		gillianb@hy.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center	Recruiting	Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D008209	Lymphedema
D009043	Motor Activity
D000072656	Breast Cancer Lymphedema

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided