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Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer

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ClinicalTrials.gov Identifier: NCT01849224
Recruitment Status : Unknown
Verified July 2013 by Myong Cheol Lim, National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Myong Cheol Lim, National Cancer Center, Korea

Study Description
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Brief Summary:
The primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise.

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Other: Pelvic and lower extremity exercise Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms
Study Start Date : May 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pelvic and lower extremity exercise
Experimental arm will be educated the guidelines for prevention and early detection of lower extremity edema. Additionally, pelvic and lower extremity exercise will be educated and participants will continue exercise for 1 year at home.
 Other: Pelvic and lower extremity exercise
No Intervention: Control
Control group will be educated the guidelines for prevention and early detection of lower extremity edema


Outcome Measures
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Primary Outcome Measures :
  1. Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise [ Time Frame: 1 year after randomization ]

Secondary Outcome Measures :
  1. the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise [ Time Frame: 1 year after randomization ]

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

Inclusion Criteria:

  • More than 18 years of age
  • Patients who underwent pelvic lymphadenectomy
  • Patients with suspicious pelvic cancer who finished active treatments such as chemotherapy, radiotherapy or surgery. The interval between the time of randomization and the end of the treatment should be more than 2 weeks.
  • The patient is able to understand the study and is willing to give written informed consent to the study
  • patient with edema-related symptoms such as leg heaviness, distension, tightness, pain, limited movement, or weakness etc.

Exclusion Criteria:

  • Severe systemic diseases causing peripheral edema, including renal disease
  • Severe or uncontrolled cardiopulmonary disease, including implantable device such as a pacemaker
  • Acute superficial or deep vein thrombosis
  • Previous major surgery for lower extremities, including metallic surgical implant
  • Local infection in the lower extremities
  • Auto-immunological disorders or vasculitis
  • Use of systemic corticosteroids
  • Pregnant or currently breastfeeding
  • Alcohol or drug abuse
  • Uncontrolled diabetes
Contacts and Locations
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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): NCT01849224


Contacts
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Contact: Myong Cheol Lim, MD, PhD +82-31-920-1760 gynlim@gmail.com
Contact: JeongSeon Lee +82-31-920-1760

Locations
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Korea, Republic of
Myong Cheol Lim Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Myong Cheol Lim       gynlim@gmail.com   
Principal Investigator: Myong Cheol Lim         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Lim Myong Cheol, MD,PhD National Cancer Center
More Information
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Responsible Party: Myong Cheol Lim, Senior researcher, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01849224    
Other Study ID Numbers: NCCNCS-13-723
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013
Keywords provided by Myong Cheol Lim, National Cancer Center, Korea:
Lower extremity edema
Lower leg lymphedema
Lower leg edema
 Lymphedema
Pelvic lymphadenectomy
Exercise
Additional relevant MeSH terms:
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Edema