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

Arm | Intervention/treatment |
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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.
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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
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- Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise [ Time Frame: 1 year after randomization ]
- 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 ]

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

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
Contact: Myong Cheol Lim, MD, PhD | +82-31-920-1760 | gynlim@gmail.com | |
Contact: JeongSeon Lee | +82-31-920-1760 |
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 |
Principal Investigator: | Lim Myong Cheol, MD,PhD | National Cancer Center |
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 |
Lower extremity edema Lower leg lymphedema Lower leg edema |
Lymphedema Pelvic lymphadenectomy Exercise |
Edema |