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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Other: Pelvic and lower extremity exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic and lower extremity exercise<br>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<br> <br> |
| No Intervention: Control<br>Control group will be educated the guidelines for prevention and early detection of lower extremity edema | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise |  | 1 year after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise |  | 1 year after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymphadenectomy, Exercise