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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01849224

Enrollment

148

Registered

2013-05-08

Start date

2013-05-31

Completion date

2015-12-31

Last updated

2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancer

Keywords

Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymphadenectomy, Exercise

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.

Interventions

OTHERPelvic and lower extremity exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise	1 year after randomization

Secondary

Measure	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

Countries

South Korea

Contacts

Primary ContactMyong Cheol Lim, MD, PhD

gynlim@gmail.com+82-31-920-1760

Backup ContactJeongSeon Lee

+82-31-920-1760

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026