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Effectiveness of Two Exercises in Preventing Lower-Limb Lymphedema After Gynecological Cancer Surgery

NCT05666947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-20

No results posted yet for this study

Summary

Background:

Lower-limb lymphedema is one of the complications after gynecological cancer surgery. Patients with lymphedema are more likely to limit their daily life activities and become inactive, leading to negative influences on quality of life. Although studies on resistance exercise primarily focus on the upper limb, there scarce evidence of the application of this exercise to the lower limb has been reported.

Objective:

This study will aim to compare the effect of resistance and non-resistance exercises in the prevention of lower-limb lymphedema, increasing self-management, and improving the quality of life of the patients following gynecological cancer surgery.

Design:

A single-blinded randomized controlled trial.

Settings and participants:

Sixty patients with gynecological cancer will recruit from a gynecological ward and will be randomly assigned to the elastic-band resistance exercise group (experimental group, n = 30) or conventional non-resistance exercise group (control group, n = 30).

Methods:

Both groups will receive one-to-one training about upper and lower limb exercises within 1 week after surgery. Each exercise will consist of a 5-minute warm-up session, a 20-minute main session, and a relaxing session. Patients in the experimental group will use an elastic band and change the elastic band from low to medium resistance. Patients in the experimental and control groups will receive guidelines from a booklet and video about elastic-band resistance and conventional non-resistance exercise, respectively. All patients will be evaluated at three-time points: T0-within 1 week after surgery and before the intervention, T1-10-11 weeks after surgery and within 1 week after intervention, T2-3 months after intervention using Lymph-ICF-LL scale, EORTC QLQ-C30 questionnaire, limb circumference measurements, and lymph self-management questionnaire. The Chi-square test, Fisher's exact test, the Mann-Whitney U-test, and the Generalized Estimating Equations will be used for the statistical analysis of the data.

Anticipated Outcomes: Findings from this study could provide a reference for home-based resistance exercise guidelines and be integrated into the care of activities for women following gynecological surgery with lower-limb lymphoedema.

Conditions

  • Lymphedema of Leg
  • Gynecologic Cancer
  • Exercise

Interventions

OTHER

Home-based exercise

Eight weeks of home-based exercise programs

Sponsors & Collaborators

  • Yu-Yun Hsu

    lead OTHER

Principal Investigators

  • Yu-Yun Hsu · National Cheng Kung University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05666947 on ClinicalTrials.gov