The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer

August 12, 2021 updated by: Yu-Yun Hsu, National Cheng Kung University

Background:

The incidence of lower limb lymphedema (LLL) after gynecological cancer surgery with lymphadenectomy is about 10-46%. Lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. A hospital -based complete decongestive therapy has been recommended to patients with LLL, including exercise, manual lymphatic drainage, compression therapy, and skin care. However, the inconvenience of the hospital-based rehabilitation program limit the availability for those patients LLL. Home-based exercise program may be feasible instead of the hospital-based program. Few studies have evaluated the effectiveness of the home-based lower extremity exercise on reliving LLL and improving quality of life in patients with LLL.

Research Purposes:

The main purpose of the study is to evaluate the effectiveness of a home-based exercise program for relieving lower extremity lymphedema, including circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, quality of life related to cancer & LLL, and fatigue.

Methods:

This study is a two- year project with a single-blind randomized clinical trial. The participants are women with gynecological cancer surgery, aged of 20-75 years and currently have lower extremity lymphedema. A sample of 76 participants will be stratified randomly assigned to an experimental group or a control group. The experimental group is to carry out a home-based anti-resistance exercise with elastic band other than a routine care of complex decongestive physiotherapy; while the control group is to carry out a routine care of complex decongestive physiotherapy. The home-based program is a 12-week exercise program. Data collections will be conducted before exercise (Baseline), during exercise (second months), and exercise program after completion. Measures includes (1) Physical examination: limb leg circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, (2) Questionnaires: Functional status of lymphatic edema of LLL, fatigue, and EORTC-QLQ-C30.

Anticipated Outcomes:

Findings from this study could provide a reference of home-based exercise guideline and be integrated into the care of activities for women following gynecological surgery with LLL.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with gynecological cancer surgery
  • aged of 20-75 years
  • currently have lower extremity lymphedema.

Exclusion Criteria:

  • heart failure
  • kidney failure
  • DVT
  • limb surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: home-based anti-resistance exercise
Behavioral: home-based anti-resistance exercise
It is a 12-week, middle-level, home-based, anti-resistance exercise. Exercise was recommended 1-2 times per day for 15-20 mins per session.
Behavioral: usually care
The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage
Experimental: usually care
Behavioral: usually care
The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb circumference change from baseline to 3 months
Time Frame: from baseline to 3 months
Measuring by measuring tape
from baseline to 3 months
Edema change from baseline to 3 months
Time Frame: from baseline to 3 months
Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
from baseline to 3 months
Lower limb muscle strength change from baseline to 3 months
Time Frame: from baseline to 3 months
Measuring by microFET 2
from baseline to 3 months
Functional status of lymphatic edema of LLL change from baseline to 3 months
Time Frame: from baseline to 3 months
Measuring by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL). It is a 28-item, 0(no problem) to 10(very severe) questionnaire.
from baseline to 3 months
Fatigue change from baseline to 3 months
Time Frame: from baseline to 3 months
Measuring by Chinese Lee Fatigue Scale Short Form (C-LESSF). It is a 7-item, from 0(no fatigue) to 10(very fatigue) questionnaire.
from baseline to 3 months
EORTC-QLQ-C30
Time Frame: from baseline to 3 months
Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.
from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng Kung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 20, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 12, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-107-433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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