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

Not Applicable

• Conditions: Gynecological Cancer; Lower Limb Lymphedema
• Interventions: Behavioral: usually care; Behavioral: home-based anti-resistance exercise

• Registration Number: NCT05003973
• Lead Sponsor: National Cheng Kung University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-26
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Study First Posted: 2021-08-13
• Last Update Posted: 2021-08-13
• Study Start: 2021-08-20
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usually care	usually care	-
home-based anti-resistance exercise	home-based anti-resistance exercise	-
home-based anti-resistance exercise	usually care	-

Primary Outcome Measures

Name	Time	Method
Lower limb muscle strength change from baseline to 3 months	from baseline to 3 months	Measuring by microFET 2
Limb circumference change from baseline to 3 months	from baseline to 3 months	Measuring by measuring tape
Fatigue change from baseline to 3 months	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.
Edema change from baseline to 3 months	from baseline to 3 months	Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
EORTC-QLQ-C30	from baseline to 3 months	Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.
Functional status of lymphatic edema of LLL change from baseline to 3 months	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.