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

Gynecological Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05003973
• Other study ID #: A-ER-107-433
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: National Cheng Kung University
• Contact: Yu-Yun Hsu
• Phone: +886-6-2353535
• Email: yuht12[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecological Cancer
• Lymphedema

Intervention

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.
• usually care
The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Outcome

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