The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema

Status Not yet recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05003973
Study type	Interventional
Source	National Cheng Kung University
Contact	Yu-Yun Hsu
Phone	+886-6-2353535
Email	yuht12@mail.ncku.edu.tw
Status	Not yet recruiting
Phase	N/A
Start date	August 20, 2021
Completion date	December 31, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms