The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
Primary Purpose
Gynecological Cancer, Lower Limb Lymphedema
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
home-based anti-resistance exercise
usually care
Sponsored by
About this trial
This is an interventional treatment trial for Gynecological Cancer focused on measuring Women's Health, Home-based Anti-Resistance Exercise
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
home-based anti-resistance exercise
usually care
Arm Description
Outcomes
Primary Outcome Measures
Limb circumference change from baseline to 3 months
Measuring by measuring tape
Edema change from baseline to 3 months
Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
Lower limb muscle strength change from baseline to 3 months
Measuring by microFET 2
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.
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.
EORTC-QLQ-C30
Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.
Secondary Outcome Measures
Full Information
NCT ID
NCT05003973
First Posted
July 26, 2021
Last Updated
August 12, 2021
Sponsor
National Cheng Kung University
1. Study Identification
Unique Protocol Identification Number
NCT05003973
Brief Title
The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
Official Title
The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 20, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecological Cancer, Lower Limb Lymphedema
Keywords
Women's Health, Home-based Anti-Resistance Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
home-based anti-resistance exercise
Arm Type
Experimental
Arm Title
usually care
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
home-based anti-resistance exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
usually care
Intervention Description
The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage
Primary Outcome Measure Information:
Title
Limb circumference change from baseline to 3 months
Description
Measuring by measuring tape
Time Frame
from baseline to 3 months
Title
Edema change from baseline to 3 months
Description
Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
Time Frame
from baseline to 3 months
Title
Lower limb muscle strength change from baseline to 3 months
Description
Measuring by microFET 2
Time Frame
from baseline to 3 months
Title
Functional status of lymphatic edema of LLL change from baseline to 3 months
Description
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.
Time Frame
from baseline to 3 months
Title
Fatigue change from baseline to 3 months
Description
Measuring by Chinese Lee Fatigue Scale Short Form (C-LESSF). It is a 7-item, from 0(no fatigue) to 10(very fatigue) questionnaire.
Time Frame
from baseline to 3 months
Title
EORTC-QLQ-C30
Description
Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.
Time Frame
from baseline to 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Yun Hsu
Phone
+886-6-2353535
Email
yuht12@mail.ncku.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
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