The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Limb circumference change from baseline to 3 months [from baseline to 3 months]
Measuring by measuring tape
- Edema change from baseline to 3 months [from baseline to 3 months]
Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
- Lower limb muscle strength change from baseline to 3 months [from baseline to 3 months]
Measuring by microFET 2
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
women with gynecological cancer surgery
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aged of 20-75 years
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currently have lower extremity lymphedema.
Exclusion Criteria:
-
heart failure
-
kidney failure
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DVT
-
limb surgery
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Cheng Kung University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A-ER-107-433