Gynecological Cancer, Lower Limb Lymphedema
Conditions
Keywords
Women's Health, Home-based Anti-Resistance Exercise
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.
Interventions
BEHAVIORALhome-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.
BEHAVIORALusually care
The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage
Sponsors
National Cheng Kung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactYu-Yun Hsu
Outcome results
None listed