Clinical trial NCT05003973: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecological Cancer
Lower Limb Lymphedema
Keywords: Women's Health
Home-based Anti-Resistance Exercise
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Limb circumference change from baseline to 3 months
timeFrame: from baseline to 3 months
measure: Edema change from baseline to 3 months
timeFrame: from baseline to 3 months
measure: Lower limb muscle strength change from baseline to 3 months
timeFrame: from baseline to 3 months
measure: Functional status of lymphatic edema of LLL change from baseline to 3 months
timeFrame: from baseline to 3 months
measure: Fatigue change from baseline to 3 months
timeFrame: from baseline to 3 months
measure: EORTC-QLQ-C30
timeFrame: from baseline to 3 months
Secondary outcomes:
Other outcomes:
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Study officials:
References: