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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
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    July 26, 2021
    Last Updated
    August 12, 2021
    Sponsor
    National Cheng Kung University
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    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

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

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