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Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema

Primary Purpose

Lymphedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complex Decongestive Therapy
Control
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be between the ages of 18-65
  • Having unilateral lymphedema in the lower extremity
  • Volunteer to participate in the study

Exclusion Criteria:

  • Having bilateral lower extremity lymphedema
  • Having an active infection
  • Having a mental cognitive disorder
  • Being unable to communicate and cooperate
  • Conditions where manual lymphatic drainage is contraindicated (such as severe heart failure and/or uncontrolled rhythm disturbance, uncontrollable hypertension, being pregnant, presence of thrombus, active infection ect.)
  • Presence of metastases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Complex Decongestive Therapy (CDT) Group

    Control group

    Arm Description

    Phase 1 of CDT will be applied to CDT group. This application consists of manual lymph drainage, skin care, compression bandage and exercises. This phase will continue 5 days a week for 3 weeks.

    Waiting list will included in control group.

    Outcomes

    Primary Outcome Measures

    Body Awareness
    Body Awareness Questionnaire will be used to assess body awareness. This questionnaire was developed by Mallory & Simon and has Turkish validity and reliability. The survey consists of 18 questions. The total score ranges from 18 to 126. As the total score increases, it is concluded that body awareness is good.

    Secondary Outcome Measures

    Lower Extremity Functionality
    Lower extremity functionality will be evaluated with the Lower Extremity Functional Scale. The lower extremity functional scale consists of 20 items and each item is scored between 0-4 and evaluated in 5 items. These are frequently: extreme difficulty/inability to perform the activity, quite difficult, moderate difficulty, a little difficulty and no difficulty. The total score ranges from 0 to 80, and higher scores represent better functional level
    Life quality
    Life quality will be assessed by the Lymphedema Quality of Life Questionnaire. The questionnaire, which consists of 21 questions, consists of the subheadings of Function, Body Image, Symptom, and Emotion. It has a score ranging from 1 to 4 for the first 20 questions. The total score for each area is calculated by adding all the scores and dividing by the total number of questions answered. High scores indicate lower quality of life. The last question about general quality of life is scored between 0 and 10.
    Edema evaluation
    Edema evaluation will be made with circumference measurement from the lateral malleolus to the groin at intervals of 4 cm.

    Full Information

    First Posted
    February 5, 2022
    Last Updated
    February 5, 2022
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05239273
    Brief Title
    Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema
    Official Title
    Investigation of the Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema on Body Awareness, Functionality and Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt 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
    The aim of this study is to investigate the effects of complex decongestive therapy applied to patients with lymphedema in the lower extremities on body awareness, functionality and quality of life.
    Detailed Description
    Lymphedema is a chronic condition characterized by the permanent accumulation of protein-rich fluid in certain body regions as a result of the dysfunction of the lymphatic system, in which skin and subcutaneous changes are added to the picture. Pain in the affected extremity and other accompanying lymphedema symptoms can negatively affect functionality and quality of life, and swelling in the extremity can negatively affect the body image of individuals. Today, Complex Decongestive Therapy (CDT) is accepted as the gold standard in the treatment of lymphedema. It has been shown in the literature that CDT has positive effects on parameters such as functionality, quality of life, and balance in patients with upper limb lymphedema. There are few studies investigating the effects of CDT on body awareness, functionality and quality of life in patients who developed lymphedema in the lower extremities.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphedema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Complex Decongestive Therapy (CDT) Group
    Arm Type
    Experimental
    Arm Description
    Phase 1 of CDT will be applied to CDT group. This application consists of manual lymph drainage, skin care, compression bandage and exercises. This phase will continue 5 days a week for 3 weeks.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Waiting list will included in control group.
    Intervention Type
    Other
    Intervention Name(s)
    Complex Decongestive Therapy
    Intervention Description
    Phase 1 of CDT will be applied. This application consists of manual lymph drainage, skin care, compression bandage and exercises.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    No intervention
    Primary Outcome Measure Information:
    Title
    Body Awareness
    Description
    Body Awareness Questionnaire will be used to assess body awareness. This questionnaire was developed by Mallory & Simon and has Turkish validity and reliability. The survey consists of 18 questions. The total score ranges from 18 to 126. As the total score increases, it is concluded that body awareness is good.
    Time Frame
    change from baseline at 3 weeks
    Secondary Outcome Measure Information:
    Title
    Lower Extremity Functionality
    Description
    Lower extremity functionality will be evaluated with the Lower Extremity Functional Scale. The lower extremity functional scale consists of 20 items and each item is scored between 0-4 and evaluated in 5 items. These are frequently: extreme difficulty/inability to perform the activity, quite difficult, moderate difficulty, a little difficulty and no difficulty. The total score ranges from 0 to 80, and higher scores represent better functional level
    Time Frame
    change from baseline at 3 weeks
    Title
    Life quality
    Description
    Life quality will be assessed by the Lymphedema Quality of Life Questionnaire. The questionnaire, which consists of 21 questions, consists of the subheadings of Function, Body Image, Symptom, and Emotion. It has a score ranging from 1 to 4 for the first 20 questions. The total score for each area is calculated by adding all the scores and dividing by the total number of questions answered. High scores indicate lower quality of life. The last question about general quality of life is scored between 0 and 10.
    Time Frame
    change from baseline at 3 weeks
    Title
    Edema evaluation
    Description
    Edema evaluation will be made with circumference measurement from the lateral malleolus to the groin at intervals of 4 cm.
    Time Frame
    change from baseline at 3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Be between the ages of 18-65 Having unilateral lymphedema in the lower extremity Volunteer to participate in the study Exclusion Criteria: Having bilateral lower extremity lymphedema Having an active infection Having a mental cognitive disorder Being unable to communicate and cooperate Conditions where manual lymphatic drainage is contraindicated (such as severe heart failure and/or uncontrolled rhythm disturbance, uncontrollable hypertension, being pregnant, presence of thrombus, active infection ect.) Presence of metastases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyda Toprak Celenay
    Phone
    +90312 906 1000
    Email
    sydtoprak@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyda Toprak Celenay
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema

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