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
About this trial
This is an interventional treatment trial for Lymphedema
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
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
NCT ID
NCT05239273
First Posted
February 5, 2022
Last Updated
February 5, 2022
Sponsor
Ankara Yildirim Beyazıt University
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
Learn more about this trial
Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema
We'll reach out to this number within 24 hrs