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

Investigation of the Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema on Body Awareness, Functionality and Quality of Life

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphedema
• Intervention / Treatment: Other: Control; Other: Complex Decongestive Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Complex Decongestive Therapy (CDT) Group; 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.	Other: Complex Decongestive Therapy; Phase 1 of CDT will be applied. This application consists of manual lymph drainage, skin care, compression bandage and exercises.
OTHER: Control group; Waiting list will included in control group.	Other: Control; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline at 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	change from baseline at 3 weeks
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.	change from baseline at 3 weeks
Edema evaluation	Edema evaluation will be made with circumference measurement from the lateral malleolus to the groin at intervals of 4 cm.	change from baseline at 3 weeks

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (ACTUAL): February 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 5, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2022/02/05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No