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
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedFebruary 14, 2022
February 1, 2022
6 months
February 5, 2022
February 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Lower Extremity Functionality
change from baseline at 3 weeks
Life quality
change from baseline at 3 weeks
Edema evaluation
change from baseline at 3 weeks
Study Arms (2)
Complex Decongestive Therapy (CDT) Group
EXPERIMENTALPhase 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.
Control group
OTHERWaiting list will included in control group.
Interventions
Phase 1 of CDT will be applied. This application consists of manual lymph drainage, skin care, compression bandage and exercises.
Eligibility Criteria
You may qualify if:
- Be between the ages of 18-65
- Having unilateral lymphedema in the lower extremity
- Volunteer to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seyda Toprak Celenay
Ankara Yildirim Beyazıt University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
February 5, 2022
First Posted
February 14, 2022
Study Start
March 1, 2022
Primary Completion
September 1, 2022
Study Completion
March 1, 2023
Last Updated
February 14, 2022
Record last verified: 2022-02