LymphedemaNCT05239273
Effects of Complex Decongestive Therapy Applied on Patients With Lower Extremity Lymphedema
A study testing Complex Decongestive Therapy in people with Lymphedema, run by Ankara Yildirim Beyazıt University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Complex Decongestive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between the ages of 18-65
- Having unilateral lymphedema in the lower extremity
- Volunteer to participate in the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Lymphedema
- Being tested
- Complex Decongestive Therapy, Control
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive TherapyOther
Phase 1 of CDT will be applied. This application consists of manual lymph drainage, skin care, compression bandage and exercises.
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Complex Decongestive Therapy (CDT) Group | Experimental | 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. Receives: Other: Complex Decongestive Therapy |
| Control group | Other | Waiting list will included in control group. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 3 weeks
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: change from baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239273
- Sponsor's protocol ID
- 2022/02/05
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05239273
- Acronym / sponsor ID
- 2022/02/05
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Decongestive Therapy (CDT) Group | Experimental | Other: Complex Decongestive TherapyPhase 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 | Other | Other: ControlWaiting list will included in control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be between the ages of 18-65
- Having unilateral lymphedema in the lower extremity
- Volunteer to participate in the study
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Decongestive TherapyPhase 1 of CDT will be applied. This application consists of manual lymph drainage, skin care, compression bandage and exercises. | Other | Complex Decongestive Therapy (CDT) Group |
| ControlNo intervention | Other | Control group |
Primary outcome
Body Awareness
Time frame: change from baseline at 3 weeks
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.
3 secondary outcomes
Lower Extremity Functionality
Time frame: change from baseline at 3 weeks
Life quality
Time frame: change from baseline at 3 weeks
Edema evaluation
Time frame: change from baseline at 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Therapy in people with Lymphedema, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Awareness (time frame: change from baseline at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.