LymphedemaNCT06220903
The Effect of Complex Decongestive Therapy in Patients With Lymphedema
A study testing Complex Decongestive Therapy in people with Lymphedema and Urine Marking, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate objectively the effect of lymphatic fluid which is circulated with Complex Decongestive Therapy on fluid excretion from the body in patients with lymphedema. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Lymphedema, Urine Marking, Quality of Life
- What is being tested?
- Complex Decongestive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 30 Jun 2019
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female cases
- Cases diagnosed with lower extremity unilateral/bilateral lymphedema
- Having received or not received radiotherapy and/or chemotherapy
Who cannot join
- Having received treatment for lymphedema in the last year
- Having metastatic disease
- Those diagnosed with severe heart failure and/or arrhythmia
- Arterial disorders
- Kidney diseases
- Infection in affected extremities
Show all 13Show fewer
- Psychological disorders
- Diabetes
- Nephrotic syndrome
- Diuretic use
- Patients using chemotherapy and drugs that have toxic effects on the kidneys
- Those with liver cirrhosis, liver disease
- Neurological diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34100
About this study
Official title: The Effect of Complex Decongestive Therapy on Fluid Excretion From The Body in Patients With Lymphedema
The aim of this study is to investigate objectively the effect of lymphatic fluid which is circulated with Complex Decongestive Therapy on fluid excretion from the body in patients with lymphedema.
Read the detailed description
The lymphatic system is the accessory circulatory system that takes lymph fluid from the interstitial space and adds it to the blood circulation. It starts from the interstitial space. It consists of lymph vessels, lymph fluid and lymphatic organs. Lymph fluid passes through many lymph nodes during its transport and is filtered in these nodules. The lymphatic system takes lymphatic fluid from the tissues and brings it to the venous part of the circulatory system. The main task of the lymph system is to reabsorb substances that cannot be absorbed by the blood circulation system. Non-absorbable substances in the interstitial space are called lymphatic load. Lymphatic load; It consists of protein, water, fat and cells. The aim of lymphedema treatment is to remove the protein-rich fluid accumulated in the interstitial space into the venous system. There are many factors in the flow of lymph fluid into the veins. The most important of these is the high filtration pressure that occurs when fluid is filtered through blood capillaries. Lymph fluid flowing from the periphery to the center is generally affected by pressure changes and moves from where the pressure is high to where it is low. Contraction of the muscles adjacent to the lymph vessels, pulsation of the neighboring arteries, and the effect of the smooth muscles in the lymph vessel wall also cause pressure changes. Other factors include respiratory movements acting as a pump in the lymph flow, the actual pressure effect of abdominal pressure on the cisterna chyli, and negative intrathoracic pressure.
Complex Decongestive Physiotherapy is proven effective and considered the gold standard for the treatment of lymphedema. It increases the hydrostatic pressure that has decreased due to edema and helps the lymph fluid to re-enter the circulation.
Purpose of the study; To objectively investigate whether the lymph fluid added to the circulation through Complex Decongestive Physiotherapy in lymphedema patients has an effect on fluid excretion from the body.
- Conditions
- Lymphedema, Urine Marking, Quality of Life, Edema
- Being tested
- Complex Decongestive Therapy
- Medical subject headings
- Lymphedema, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive TherapyOther
- Manual Lymph Drainage: Cervical region lymph drainage and abdominal region lymph drainage (especially combined with abdominal breathing) were applied.
- Skin Care: Moisturizing creams with a pH of 5.5 were applied to the extremities before bandaging.
- Multilayer Bandaging: Short pull bandage application was applied in a gradient manner.
- Exercise: Joint range of motion exercises, breathing exercises (abdominal breathing), decongestive exercises, and self-drainage techniques were taught.
- Compression Stocking: After the decongestion phase was over, flat knit compression stockings were recommended according to the patient's extremity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Complex DecongestivePhysiotherapy program was planned for the affected extremity of the cases. The treatment was performed 5 days a week, for 4 weeks, for a total of 20 sessions and each session was 60 minutes. The treatment included Manual Lymph Drainage, skin care, multi-layer bandaging, exercise and compression stockings. Receives: Other: Complex Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MoistureMeterD Compact Device
Tissue dielectric constant technique provides information about the emergence of lymphedema in the early stages and the change in the amount of water under the skin. A high-frequency electromagnetic wave produced by the device is directed to the skin by contacting the probe with the skin. The effective measurement depth is 2.5 mm. The device evaluates the amount of water under the tissue thought to be the beginning of lymphedema.
Measured: 4 weeks
Liquid Intake-Urine Excretion Tracking
The subjects were asked to fill out a 24-hour fluid intake-urine excretion chart to evaluate the difference between fluid intake and urine excretion.
Measured: 4 weeks
Secondary outcomes (4)
Body Mass Index
BMI values of the cases; Calculated and recorded using TANITA MC 780 S Professional Body Analysis Monitor. It was calculated with the formula Body Mass Index (BMI) = Weight/Height2 (kg/m2).
Measured: 4 weeks
Range of motion
Universal Goniometer was used to evaluate joint range of motion. Hip, knee and foot flexion were measured.
Measured: 4 weeks
Evaluation of edema
While the patients were in a semi-sitting position and the foot and ankle were in neutral position, circumference measurements were made with a tape measure at 5 cm intervals from the ankle to the lateral malleolus level towards the proximal. Extremity volume was determined by calculating with the frustum formula. The difference between both extremities (healthy and diseased side) was determined and measurements were made every day before and during treatment.
Measured: 4 weeks
Lymphedema Quality of Life
The patients' quality of life was evaluated using the Lymphedema Quality of Life Questionnaire-Lower extremity, which consists of questions about symptoms, body image, function and mode, respectively.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Sep 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 Medipol 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
- Not applicable
- Intervention model
- Single group
- Model description
- A study group that received treatment and was monitored for a total of 20 sessions every day.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilanur Özkaraoğlu, PT, MSc, Medipol University
- Investigators
- Cemile Uydur, MsC, Principal investigator, Avrupa Şafak Hospital Physical Therapy and Rehabilitation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220903
- Sponsor's protocol ID
- MedipolU-FTR-DO-02
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Complex Decongestive Therapy on Fluid Excretion From The Body in Patients With Lymphedema
- ClinicalTrials.gov ID
- NCT06220903
- Acronym / sponsor ID
- MedipolU-FTR-DO-02
- Conditions
- Lymphedema, Urine Marking, Quality of Life, Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 24 Jan 2024 (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 objectively the effect of lymphatic fluid which is circulated with Complex Decongestive Therapy on fluid excretion from the body in patients with lymphedema.
Detailed description
The lymphatic system is the accessory circulatory system that takes lymph fluid from the interstitial space and adds it to the blood circulation. It starts from the interstitial space. It consists of lymph vessels, lymph fluid and lymphatic organs. Lymph fluid passes through many lymph nodes during its transport and is filtered in these nodules. The lymphatic system takes lymphatic fluid from the tissues and brings it to the venous part of the circulatory system. The main task of the lymph system is to reabsorb substances that cannot be absorbed by the blood circulation system. Non-absorbable substances in the interstitial space are called lymphatic load. Lymphatic load; It consists of protein, water, fat and cells. The aim of lymphedema treatment is to remove the protein-rich fluid accumulated in the interstitial space into the venous system. There are many factors in the flow of lymph fluid into the veins. The most important of these is the high filtration pressure that occurs when fluid is filtered through blood capillaries. Lymph fluid flowing from the periphery to the center is generally affected by pressure changes and moves from where the pressure is high to where it is low. Contraction of the muscles adjacent to the lymph vessels, pulsation of the neighboring arteries, and the effect of the smooth muscles in the lymph vessel wall also cause pressure changes. Other factors include respiratory movements acting as a pump in the lymph flow, the actual pressure effect of abdominal pressure on the cisterna chyli, and negative intrathoracic pressure.
Complex Decongestive Physiotherapy is proven effective and considered the gold standard for the treatment of lymphedema. It increases the hydrostatic pressure that has decreased due to edema and helps the lymph fluid to re-enter the circulation.
Purpose of the study; To objectively investigate whether the lymph fluid added to the circulation through Complex Decongestive Physiotherapy in lymphedema patients has an effect on fluid excretion from the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A study group that received treatment and was monitored for a total of 20 sessions every day.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Complex Decongestive TherapyComplex DecongestivePhysiotherapy program was planned for the affected extremity of the cases. The treatment was performed 5 days a week, for 4 weeks, for a total of 20 sessions and each session was 60 minutes. The treatment included Manual Lymph Drainage, skin care, multi-layer bandaging, exercise and compression stockings. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female cases
- Cases diagnosed with lower extremity unilateral/bilateral lymphedema
- Having received or not received radiotherapy and/or chemotherapy
Key exclusion criteria (13 listed)
- Having received treatment for lymphedema in the last year
- Having metastatic disease
- Those diagnosed with severe heart failure and/or arrhythmia
- Arterial disorders
- Kidney diseases
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 Therapy1. Manual Lymph Drainage: Cervical region lymph drainage and abdominal region lymph drainage (especially combined with abdominal breathing) were applied. 2. Skin Care: Moisturizing creams with a pH of 5.5 were applied to the extremities before bandaging. 3. Multilayer Bandaging: Short pull bandage application was applied in a gradient manner. 4. Exercise: Joint range of motion exercises, breathing exercises (abdominal breathing), decongestive exercises, and self-drainage techniques were taught. 5. Compression Stocking: After the decongestion phase was over, flat knit compression stockings were recommended according to the patient's extremity. | Other | Treatment Group |
Primary outcome
MoistureMeterD Compact Device
Time frame: 4 weeks
Tissue dielectric constant technique provides information about the emergence of lymphedema in the early stages and the change in the amount of water under the skin. A high-frequency electromagnetic wave produced by the device is directed to the skin by contacting the probe with the skin. The effective measurement depth is 2.5 mm. The device evaluates the amount of water under the tissue thought to be the beginning of lymphedema.
Liquid Intake-Urine Excretion Tracking
Time frame: 4 weeks
The subjects were asked to fill out a 24-hour fluid intake-urine excretion chart to evaluate the difference between fluid intake and urine excretion.
4 secondary outcomes
Body Mass Index
Time frame: 4 weeks
Range of motion
Time frame: 4 weeks
Evaluation of edema
Time frame: 4 weeks
Lymphedema Quality of Life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
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The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
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.
Cemile Uydur, MsC principal investigator
Avrupa Şafak Hospital Physical Therapy and Rehabilitation Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Therapy in people with Lymphedema and Urine Marking, run by Medipol University at 1 site in Turkey (Türkiye).
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 13 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: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MoistureMeterD Compact Device (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 25 Jan 2024.