Clinical trial NCT06220903: The Effect of Complex Decongestive Therapy in Patients With Lymphedema
Official title: The Effect of Complex Decongestive Therapy on Fluid Excretion From The Body in Patients With Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Urine Marking
Quality of Life
Edema
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A study group that received treatment and was monitored for a total of 20 sessions every day.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Female cases
* Cases diagnosed with lower extremity unilateral/bilateral lymphedema
* Having received or not received radiotherapy and/or chemotherapy

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: MoistureMeterD Compact Device
timeFrame: 4 weeks
measure: Liquid Intake-Urine Excretion Tracking
timeFrame: 4 weeks
Secondary outcomes:
measure: Body Mass Index
timeFrame: 4 weeks
measure: Range of motion
timeFrame: 4 weeks
measure: Evaluation of edema
timeFrame: 4 weeks
measure: Lymphedema Quality of Life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Avrupa Şafak Hospital Physical Therapy and Rehabilitation Unit
name: Cemile Uydur, MsC
role: PRINCIPAL_INVESTIGATOR
References: