Quality of Life Clinical Trial
Official title:
The Effect of Complex Decongestive Therapy on Fluid Excretion From The Body in Patients With Lymphedema
Verified date | January 2024 |
Source | Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University | Istanbul | Beykoz |
Lead Sponsor | Collaborator |
---|---|
Medipol University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 weeks | |
Primary | 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. | 4 weeks | |
Secondary | 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). | 4 weeks | |
Secondary | Range of motion | Universal Goniometer was used to evaluate joint range of motion. Hip, knee and foot flexion were measured. | 4 weeks | |
Secondary | 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. | 4 weeks | |
Secondary | 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. | 4 weeks |
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