The Effect of Complex Decongestive Therapy in Patients With Lymphedema

NCT06220903 | Completed

• 1 other identifier: MedipolU-FTR-DO-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema; Urine Marking; Quality of Life; Edema

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Body Mass Index

  4 weeks

• Range of motion

  4 weeks

• Evaluation of edema

  4 weeks

• Lymphedema Quality of Life

  4 weeks

Study Arms (1)

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.

Other: Complex Decongestive Therapy

Interventions

Complex Decongestive Therapy OTHER

1. 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.

Treatment Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema; Edema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cemile Uydur, MsC

  Avrupa Şafak Hospital Physical Therapy and Rehabilitation Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A study group that received treatment and was monitored for a total of 20 sessions every day.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)