Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema

Not Applicable

Recruiting

• Conditions: Lower Limb Lymphedema; Unilateral Leg Edema

• Registration Number: NCT06839885
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

Lymphedema is a chronic condition that negatively affects patients' quality of life and lower extremity functions, causing swelling and a feeling of heaviness in the extremity, as well as posing an economic burden. The gold standard in lymphedema treatment is complex decongestive therapy.Manual lymphatic drainage, skin care, the use of compression garments, and home exercise programs play an important role. Exercise therapies lead to a reduction in volume and an improvement in functionality and quality of life in patients with lymphedema. However, studies on this subject have mostly focused on upper extremity lymphedema. This study aims to compare the effects of a home exercise program and hydrotherapy combined with a home exercise program on quality of life, lower extremity functionality, exercise capacity, and edema severity in patients with unilateral lower extremity lymphedema

Detailed Description

This study included patients, with in the control group and in the intervention group, who applied to the lymphedema outpatient clinic at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Therapy and Rehabilitation. The demographic and clinical data of the patients were recorded. Before treatment, limb volume was assessed using the circumference measurement method, quality of life was evaluated with the Lymphedema Quality of Life Questionnaire (LYMQOL), lower extremity functionality was assessed with the Lower Extremity Functional Scale (LEFS), and exercise capacity was measured using the 10-Meter Walk Test. Patients in the control group followed only a home exercise program for 6 weeks, while the intervention group received hydrotherapy combined with a home exercise program for the same period. Hydrotherapy was conducted as 30-minute aquatic exercise sessions in groups of 5-7 participants, in a hydrotherapy pool with a depth of 130 cm and a temperature of 30-31°C, under the supervision of a trained physiotherapist. At the end of the treatment, patients were re-evaluated in terms of volume, functionality, quality of life, and exercise capacity. The two groups were compared regarding volume measurement, functionality, and quality of life

Study Timeline

• Study Start: 2024-12-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-09-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients with primary or secondary unilateral lower extremity lymphedema diagnosis
• Patients who have received at least 2 weeks of complex decongestive therapy in the past
• Patients who are cooperative with hydrotherapy treatments
• Patients who are willing to participate in the treatment
• Patients aged 18-75

Exclusion Criteria

• Patients who are unable to perform the evaluation parameters
• Patients with serious systemic diseases that may prevent exercise
• Patients who have had an injury and/or surgery in the last 6 months
• Conditions where hydrotherapy is contraindicated (severe fear of water, behavioral problems, shortness of breath at rest, incontinence, known chlorine allergy, open wound, acute systemic illness, epilepsy, tracheostomy, permanent drain, immunodeficiency)
• Patients with an active infection anywhere in the body
• Patients who have undergone sentinel lymph node biopsy
• Patients with active metastatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Volume measurement	six weeks	Patients who applied to the lymphedema outpatient clinic had their leg circumference measurements taken before starting the treatment program and 6 weeks later, starting from the ankle (medial malleolus) and at 4 cm intervals up to the inguinal region. Using these measured data, an approximate volume calculation was made using the circumference (Frustum) method.

Secondary Outcome Measures

Name	Time	Method
Lymphedema Quality of Life Questionnaire-Leg( LYMQOL-Leg)	six weeks	The LYMQOL-leg questionnaire was used to assess the quality of life specific to lymphedema before and after treatment for all patients participating in the study. The questionnaires were administered through face-to-face interviews.; LYMQOL can be used in clinical assessments for patients with lymphedema, as well as in evaluating treatment outcomes. LYMQOL is a disease-specific quality of life scale for lymphedema patients. The LYMQOL questionnaire has two separate sections for evaluating the upper and lower extremities: LYMQOL-arm and LYMQOL-leg. The questions in the LYMQOL-leg questionnaire are related to 4 sections. This questionnaire consists of a total of 22 questions. Questions 1-3 assess function, questions 4-10 assess body image, questions 11-15 assess symptoms, questions 16-21 assess mood, and question 22 evaluates 'general quality of life.' The first 21 questions are scored on a scale of 1-4 (1 = none, 2 = a little, 3 = quite a bit, 4 = very much).
Lower Extremity Functional Scale	six weeks	The LEFS scale was used to assess the functional status of the lower extremities before and after treatment for all patients participating in the study. The questionnaires were administered through face-to-face interviews. The LEFS questionnaire, used to assess functional status in patients and consists of a total of 20 questions. Each question in the LEFS questionnaire is scored on a scale of 0 to 4 (0 - Extremely difficult or unable to do, 1 - Quite difficult, 2 - Moderately difficult, 3 - Slightly difficult, 4 - No difficulty). The total score ranges from 0 to 80. In the LEFS questionnaire, an increase in the score indicates an improvement in the patient's functional status. The Turkish reliability and validity of this questionnaire have been demonstrated in studies.

Trial Locations

Locations (1)

GaziosmanpasaTREH; 🇹🇷 Istanbul, Turkey