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NCT Number: NCT06839885

Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema

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

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Key information

Conditions

Lower Limb Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Unilateral Leg Edema

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GaziosmanpasaTREH

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Serap Seringeç Karabulut

CONTACT

[email protected]

05057242669

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interventional group

Other

Patients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the last year and completed treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. The patients were planned to be treated in the hydrotherapy unit during lunch breaks, under the supervision of a volunteer physiotherapist.

After the initial assessments, patients in the study group will perform aquatic exercises in groups of 5 or 7 participants, three times a week for 6 weeks, under the supervision of a physiotherapist.Patients in the intervention group will receive a home exercise program and self-drainage.

Control Group

Other

Patients with primary or secondary unilateral lower extremity lymphedema who have received at least 2 weeks of Complex Decongestive Therapy in the past year and completed their treatment at least 3 months ago, and who agreed to participate in the study, were included in the study at Health Sciences University Gaziosmanpasa Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Prior to treatment, all patients were planned to receive education about the treatment to be applied in the form of a home program. Patients were planned to be treated in the hydrotherapy unit during lunch breaks under the supervision of a volunteer physiotherapist.

After the initial assessments, patients in the control group will receive a home exercise program and self-drainage.

Primary outcomes

  1. Volume measurement

    Time frame: 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 outcomes

  1. Lymphedema Quality of Life Questionnaire-Leg( LYMQOL-Leg)

    Time frame: 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).

  2. Lower Extremity Functional Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevser Gümüşsu

CONTACT

[email protected]

05323628768

Çiğdem Aşlı

CONTACT

[email protected]

05433712755

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Evaluation of the Effects of Hydrotherapy on Lower Extremity Volume, Quality of Life, and Functionality in Patients Diagnosed With Unilateral Lower Extremity Lymphedema

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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