Clinical trial NCT06839885: Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema
Official title: Evaluation of the Effects of Hydrotherapy on Lower Extremity Volume, Quality of Life, and Functionality in Patients Diagnosed With Unilateral Lower Extremity Lymphedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Lymphedema
Unilateral Leg Edema
Keywords: Aerobic exercise
Hydrotherapy
Functionality
Gynecological cancer
Lymphedema
Exercise capacity
Quality of life
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups: an intervention group and a control group
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Volume measurement
timeFrame: six weeks
Secondary outcomes:
measure: Lymphedema Quality of Life Questionnaire-Leg( LYMQOL-Leg)
timeFrame: six weeks
measure: Lower Extremity Functional Scale
timeFrame: six weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: GaziosmanpasaTREH
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: Ebru Yılmaz Yalçınkaya
role: STUDY_DIRECTOR
References:
citation: Ali KM, El Gammal ER, Eladl HM. Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial. Ann Rehabil Med. 2021 Apr;45(2):131-140. doi: 10.5535/arm.20127. Epub 2021 Apr 14.
citation: Dionne A, Goulet S, Leone M, Comtois AS. Aquatic Exercise Training Outcomes on Functional Capacity, Quality of Life, and Lower Limb Lymphedema: Pilot Study. J Altern Complement Med. 2018 Sep/Oct;24(9-10):1007-1009. doi: 10.1089/acm.2018.0041.
citation: Yeung W, Semciw AI. Aquatic Therapy for People with Lymphedema: A Systematic Review and Meta-analysis. Lymphat Res Biol. 2018 Feb;16(1):9-19. doi: 10.1089/lrb.2016.0056. Epub 2017 Mar 27.