Evaluation of the Effects of Hydrotherapy on Lower Extremity Volume, Quality of Life, and Functionality in Patients Diagnosed With Unilateral Lower Extremity Lymphedema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Volume measurement
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The control group will receive a home exercise program, while the intervention group will receive both a home exercise program and hydrotherapy. Outcome assessments will be conducted by an investigator who is blinded to group allocation.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
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.
Intervention: Control group (Other)
Intervention Group
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.
Intervention: Interventional group (Other)
Outcomes
Primary Outcomes
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
- Lymphedema Quality of Life Questionnaire-Leg( LYMQOL-Leg)(six weeks)
- Lower Extremity Functional Scale(six weeks)
Investigators
Çiğdem Aşlı
Medical Doctor
Gaziosmanpasa Research and Education Hospital