Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06839885

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

Led by Gaziosmanpasa Research and Education Hospital · Updated on 2025-02-21

52

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Lymphedema is a long-term condition that causes swelling and heaviness in the lower limbs, affecting quality of life and leg function. This research compares the effects of a home exercise program alone versus hydrotherapy combined with home exercise on quality of life, leg function, exercise capacity, and swelling severity in patients with unilateral lower limb lymphedema. The study includes patients who have completed complex decongestive therapy and aims to improve treatment approaches for this condition. Participants are divided into two groups: one group follows a home exercise program and self-drainage for six weeks, while the other participates in hydrotherapy sessions three times a week along with the home program. Hydrotherapy involves 30-minute aquatic exercises in groups of 5 to 7, led by a trained physiotherapist in a pool with controlled temperature and depth. Both groups receive education on the home program before starting the treatments. Throughout the study, patients undergo assessments before and after treatment, including limb volume measurement, quality of life questionnaires, leg function scales, and a 10-meter walk test. These measurements help researchers evaluate the impact of the treatments on swelling, function, exercise ability, and life quality. The study duration is six weeks, with comparisons made between the two groups based on these outcomes to understand the benefits of adding hydrotherapy.

CONDITIONS

Brief Title

Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 weeks

Participants receive either hydrotherapy combined with a home exercise program or a home exercise program alone to manage unilateral lower extremity lymphedema.

Hydrotherapy group: aquatic exercise sessions 3 times a week; Control group: home exercise program only

Follow-up

Duration - At end of 6-week treatment

Participants are re-evaluated regarding limb volume, quality of life, functionality, and exercise capacity after treatment completion.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

GaziosmanpasaTREH

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

K

Kevser Gümüşsu

Ç

Çiğdem Aşlı

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial.

Khadra Mohamed Ali, Eid Rizk El Gammal, Hadaya Mosaad Eladl

https://pubmed.ncbi.nlm.nih.gov/33849087