Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema

NCT06839885 | Recruiting

• 1 other identifier: GaziosmanpasaTREH-FTR-ÇA-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Lower Limb Lymphedema; Unilateral Leg Edema

Keywords

Aerobic exercise; Hydrotherapy; Functionality; Gynecological cancer; Lymphedema; Exercise capacity; Quality of life

Outcome Measures

Primary Outcomes (1)

• Volume measurement

  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.

  six weeks

Secondary Outcomes (2)

• Lymphedema Quality of Life Questionnaire-Leg( LYMQOL-Leg)

  six weeks

• Lower Extremity Functional Scale

  six weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Other: Control group

Intervention Group

EXPERIMENTAL

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.

Other: Interventional group

Interventions

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.

Intervention Group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

GaziosmanpasaTREH

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 33849087 BACKGROUND

• 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.

  PMID: 30247973 BACKGROUND

• 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.

  PMID: 28346851 BACKGROUND

MeSH Terms

Conditions

Lymphedema

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ebru Yılmaz Yalçınkaya

  Gaziosmanpasa Research and Education Hospital

  STUDY DIRECTOR

Central Study Contacts

Kevser Gümüşsu

CONTACT

05323628768; kevsergumussu@hotmail.com

Çiğdem Aşlı

CONTACT

05433712755; drcigdemasli7974@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: two groups: an intervention group and a control group

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: December 15, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)