Aquatic Versus Land-Based Exercise in Women With Lipedema

N/ANot Yet RecruitingNCT07756463

Cairo University60 enrolled

Overview

To evaluate optimal workout environments, a 12-week study assigned women with moderate-to-severe lipedema to three distinct protocols: supervised pool workouts, equivalent land-based training, or basic standard monitoring. Researchers tracked walking endurance alongside tissue composition, fluid levels, pain intensity, and general well-being. The trial posited that structured activity beats routine care alone, with water-based exercise potentially offering superior relief due to buoyancy and hydrostatic fluid compression.

Lipedema is a chronic, underrecognized condition primarily affecting women, characterized by a bilateral and symmetrical expansion of subcutaneous fat and connective tissue in the limbs-most commonly the hips, thighs, and lower legs-while sparing the hands and feet. Frequently misdiagnosed as standard obesity, lymphedema, or venous insufficiency due to overlapping symptoms, it lacks a specific biomarker, requiring diagnosis via clinical history, physical exam, and exclusion of differential conditions. Unlike typical obesity, lipedema-related limb enlargement is accompanied by distinct symptoms: Physical Discomfort: Spontaneous or pressure-induced pain, tenderness, persistent heaviness, easy bruising, and nodular or fibrotic tissue changes. Functional Decline: Worsening symptoms from standing or inactivity, leading to reduced quadriceps strength, diminished walking capacity, and functional impairment beyond what is explained by body mass alone. Psychosocial Impact: High rate of emotional distress, poor body image, and reduced quality of life driven by pain, diagnostic delays, and societal stigma. Underlying Mechanisms: Though incompletely understood, proposed factors include adipocyte hypertrophy, tissue fibrosis, microvascular fragility, chronic inflammation, and altered fluid regulation. Because swelling changes do not inherently reflect lymphatic transport, direct imaging is required to verify lymphatic mechanisms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Lipedema

Interventions

aquatic therapyOTHER

Hydotherapy for lipedema. Sessions will be conducted in a therapeutic pool maintained at approximately 28-30°C. Immersion depth will be individualized between the xiphoid process and shoulder level according to participant height, balance, symptom severity, and exercise tolerance.

land- based exerciseOTHER

Sessions will be supervised by a physiotherapist and conducted in an area equipped with supportive chairs, stable handrails, low steps, exercise mats, and light resistance bands. Participants wear comfortable clothing and supportive footwear.

usual careOTHER

Participants will receive a standardized education session at baseline addressing lipedema, skin care, symptom monitoring, avoidance of prolonged immobility, maintenance of habitual daily activity, and clinical warning signs requiring medical review

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women diagnosed with lipedema for at least five years * Had stage 2 or 3 and type 2 or 3 disease * Had a body mass index of ≥25 and \<40 kg/m² * Able to walk independently, with or without their usual assistive device * Had received medical clearance to participate in moderate-intensity aquatic and land-based exercise * Able to understand the study procedures and provide written informed consent. Exclusion Criteria: * Had clinically significant lymphedema, uncontrolled chronic venous insufficiency, acute thrombosis, or another major cause of lower-limb edema * Had open wounds, active skin infection, fever, or another infectious condition incompatible with pool use * Had uncontrolled cardiovascular, metabolic, respiratory, or neurological disorder that could compromise exercise safety; a cardiac pacemaker or congestive heart failure; pregnancy; active cancer or ongoing chemotherapy, immunotherapy, or radiotherapy * Had history of bariatric surgery, recent major surgery, or liposuction; current use of weight-loss medication * Had current participation in structured aquatic or lower-limb exercise exceeding the protocol-defined threshold; or severe fear of water or inability to enter and exit the pool safely.

Outcomes

Primary Outcomes

Functional capacity measured by Six-Minute Walk Test

Participants will complete a seated rest period of at least 10 minutes before testing. The test will be conducted indoors along a straight 30-m corridor. Participants will be instructed to walk as far as possible during six minutes without running. Rest is permitted when necessary, although the timer continues throughout the test. The total distance walked will be recorded in meters. In the Six-Minute Walk Test (6MWT), a greater distance (more meters walked) indicates better functional capacity, superior cardiorespiratory fitness, and greater lower-limb muscular endurance.

Time frame: 12 weeks

Secondary Outcomes

Body Mass Index

Body weight is measured using a calibrated digital scale, and standing height is measured using a wall-mounted stadiometer. Body mass index was calculated as weight in kilograms divided by height in meters squared. Standard World Health Organization adult ranges are: Underweight is below 18.5, Normal weight is 18.5 to 24.9, Overweight is 25 to 29.9, and Obesity is 30 or higher

Time frame: 12 weeks

Waist-to-Height Ratio

Waist circumference is measured using a non-elastic tape at the midpoint between the lowest rib and the iliac crest at the end of normal expiration. The waist-to-height ratio was calculated by dividing waist circumference in centimeters by height in centimeters. Higher values indicate an increased risk of cardiometabolic complications

Time frame: 12 weeks

Three-Dimensional Lower-Limb Scanning

Bilateral lower-limb surface dimensions will be assessed using a three-dimensional optical body scanner. Participants will be scanned barefoot in a standardized upright position with consistent foot placement, lower-limb alignment, clothing, and distance from the scanner.

Time frame: 12 weeks

Symptom-Related Outcomes

Data from ClinicalTrials.gov

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