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Aquatic Versus Land-Based Exercise in Women With Lipedema

Effects of Aquatic and Land-Based Exercise on Functional, Clinical, and Lymphatic Outcomes in Women With Lipedema: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07756463
Enrollment
60
Registered
2026-08-10
Start date
2026-08-27
Completion date
2027-10-01
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipedema

Keywords

lipedema, hydrotherapy, therapeutic exercise, six-minute walk test, symptom burden, quality of life

Brief summary

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.

Detailed description

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.

Interventions

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.

OTHERland- based exercise

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.

OTHERusual care

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional capacity measured by Six-Minute Walk Test12 weeksParticipants 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.

Secondary

MeasureTime frameDescription
Body Mass Index12 weeksBody 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
Waist-to-Height Ratio12 weeksWaist 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
Three-Dimensional Lower-Limb Scanning12 weeksBilateral 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.
Symptom-Related Outcomes12 weeksPain severity, limb heaviness, limb tenderness, and global symptom burden will be evaluated using an 11-point numeric rating scale, where 0 indicates no symptom and 10 indicates the worst imaginable symptom
Health-Related Quality of Life12 weeksHealth-related quality of life will be assessed using the World Health Organization Quality of Life-BREF questionnaire, which comprises 26 items across four domains: physical health, psychological health, social relationships, and environmental health, with higher values indicating better quality of life.
Segmental Bioimpedance Spectroscopy12 weeksIt will be used to estimate extracellular and intracellular fluid in the right and left lower limbs. The principal bioimpedance outcome is bilateral lower-limb extracellular water, expressed in liters. Intracellular water and the extracellular-water-to-total-body-water ratio will be recorded as supportive variables

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026