ClinicalTrials.gg
RecruitingNCT07756463Updated Oct 27, 2026

Aquatic Versus Land-Based Exercise in Women With Lipedema

An interventional study of aquatic therapy and land- based exercise in Lipedema, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 27, 2026Now RecruitingFirst site in Egypt+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Lipedema

Browse trials for

Keywords

  • lipedema
  • hydrotherapy
  • therapeutic exercise
  • six-minute walk test
  • symptom burden
  • quality of life
03

In context

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's planned enrollment of 60 is above the median of 35 across 42 interventional studies indexed under Lipedema.

Browse Lipedema studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women diagnosed with lipedema for at least five years
  • Had stage 2 or 3 and type 2 or 3 disease
  • Had a 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 .

Exclusion criteria

Exclusion Criteria:

  • Had 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Aquatic therapy group

    Supervised 12- week water-based exercise program. Each aquatic session consists of four standardized phases. The first five minutes include supported standing, diaphragmatic breathing, and lateral-costal expansion. The subsequent eight-minute warm-up includes forward, backward, and lateral water walking; ankle dorsiflexion and plantarflexion; heel raises; gentle knee flexion; marching; and controlled hip movement. The 25-minute main phase comprises brisk water walking, marching, hip abduction and extension, hamstring curls, supported mini-squats, step-touch movements, calf raises, controlled leg circles, and upper-limb sweeping movements coordinated with breathing. The final seven-minute cool-down includes progressively slower water walking, ankle pumps, and gentle stretching of the gastrocnemius-soleus complex, hamstrings, quadriceps, and hip flexors.

    Other: aquatic therapy

  • Active comparator
    land-based exercise group

    The land-based 12- week program combined low-impact aerobic training, lower-limb strengthening, muscle-pump exercises, flexibility training, postural control, and breathing exercises. Each session will begin with an eight-minute warm-up consisting of diaphragmatic breathing, ankle dorsiflexion and plantarflexion, heel and toe raises, slow marching, gentle trunk rotation, and low-intensity walking. The aerobic phase will last approximately 12 minutes and consist of walking on level ground or on a treadmill. The 18-minute strengthening phase will include sit-to-stand exercises, supported mini-squats, heel raises, standing hip abduction and extension, knee flexion and extension, low step-ups, supine bridging, and side-lying hip abduction.

    Other: land- based exercise

  • Other
    control group

    Participants will receive manual lymphatic drainage, intermittent pneumatic compression, a weight-reduction diet, and a compression garment will be provided by the research team.

    Other: usual care

Interventions

  • Otheraquatic therapy

    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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. Symptom-Related Outcomes

    Pain 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

    Time frame: 12 weeks

  5. Health-Related Quality of Life

    Health-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.

    Time frame: 12 weeks

  6. Segmental Bioimpedance Spectroscopy

    It 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

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

Of 29 interventional studies with no phase under Lipedema, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 10, 2026
StartActual
Aug 27, 2026
Primary completionEst.
Sep 2, 2027
CompletionEst.
Oct 2027
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 27, 2026
Sites
1 site added — first site in Egypt
Show site
  • Faculty of Physical Therapy · Giza, Egypt
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Egypt
    Show site
    • Faculty of Physical Therapy · Giza, Egypt
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07756463
Lead sponsor
Cairo University
Responsible party
Ebtesam Nabil (Assistant professor at Physical Therapy Department for Cardiovascular/Respiratory Disorder and Geriartics, Cairo University) — Principal investigator
First posted
Aug 10, 2026
Start date
Aug 27, 2026
Primary completion
Sep 2, 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Ebtesam N Nagy
Contact
dr.ebtesamnagy2@outlook.com
0201278141946
Ebtesam N Nagy
Contact
dr.entesamnagy2@outlook.com
0201278141946
Ebtesam N Nagy
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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