LipedemaNCT07756463
Aquatic Versus Land-Based Exercise in Women With Lipedema
A study testing aquatic therapy and land- based exercise in people with Lipedema, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- aquatic therapy and land- based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effects of Aquatic and Land-Based Exercise on Functional, Clinical, and Lymphatic Outcomes in Women With Lipedema: A Randomized Controlled Trial
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.
- Conditions
- Lipedema
- Being tested
- aquatic therapy, land- based exercise, usual care
- Keywords
- lipedema, hydrotherapy, therapeutic exercise, six-minute walk test, symptom burden, quality of life
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Aquatic therapy group | Experimental | 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. Receives: Other: aquatic therapy |
| land-based exercise group | Active comparator | 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. Receives: Other: land- based exercise |
| control group | Other | Participants will receive manual lymphatic drainage, intermittent pneumatic compression, a weight-reduction diet, and a compression garment will be provided by the research team. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start27 Aug 2026 (estimated)
- Primary completion2 Sep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Nabil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756463
- Sponsor's protocol ID
- P.T.REC/012/006541
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic and Land-Based Exercise on Functional, Clinical, and Lymphatic Outcomes in Women With Lipedema: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07756463
- Acronym / sponsor ID
- P.T.REC/012/006541
- Conditions
- Lipedema
- Keywords
- lipedema, hydrotherapy, therapeutic exercise, six-minute walk test, symptom burden, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Aug 2026 (estimated)
- Primary completion
- 2 Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aquatic therapy group | Experimental | Other: aquatic therapySupervised 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. |
| land-based exercise group | Active comparator | Other: land- based exerciseThe 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. |
| control group | Other | Other: usual careParticipants will receive manual lymphatic drainage, intermittent pneumatic compression, a weight-reduction diet, and a compression garment will be provided by the research team. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aquatic therapyHydotherapy 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. | Other | Aquatic therapy group |
| land- based exerciseSessions 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. | Other | land-based exercise group |
| usual careParticipants 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 | Other | control group |
Primary outcome
Functional capacity measured by Six-Minute Walk Test
Time frame: 12 weeks
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.
6 secondary outcomes
Body Mass Index
Time frame: 12 weeks
Waist-to-Height Ratio
Time frame: 12 weeks
Three-Dimensional Lower-Limb Scanning
Time frame: 12 weeks
Symptom-Related Outcomes
Time frame: 12 weeks
Health-Related Quality of Life
Time frame: 12 weeks
Segmental Bioimpedance Spectroscopy
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aquatic therapy and land- based exercise in people with Lipedema, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity measured by Six-Minute Walk Test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.