NCT07756463

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 27, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2027

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

lipedemahydrotherapytherapeutic exercisesix-minute walk testsymptom burdenquality of life

Outcome Measures

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 continue 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.

    12 weeks

Secondary Outcomes (6)

  • Body Mass Index

    12 weeks

  • Waist-to-Height Ratio

    12 weeks

  • Three-Dimensional Lower-Limb Scanning

    12 weeks

  • Symptom-Related Outcomes

    12 weeks

  • Health-Related Quality of Life

    12 weeks

  • +1 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: usual care

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.

Aquatic therapy group

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

control group

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.

land-based exercise group

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lipedema

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor at Physical Therapy Department for Cardiovascular/Respiratory Disorder and Geriartics

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start (Estimated)

August 27, 2026

Primary Completion (Estimated)

September 2, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08