Effects of Aquatic and Land-Based Exercise on Functional, Clinical, and Lymphatic Outcomes in Women With Lipedema: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Functional capacity measured by Six-Minute Walk Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: aquatic therapy (Other)
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.
干预措施: 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.
干预措施: usual care (Other)
结局指标
主要结局
Functional capacity measured by Six-Minute Walk Test
时间窗: 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.
次要结局
- Symptom-Related Outcomes(12 weeks)
- Body Mass Index(12 weeks)
- Waist-to-Height Ratio(12 weeks)
- Three-Dimensional Lower-Limb Scanning(12 weeks)
- Health-Related Quality of Life(12 weeks)
- Segmental Bioimpedance Spectroscopy(12 weeks)
研究者
Ebtesam Nabil
Assistant professor at Physical Therapy Department for Cardiovascular/Respiratory Disorder and Geriartics
Cairo University