This randomized controlled clinical study aims to investigate and compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), when combined with intermittent pneumatic compression (IPC) therapy, on limb volume, functional capacity, pain, fatigue, anxiety, depression, sleep quality, and quality of life in women with lipedema.
Lipedema is a chronic, progressive adipose tissue disorder primarily affecting women, characterized by abnormal and symmetrical fat accumulation in the lower extremities that does not improve with weight loss or limb elevation. It is often misdiagnosed as obesity or lymphedema, leading to delayed treatment. Lipedema causes pain, swelling, bruising, mobility limitation, and reduced quality of life.
Conservative treatment options include compression therapy, manual lymphatic drainage, and exercise. IPC is a non-invasive treatment used to reduce limb volume and pain while improving function and quality of life. Exercise is also a cornerstone of conservative management, but the optimal exercise intensity for lipedema remains unclear.
In this study, 69 female patients aged 18-65 years diagnosed with lipedema according to Halk and Damstra criteria will be randomly assigned into three groups:
IPC + Home-based walking program
IPC + High-Intensity Interval Training (HIIT)
IPC + Moderate-Intensity Continuous Training (MICT)
All participants will receive 15 IPC sessions (3 times per week for 5 weeks). The exercise programs (HIIT or MICT) will continue for 10 weeks, supervised by a physiotherapist. The home-based group will be encouraged to walk ≥10,000 steps daily using a pedometer application.
Primary outcome: Change in limb volume measured by circumferential measurements and the truncated cone formula.
Secondary outcomes: Pain (VAS), functional capacity (6-Minute Walk Test), muscle strength (dynamometry), pressure pain threshold (algometry), physical activity (IPAQ-SF), lower extremity function (LEFS), quality of life (SF-12), sleep quality (PSQI), fatigue (FSS), and anxiety/depression (HADS).
Measurements will be taken at baseline (T0), after 15 IPC sessions (T1), and after 30 total sessions or 10 weeks (T2).
The investigators hypothesize that both HIIT and MICT combined with IPC will provide superior improvements in physical and psychological outcomes compared to IPC with a home-based walking program alone.
Female participants aged 18-65 years
Able to read and write (literate)
Clinically diagnosed with lipedema according to Halk and Damstra criteria
Pregnancy or breastfeeding
Illiteracy
Refusal or inability to provide written/signed consent
Lower extremity fracture, trauma, or surgery within the past 12 months
Parallel
Intermittent Pneumatic Compression (IPC)
DeviceApplied to both lower limbs for 30 minutes at 50 mmHg, 3 times per week for 5 weeks using DoctorLife LX7 Max device. Used in all study arms.
Home-Based Walking Program
BehavioralParticipants perform ≥10,000 steps/day using PACER pedometer app; encouraged through exercise logs and follow-up.
High-Intensity Interval Training (HIIT)
BehavioralSupervised cycling-based interval exercise, 3×/week for 10 weeks, individualized by GCT-TT protocol.
Moderate-Intensity Continuous Training (MICT)
BehavioralSupervised continuous cycling exercise, 3×/week for 10 weeks, at 50% GCT-TT power output.
Change in Lower Extremity Volume (mL)
Lower limb volume will be calculated using circumferential measurements taken every 8 cm along both legs in the standing position. Volumetric values will be derived using the truncated cone formula. The primary endpoint is the change in total limb volume from baseline to week 10. Measurements will be conducted by a blinded assessor.
Change in Functional Exercise Capacity (6-Minute Walk Test Distance, meters)
The 6-Minute Walk Test measures the distance a participant can walk on a flat surface in six minutes. It reflects overall functional capacity and endurance. The change from baseline to week 10 will be compared between groups.
Change in Physical Activity Level (International Physical Activity Questionnaire-Short Form; MET-min/week)
The IPAQ-SF assesses physical activity intensity and duration. Higher scores indicate greater activity level.
Change in Fatigue Severity (Fatigue Severity Scale, FSS; 9-63)
The FSS measures the impact of fatigue on daily functioning. Scores ≥36 indicate severe fatigue. Lower post-treatment scores indicate improvement.
Change in Quality of Life (SF-12 Physical and Mental Composite Scores)
The SF-12 questionnaire evaluates physical and mental components of quality of life. Higher scores represent better health-related quality of life.
Adherence to Exercise and Treatment Program
Measured as the percentage of attended exercise sessions (out of 30 planned) and mean daily step count from pedometer data in the home-based walking group. Used to assess adherence and compliance.
Adverse Events and Cardiovascular Safety
Monitoring of adverse events during IPC or exercise sessions, including vital signs (heart rate, rhythm, oxygen saturation, and blood pressure) recorded each session.
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