NCT Number: NCT07319611
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.
Trial opening soon.
Get Notified18 year–65 year
Female
Interventional
Not applicable
Istanbul, 34899, Turkey (Türkiye)
Ecem Avukat, Resident Physician
SUB_INVESTIGATOR
Gökçenur Yalçın, MD, Specialist Physician
CONTACT
Gökçenur Yalçın, Specialist Physician
SUB_INVESTIGATOR
Yeliz Bahar Özdemir, Associate Professor
PRINCIPAL_INVESTIGATOR
Yeliz Bahar Özdemir, MD, Associate Professor
CONTACT
İpek Uyanık, Resident Physician
SUB_INVESTIGATOR
Detailed Description
This is a prospective, single-blind (assessor-blinded), randomized controlled trial conducted at Marmara University Pendik Training and Research Hospital, Department of Physical Medicine and Rehabilitation between November 2025 and November 2026.
The study will include 69 female participants diagnosed with lipedema according to clinical criteria. Participants will be randomly assigned (using www.randomizer.org) into three parallel groups (n=23 per group). Randomization and outcome assessment will be performed by independent evaluators blinded to group allocation.
Interventions
Intermittent Pneumatic Compression (IPC): 15 sessions, 3 times/week, using DoctorLife LX7 Max device at 50 mmHg for 30 minutes per session.
HIIT Group: 30 sessions, 3 times/week for 10 weeks, each lasting 23 minutes (5 min warm-up, 7 one-minute intervals with one-minute rests, and 5 min cool-down). Intensity determined by Graded Cycling Test with Talk Test (GCT-TT).
MICT Group: 30 sessions, 3 times/week for 10 weeks, each lasting 55 minutes (5 min warm-up, 45 min at 50% GCT-TT power, 5 min cool-down).
Home-based Walking Group: Encouraged to walk ≥10,000 steps daily using a validated pedometer app (PACER), supported by motivational follow-up and exercise diaries.
All exercise sessions will be supervised by a physiotherapist, and participants will be continuously monitored for heart rate, rhythm, oxygen saturation, and blood pressure.
Assessments
Measurements will include:
Limb volume (circumferential measurements every 8 cm, truncated cone formula)
6-Minute Walk Test (6MWT) for functional capacity
Isometric quadriceps strength using a hand-held dynamometer
Pressure pain threshold via algometer
VAS, LEFS, SF-12, PSQI, FSS, HADS, and IPAQ-SF questionnaires
Data collection will occur at three time points: baseline (T0), after 15 IPC sessions (T1), and at the end of 10 weeks (T2).
Statistical Plan
Power analysis (f=0.25, α=0.05, power=0.80) determined a total sample size of 57, increased to 69 to account for 20% dropout. Data will be analyzed using repeated measures ANOVA to compare time × group interactions.
Expected Outcomes
The study expects that both HIIT and MICT combined with IPC will significantly reduce limb volume and pain, and improve functional capacity, sleep, fatigue, and quality of life compared to home-based walking with IPC alone.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Applied 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.
Participants perform ≥10,000 steps/day using PACER pedometer app; encouraged through exercise logs and follow-up.
Supervised cycling-based interval exercise, 3×/week for 10 weeks, individualized by GCT-TT protocol.
Supervised continuous cycling exercise, 3×/week for 10 weeks, at 50% GCT-TT power output.
Time frame: Baseline (Day 1), after 15 IPC sessions (Day 36), and post-intervention (Day 71)
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.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
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.
Time frame: Baseline (Day 0), and end of week 10 (Day 71)
The IPAQ-SF assesses physical activity intensity and duration. Higher scores indicate greater activity level.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
The FSS measures the impact of fatigue on daily functioning. Scores ≥36 indicate severe fatigue. Lower post-treatment scores indicate improvement.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
The SF-12 questionnaire evaluates physical and mental components of quality of life. Higher scores represent better health-related quality of life.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
The LEFS assesses lower limb functional abilities. Each item is rated 0-4; total score ranges 0-80, with higher scores indicating better function.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Pressure pain threshold will be measured using a digital algometer on the lateral thigh and dorsum of the hand (reference point). Increased threshold values indicate improved pain tolerance.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Maximal isometric knee extension strength will be measured bilaterally using an electronic hand-held dynamometer at 60° knee flexion. The average of two trials will be recorded. Higher values indicate greater strength.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Pain intensity in both lower limbs will be assessed using a 100-mm Visual Analog Scale (VAS) under three conditions: movement, rest, and night pain. Higher scores indicate greater pain severity. The primary comparison is the change from baseline to week 10.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
The PSQI assesses sleep quality; total score >5 indicates poor sleep. Lower scores represent better sleep quality.
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
HADS includes anxiety (HADS-A) and depression (HADS-D) subscales, each ranging from 0-21. Higher scores reflect more severe symptoms. Lower scores post-intervention indicate improvement.
Time frame: Throughout the 10-week intervention period; summarized at post-intervention (Day 71)
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.
Time frame: Throughout the 10-week intervention period; summarized at post-intervention (Day 71)
Monitoring of adverse events during IPC or exercise sessions, including vital signs (heart rate, rhythm, oxygen saturation, and blood pressure) recorded each session.
Contact information is provided by the study sponsor or research team.
Gökçenur Yalçın, MD, Specialist Physician
CONTACT
Yeliz BAHAR ÖZDEMİR, MD, Associate Professor
CONTACT
Marmara University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07683559
Connective Tissue Diseases, Lipedema
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07667270
Behavior, Connective Tissue Diseases
Balıkesir, Turkey (Türkiye)
View Trial DetailsNCT07651813
Connective Tissue Diseases, Lipedema
View Trial DetailsNCT07240415
Chronic Pain, Connective Tissue Diseases
View Trial Details