Investigation of the Effects of High-Intensity Interval Exercise and Moderate-Intensity Continuous Exercise on Limb Volume, Functional Capacity, and Quality of Life in Patients With Lipedema
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Marmara University
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Change in Lower Extremity Volume (mL)
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female participants aged 18-65 years
- •Able to read and write (literate)
- •Clinically diagnosed with lipedema according to Halk and Damstra criteria
Exclusion Criteria
- •Pregnancy or breastfeeding
- •Illiteracy
- •Refusal or inability to provide written/signed consent
- •Lower extremity fracture, trauma, or surgery within the past 12 months
- •Cardiopulmonary diseases that contraindicate exercise participation
- •Development of intolerance exercise sessions
Outcomes
Primary Outcomes
Change in Lower Extremity Volume (mL)
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.
Secondary Outcomes
- Change in Fatigue Severity (Fatigue Severity Scale, FSS; 9-63)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Quality of Life (SF-12 Physical and Mental Composite Scores)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Functional Exercise Capacity (6-Minute Walk Test Distance, meters)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Physical Activity Level (International Physical Activity Questionnaire-Short Form; MET-min/week)(Baseline (Day 0), and end of week 10 (Day 71))
- Change in Lower Extremity Functional Scale (LEFS; 0-80)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Sleep Quality (Pittsburgh Sleep Quality Index, PSQI; 0-21)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Pressure Pain Threshold (kg/cm²)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Isometric Quadriceps Strength (kgf)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Pain Intensity (VAS; 0-100 mm)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))
- Change in Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS)(Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71))