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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Intermittent Pneumatic Compression (IPC)
  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.
• Поведенческое Home-Based Walking Program
  Participants perform ≥10,000 steps/day using PACER pedometer app; encouraged through exercise logs and follow-up.
• Поведенческое High-Intensity Interval Training (HIIT)
  Supervised cycling-based interval exercise, 3×/week for 10 weeks, individualized by GCT-TT protocol.
• Поведенческое Moderate-Intensity Continuous Training (MICT)
  Supervised continuous cycling exercise, 3×/week for 10 weeks, at 50% GCT-TT power output.

Первичные конечные точки

• Change in Lower Extremity Volume (mL) [Срок оценки: Baseline (Day 1), after 15 IPC sessions (Day 36), and post-intervention (Day 71)]

Вторичные конечные точки (10)

• Change in Functional Exercise Capacity (6-Minute Walk Test Distance, meters) [Срок оценки: 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) [Срок оценки: Baseline (Day 0), and end of week 10 (Day 71)]
• Change in Fatigue Severity (Fatigue Severity Scale, FSS; 9-63) [Срок оценки: 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) [Срок оценки: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)]
• Change in Lower Extremity Functional Scale (LEFS; 0-80) [Срок оценки: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)]
• Change in Pressure Pain Threshold (kg/cm²) [Срок оценки: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)]
• Change in Isometric Quadriceps Strength (kgf) [Срок оценки: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)]
• Change in Pain Intensity (VAS; 0-100 mm) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)]

Критерии участия

Критерии включения

• Female participants aged 18-65 years
• Able to read and write (literate)
• Clinically diagnosed with lipedema according to Halk and Damstra criteria

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara University Pendik Training and Research Hospital, Department of Physical Medicine — Istanbul

Идентификаторы

NCT: NCT07319611 · MarmaraU-FTR-GNY-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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