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

NCT07319611 | Not Yet Recruiting

• 1 other identifier: MarmaraU-FTR-GNY-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema; Exercise Therapy; High Intensity Interval Training

Keywords

lipedema; high intensity interval training; moderate intensity continuous training

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1), after 15 IPC sessions (Day 36), and post-intervention (Day 71)

Secondary Outcomes (10)

• 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 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 Lower Extremity Functional Scale (LEFS; 0-80)

  Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)

Other Outcomes (2)

• Adherence to Exercise and Treatment Program

  Throughout the 10-week intervention period; summarized at post-intervention (Day 71)

• Adverse Events and Cardiovascular Safety

  Throughout the 10-week intervention period; summarized at post-intervention (Day 71)

Study Arms (3)

Intermittent Pneumatic Compression + Home-Based Walking Program

EXPERIMENTAL

Participants in this group will receive 15 sessions of intermittent pneumatic compression (IPC) therapy combined with a home-based walking program for 10 weeks. IPC will be applied 3 times per week at 50 mmHg pressure for 30 minutes using the DoctorLife LX7 Max device. Participants will also be instructed to walk at least 10,000 steps daily, monitored via a validated pedometer mobile application (PACER). Exercise adherence will be supported through follow-up and exercise diaries.

Device: Intermittent Pneumatic Compression (IPC); Behavioral: Home-Based Walking Program

Intermittent Pneumatic Compression + High-Intensity Interval Training (HIIT)

EXPERIMENTAL

This group will receive 15 sessions of IPC therapy and 30 sessions of supervised high-intensity interval training (HIIT) performed on a stationary cycle ergometer. The program will last 10 weeks (3 sessions per week). Each session will include a 5-minute warm-up, seven 1-minute high-intensity intervals (with 1-minute active recovery periods), and a 5-minute cool-down, for a total of 23 minutes. Exercise intensity will be individually determined using the Graded Cycling Test with Talk Test (GCT-TT), corresponding to Borg scale 14-16 for intervals. Participants will be continuously monitored for heart rate, rhythm, oxygen saturation, and blood pressure during exercise.

Device: Intermittent Pneumatic Compression (IPC); Behavioral: High-Intensity Interval Training (HIIT)

Intermittent Pneumatic Compression + Moderate-Intensity Continuous Training (MICT)

EXPERIMENTAL

This group will receive 15 sessions of IPC therapy and 30 sessions of supervised moderate-intensity continuous training (MICT) over 10 weeks. Each session (55 minutes total) will consist of a 5-minute warm-up, 45 minutes of steady-state cycling at 50% of maximal power output (from the GCT-TT), and a 5-minute cool-down. The corresponding effort equates to Borg scale 12. Sessions will occur 3 times per week under physiotherapist supervision with continuous monitoring of vital signs.

Device: Intermittent Pneumatic Compression (IPC); Behavioral: Moderate-Intensity Continuous Training (MICT)

Interventions

Intermittent Pneumatic Compression (IPC) DEVICE

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.

Intermittent Pneumatic Compression + High-Intensity Interval Training (HIIT); Intermittent Pneumatic Compression + Home-Based Walking Program; Intermittent Pneumatic Compression + Moderate-Intensity Continuous Training (MICT)

Home-Based Walking Program BEHAVIORAL

Participants perform ≥10,000 steps/day using PACER pedometer app; encouraged through exercise logs and follow-up.

Intermittent Pneumatic Compression + Home-Based Walking Program

High-Intensity Interval Training (HIIT) BEHAVIORAL

Supervised cycling-based interval exercise, 3×/week for 10 weeks, individualized by GCT-TT protocol.

Intermittent Pneumatic Compression + High-Intensity Interval Training (HIIT)

Moderate-Intensity Continuous Training (MICT) BEHAVIORAL

Supervised continuous cycling exercise, 3×/week for 10 weeks, at 50% GCT-TT power output.

Intermittent Pneumatic Compression + Moderate-Intensity Continuous Training (MICT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema

Interventions

Intermittent Pneumatic Compression Devices; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yeliz BAHAR ÖZDEMİR, Associate Professor

  Marmara University Pendik Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Yeliz BAHAR ÖZDEMİR, MD, Associate Professor

CONTACT

+90 216 625 45 45; yeliz.ozdemir@marmara.edu.tr

Gökçenur Yalçın, MD, Specialist Physician

CONTACT

+90 216 625 45 45; gokcenur.yalcin@marmara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 6, 2026
• Study Start: December 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available 6 months after publication of the main results and remain accessible for at least 5 years following publication.
• Access Criteria: Qualified researchers may request access to the de-identified dataset and supporting documentation by submitting a brief research proposal and data access agreement to the corresponding investigator (Assoc. Prof. Dr. Yeliz Bahar Ozdemir, Marmara University, Istanbul, Turkey). Data will be shared via a secure institutional data repository upon approval by the principal investigator and the Marmara University Ethics Committee.

Locations

TU (1)