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

NCT ID: NCT07319611

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-25
• Study Completion Date: 2026-07-01

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.

Conditions

Lipedema; Exercise Therapy; High Intensity Interval Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intermittent Pneumatic Compression + Home-Based Walking Program

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.

Group Type: EXPERIMENTAL

Intermittent Pneumatic Compression (IPC)

Intervention Type: 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.

Home-Based Walking Program

Intervention Type: BEHAVIORAL

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

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

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.

Group Type: EXPERIMENTAL

Intermittent Pneumatic Compression (IPC)

Intervention Type: 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.

High-Intensity Interval Training (HIIT)

Intervention Type: BEHAVIORAL

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

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

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.

Group Type: EXPERIMENTAL

Intermittent Pneumatic Compression (IPC)

Intervention Type: 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.

Moderate-Intensity Continuous Training (MICT)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DEVICE

Home-Based Walking Program

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

Intervention Type: BEHAVIORAL

High-Intensity Interval Training (HIIT)

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

Intervention Type: BEHAVIORAL

Moderate-Intensity Continuous Training (MICT)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yeliz BAHAR ÖZDEMİR, Associate Professor

Role: STUDY_DIRECTOR

Marmara University Pendik Training and Research Hospital

Locations

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

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Yeliz BAHAR ÖZDEMİR, MD, Associate Professor

Role: CONTACT

yeliz.ozdemir@marmara.edu.tr

+90 216 625 45 45

Gökçenur Yalçın, MD, Specialist Physician

Role: CONTACT

gokcenur.yalcin@marmara.edu.tr

+90 216 625 45 45

Facility Contacts

Yeliz Bahar Özdemir, MD, Associate Professor

Role: primary

yeliz.ozdemir@marmara.edu.tr

+90 216 625 45 45

Gökçenur Yalçın, MD, Specialist Physician

Role: backup

gokcenur.yalcin@marmara.edu.tr

+90 216 625 45 45

Other Identifiers

MarmaraU-FTR-GNY-01

Identifier Type: -

Identifier Source: org_study_id