LipedemaNCT07319611
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
A study testing Intermittent Pneumatic Compression (IPC), Home-Based Walking Program and High-Intensity Interval Training (HIIT) in people with Lipedema and Exercise Therapy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema, Exercise Therapy, High Intensity Interval Training
- What is being tested?
- Intermittent Pneumatic Compression (IPC), Home-Based Walking Program and High-Intensity Interval Training (HIIT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18-65 years
- Able to read and write (literate)
- Clinically diagnosed with lipedema according to Halk and Damstra criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Istanbul, 34899
Yeliz Bahar Özdemir, MD, Associate Professor, +90 216 625 45 45, yeliz.ozdemir@marmara.edu.tr
Gökçenur Yalçın, MD, Specialist Physician, +90 216 625 45 45, gokcenur.yalcin@marmara.edu.tr
About this study
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.
Read more
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.
Read the 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
- Being tested
- Intermittent Pneumatic Compression (IPC), Home-Based Walking Program, High-Intensity Interval Training (HIIT), Moderate-Intensity Continuous Training (MICT)
- Keywords
- lipedema, high intensity interval training, moderate intensity continuous training
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Home-Based Walking ProgramBehavioural
Participants perform ≥10,000 steps/day using PACER pedometer app; encouraged through exercise logs and follow-up.
High-Intensity Interval Training (HIIT)Behavioural
Supervised cycling-based interval exercise, 3×/week for 10 weeks, individualized by GCT-TT protocol.
Moderate-Intensity Continuous Training (MICT)Behavioural
Supervised continuous cycling exercise, 3×/week for 10 weeks, at 50% GCT-TT power output.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Intermittent Pneumatic Compression (IPC); Behavioral: Moderate-Intensity Continuous Training (MICT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
The IPAQ-SF assesses physical activity intensity and duration. Higher scores indicate greater activity level.
Measured: Baseline (Day 0), and end of week 10 (Day 71)
Change in Fatigue Severity (Fatigue Severity Scale, FSS; 9-63)
The FSS measures the impact of fatigue on daily functioning. Scores ≥36 indicate severe fatigue. Lower post-treatment scores indicate improvement.
Measured: 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)
The SF-12 questionnaire evaluates physical and mental components of quality of life. Higher scores represent better health-related quality of life.
Measured: 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)
The LEFS assesses lower limb functional abilities. Each item is rated 0-4; total score ranges 0-80, with higher scores indicating better function.
Measured: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Change in Pressure Pain Threshold (kg/cm²)
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.
Measured: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Change in Isometric Quadriceps Strength (kgf)
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.
Measured: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Change in Pain Intensity (VAS; 0-100 mm)
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.
Measured: 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)
The PSQI assesses sleep quality; total score >5 indicates poor sleep. Lower scores represent better sleep quality.
Measured: 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)
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.
Measured: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start25 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeliz BAHAR ÖZDEMİR, Associate Professor, Study director, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319611
- Sponsor's protocol ID
- MarmaraU-FTR-GNY-01
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study, including demographic characteristics, outcome measures (e.g., limb volume, 6-minute walk distance, pain scores), and adverse event data, will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07319611
- Acronym / sponsor ID
- MarmaraU-FTR-GNY-01
- Conditions
- Lipedema, Exercise Therapy, High Intensity Interval Training
- Keywords
- lipedema, high intensity interval training, moderate intensity continuous training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent Pneumatic Compression + Home-Based Walking Program | Experimental | Device: Intermittent Pneumatic Compression (IPC), Behavioral: Home-Based Walking ProgramParticipants 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. |
| Intermittent Pneumatic Compression + High-Intensity Interval Training (HIIT) | Experimental | Device: Intermittent Pneumatic Compression (IPC), Behavioral: 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. |
| Intermittent Pneumatic Compression + Moderate-Intensity Continuous Training (MICT) | Experimental | Device: Intermittent Pneumatic Compression (IPC), Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female participants aged 18-65 years
- Able to read and write (literate)
- Clinically diagnosed with lipedema according to Halk and Damstra criteria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | 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 ProgramParticipants perform ≥10,000 steps/day using PACER pedometer app; encouraged through exercise logs and follow-up. | Behavioural | Intermittent Pneumatic Compression + Home-Based Walking Program |
| High-Intensity Interval Training (HIIT)Supervised cycling-based interval exercise, 3×/week for 10 weeks, individualized by GCT-TT protocol. | Behavioural | Intermittent Pneumatic Compression + High-Intensity Interval Training (HIIT) |
| Moderate-Intensity Continuous Training (MICT)Supervised continuous cycling exercise, 3×/week for 10 weeks, at 50% GCT-TT power output. | Behavioural | Intermittent Pneumatic Compression + Moderate-Intensity Continuous Training (MICT) |
Primary outcome
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.
10 secondary outcomes
Change in Functional Exercise Capacity (6-Minute Walk Test Distance, meters)
Time frame: 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)
Time frame: Baseline (Day 0), and end of week 10 (Day 71)
Change in Fatigue Severity (Fatigue Severity Scale, FSS; 9-63)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Change in Pressure Pain Threshold (kg/cm²)
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Change in Isometric Quadriceps Strength (kgf)
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Change in Pain Intensity (VAS; 0-100 mm)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (Day 0), end of week 5 (Day 36), and end of week 10 (Day 71)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study, including demographic characteristics, outcome measures (e.g., limb volume, 6-minute walk distance, pain scores), and adverse event data, will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yeliz BAHAR ÖZDEMİR, Associate Professor study director
Marmara University Pendik Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Pneumatic Compression (IPC), Home-Based Walking Program and High-Intensity Interval Training (HIIT) in people with Lipedema and Exercise Therapy, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeliz BAHAR ÖZDEMİR, MD, Associate Professor (+90 216 625 45 45, yeliz.ozdemir@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Extremity Volume (mL) (time frame: Baseline (Day 1), after 15 IPC sessions (Day 36), and post-intervention (Day 71)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.