Lipedema
Conditions
Keywords
Manual Lymphatic Drainage, Self-Lymphatic Drainage, Aerobic Exercise, Physical Activity, Pain, Lower Extremity Function, Quality of Life, Limb Volume, Physiotherapy
Brief summary
This randomized controlled study aims to compare the effects of two physiotherapy approaches in women with lipedema. Participants will be assigned to either manual lymphatic drainage combined with supervised aerobic exercise or self-lymphatic drainage combined with physical activity guidance. Both programs will be applied for six weeks. The study will investigate whether these two approaches differ in their effects on pain, lower extremity function, limb volume, mobility, quality of life, and depressive symptoms. Assessments will be performed before the intervention and at the end of the six-week program.
Detailed description
Lipedema is a chronic and progressive adipose tissue disorder that predominantly affects women and is characterized by bilateral and symmetrical disproportionate accumulation of subcutaneous adipose tissue, most commonly in the extremities. Pain, tenderness, swelling, easy bruising, and impaired mobility are common features of the condition and may negatively affect physical function and quality of life. Conservative management of lipedema aims to reduce symptoms, maintain mobility, support lymphatic drainage, and improve quality of life. Exercise, manual lymphatic drainage, self-management strategies, and physical activity are among the conservative approaches used in lipedema management. This randomized controlled study aims to compare the effects of two combined physiotherapy approaches in women with lipedema. A total of 34 women with lipedema are planned to be included. Eligible participants will be allocated to one of two groups: manual lymphatic drainage combined with supervised aerobic exercise or self-lymphatic drainage combined with physical activity guidance. Participants in the manual lymphatic drainage plus aerobic exercise group will receive supervised treatment twice weekly for six weeks. The aerobic exercise program will include warm-up and cool-down periods and treadmill-based aerobic exercise. Exercise intensity will be prescribed at a moderate intensity corresponding to 64-76% of maximum heart rate and will also be monitored using the Borg Rating of Perceived Exertion Scale, with a target rating of 11-13. Manual lymphatic drainage will be administered by a physiotherapist for approximately 30 minutes during each treatment session. Participants in the self-lymphatic drainage plus physical activity group will be instructed by a physiotherapist in self-lymphatic drainage and will receive recommendations for moderate-intensity physical activity. Physical activity intensity will be guided using the Talk Test, with participants encouraged to walk at an intensity at which they can talk but not sing. Participants will be followed throughout the six-week intervention period. Assessments will be performed at baseline and at the end of the six-week intervention. Pain intensity will be assessed using the Visual Analog Scale. Additional assessments will include health-related quality of life using the 36-Item Short Form Health Survey (SF-36), lower extremity functional status using the Lower Extremity Functional Scale, mobility using the Timed Up and Go Test, depressive symptoms using the Beck Depression Inventory, and anthropometric and limb circumference measurements. Limb circumference measurements will also be used to estimate lower extremity volume. The study is designed to determine whether the two combined conservative physiotherapy approaches differ in their effects on pain and other clinical outcomes, including lower extremity function, mobility, limb volume, quality of life, and depressive symptoms, in women with lipedema.
Interventions
OTHERManual Lymphatic Drainage
Manual lymphatic drainage will be administered by a physiotherapist for approximately 30 minutes per session, twice weekly for 6 weeks. Slow, gentle, rhythmic manual techniques will be applied to facilitate lymphatic drainage.
OTHERAerobic Exercise
Participants will perform supervised moderate-intensity treadmill-based aerobic exercise twice weekly for 6 weeks. Exercise intensity will be prescribed at 64-76% of maximum heart rate and monitored using the Borg Rating of Perceived Exertion Scale, targeting a score of 11-13.
OTHERSelf-Lymphatic Drainage
Participants will be instructed by a physiotherapist on how to perform self-lymphatic drainage. They will perform the technique as part of their 6-week intervention program and will be regularly followed by the physiotherapist throughout the intervention period.
Participants will receive guidance from a physiotherapist to engage in moderate-intensity physical activity during the 6-week intervention period. Walking intensity will be guided using the Talk Test, with participants instructed to maintain an intensity at which they can talk but not sing. Participants will be regularly followed throughout the intervention period.
Sponsors
Merve SEVINC GUNDUZ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Group 1: Manual Lymphatic Drainage + Aerobic Exercise Group 2: Self-Lymphatic Drainage + Physical Activity Guidance
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female sex. * Aged 18 to 65 years. * Diagnosed with lipedema. * Diagnosed with Stage I, II, III, or IV lipedema. * No participation in any physiotherapy program within the previous 3 months. * No previous liposuction surgery. * Not currently following a weight-loss diet. * No change in body weight greater than 10% within the previous 6 months. * Willing to participate in the study and provide informed consent.
Exclusion criteria
* Severe visual or cognitive impairment. * Severe cardiovascular disease. * Musculoskeletal conditions or injuries affecting the lower extremities, including osteoarthritis, contracture, or osteoporosis, that may interfere with participation in the study. * Skin conditions that may interfere with the intervention, such as pressure ulcers. * Uncontrolled endocrine disorders, including type 1 or type 2 diabetes mellitus or hypothyroidism. * Obesity secondary to endocrine disorders or medication-induced obesity. * Use of estrogen-progestin therapy within the previous 2 months. * Pregnancy or a positive pregnancy test. * Breastfeeding. * Concurrent participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline and 6 weeks | Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10-cm horizontal line ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst/unbearable pain." Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life | Baseline and 6 weeks | Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. |
| Lower Extremity Limb Volume | Baseline and 6 weeks | Lower extremity circumference measurements will be obtained using a flexible, non-elastic measuring tape at standardized anatomical intervals. Limb volume will be estimated from the circumference measurements using a segmental volume calculation method. The same reference points will be used at baseline and follow-up, with lower calculated volumes indicating lower limb volume. |
| Lower Extremity Functional Status | Baseline and 6 weeks | Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS). The scale consists of 20 items assessing difficulty in performing daily activities. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 80. Higher scores indicate better lower extremity function. |
| Functional Mobility | Baseline and 6 weeks | Functional mobility will be assessed using the Timed Up and Go Test (TUG). Participants will be instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time required to complete the test will be recorded in seconds. A shorter completion time indicates better functional mobility. |
| Depressive Symptoms | Baseline and 6 weeks | Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The questionnaire consists of 21 categories, with each item scored from 0 to 3. The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMerve SEVİNC GUNDUZ, MSc
Outcome results
None listed