Health TrialsbyHealthPanel

Manual and Self-Lymphatic Drainage Combined With Exercise in Women With Lipedema

ConditionLipedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorMerve SEVINC GUNDUZ

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female sex.

Aged 18 to 65 years.

Diagnosed with lipedema.

Diagnosed with Stage I, II, III, or IV lipedema.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual Lymphatic Drainage

    Other intervention

    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.

  • Aerobic Exercise

    Other intervention

    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.

  • Self-Lymphatic Drainage

    Other intervention

    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.

  • Physical Activity Guidance

    Other intervention

    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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Manual Lymphatic Drainage + Aerobic ExerciseExperimental treatment 2 interventions
Group B: Self-Lymphatic Drainage + Physical Activity GuidanceActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Pain Intensity

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.

Time frame
Baseline and 6 weeks

Secondary outcomes

1

Health-Related Quality of Life

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.

Time frame
Baseline and 6 weeks
2

Lower Extremity Limb Volume

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.

Time frame
Baseline and 6 weeks
3

Lower Extremity Functional Status

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.

Time frame
Baseline and 6 weeks
4

Functional Mobility

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.

Time frame
Baseline and 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merve SEVINC GUNDUZ

Lead sponsor

Istanbul University - Cerrahpasa

Sponsor institution

Source ClinicalTrials.gov
Apply now