Clinical trial NCT03924999: Comparison of Complete Decongestive Therapy With Intermittent Pneumatic Compression for Treatment of Lipedema
Official title: Comparison of Complete Decongestive Therapy (CDT) With Intermittent Pneumatic Compression (IPK) for Treatment of Lipedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipedema
Keywords: Lipedema
Combined decongestive treatment
Intermittent pneumatic compression
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lipedema is a chronic, progressive and hereditary adipose tissue disorder characterized by an abnormal increase of subcutaneous adipose tissue, especially in the lower extremities. In contrast to obesity, lipoedema may not improve with weight loss and does not include the risk of metabolic syndrome such as diabetes, hypertension and dyslipidemia. However, if not treated for lipedema, medical complications such as hypermobility, joint problems, walking difficulties, and psychological complications such as anxiety and depression may develop.The aim of this study was to compare the effects of combined decongestive treatment and intermittent pneumatic compression treatment combined with aerobic exercise on pain, quality of life and fatigue in patients with lipedema.

Detailed description: Lipedema is a chronic, progressive and hereditary adipose tissue disorder characterized by an abnormal increase of subcutaneous adipose tissue, especially in the lower extremities. It is often seen in female sex. The main determinants of lipedema are bilateral symmetric swelling of the hypodermis of the legs which are painful with palpation or spontaneous and easy ecchymosis and hematoma with minor trauma.

Lipedema usually begins in the period of hormonal change in adolescence or after a few years and can progress in women during hormone changes such as pregnancy, gynecologic surgery or menopause.

Lipedema is a different diagnosis from obesity, but it can be misdiagnosed as primary obesity due to clinical overlap. In contrast to obesity, lipoedema may not improve with weight loss and does not include the risk of metabolic syndrome such as diabetes, hypertension and dyslipidemia. However, if not treated for lipedema, medical complications such as hypermobility, joint problems, walking difficulties, and psychological complications such as anxiety and depression may develop.

However, if not treated for lipedema, medical complications such as hypermobility, joint problems, walking difficulties and psychological complications such as anxiety and depression may develop.

Treatment for lipedema includes conservative and surgical options. In conservative treatment to control edema, combined decongestive treatment which consists of manual lymphatic drainage and compression bandaging, intermittent pneumatic compression and exercise options are included.

The aim of this study was to compare the effects of combined decongestive treatment and intermittent pneumatic compression treatment combined with aerobic exercise on pain, quality of life and fatigue in patients with lipedema.

Eligibility criteria: Inclusion Criteria:

* Subject diagnosed with lipedema according to the criteria of revised Wold.
* Subject did not participate in any exercise program within the last three months.
* No pregnancy / breastfeeding

Exclusion Criteria:

* History of acute infection, cancer, inflammatory rheumatic / connective tissue diseases
* History of cardiovascular or musculoskeletal problems that may prevent them from participating in the exercise program

Primary outcomes:
measure: Extremity volumetric measurement
timeFrame: 6 weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: 6 weeks
measure: Waist-to-hip ratio
timeFrame: 6 weeks
measure: 6-minute walk test
timeFrame: 6 weeks
measure: Visual analog scale for pain
timeFrame: 6 weeks
measure: Short Form Health Survey 36 (SF-36) physical performance subscore SF-36 contains 36 items which are used to evaluate the quality of life of patients with chronic pain.
timeFrame: 6 weeks
measure: Fatigue Severity Scale
timeFrame: 6 weeks
measure: Beck Depression Inventory
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Tuğba Atan
Study officials:
References:
citation: Reich-Schupke S, Schmeller W, Brauer WJ, Cornely ME, Faerber G, Ludwig M, Lulay G, Miller A, Rapprich S, Richter DF, Schacht V, Schrader K, Stucker M, Ure C. S1 guidelines: Lipedema. J Dtsch Dermatol Ges. 2017 Jul;15(7):758-767. doi: 10.1111/ddg.13036.
citation: WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available.
citation: Canning C, Bartholomew JR. Lipedema. Vasc Med. 2018 Feb;23(1):88-90. doi: 10.1177/1358863X17739698. Epub 2017 Nov 16. No abstract available.
citation: Atan T, Bahar-Ozdemir Y. The Effects of Complete Decongestive Therapy or Intermittent Pneumatic Compression Therapy or Exercise Only in the Treatment of Severe Lipedema: A Randomized Controlled Trial. Lymphat Res Biol. 2021 Feb;19(1):86-95. doi: 10.1089/lrb.2020.0019. Epub 2020 Dec 9.