Comparison of Complete Decongestive Therapy With Intermittent Pneumatic Compression for Treatment of Lipedema

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Complete Decongestive Therapy (CDT) With Intermittent Pneumatic Compression (IPK) for Treatment of Lipedema

Conditions
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Lipedema

Intervention / Treatment
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* Combination Product: Combined decongestive treatment (CDT) & Combined exercise
* Combination Product: Intermittent pneumatic compression & Combined exercise
* Combination Product: Combined exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined decongestive treatment & Combined exercise<br>Combined decongestive treatment consists of manual lymphatic drainage and compression bandaging for 5 days a week, for 6 weeks (totally, 30 sessions). All participants received 30 minutes aerobic exercise program including treadmill training consisted of a 5-minute warm-up and cool-down period and 25-minute submaximal aerobic exercise 5 days a week, for 6 weeks. Exercise intensity was calculated from the initial 6MWT. Each session was completed with 15 minutes of strengthening and stretching exercises. | Combination Product: Combined decongestive treatment (CDT) & Combined exercise<br>* Combined decongestive treatment consists of manual lymphatic drainage and compression bandaging for 30 sessions.<br>|
| Experimental: Intermittent pneumatic compression & Combined exercise<br>Intermittent pneumatic compression for 5 days a week, for 6 weeks (totally, 30 sessions). All participants received 30 minutes aerobic exercise program including treadmill training consisted of a 5-minute warm-up and cool-down period and 25-minute submaximal aerobic exercise 5 days a week, for 6 weeks. Exercise intensity was calculated from the initial 6MWT. Each session was completed with 15 minutes of strengthening and stretching exercises. | Combination Product: Intermittent pneumatic compression & Combined exercise<br>* Intermittent pneumatic compression for 5 days a week, for 6 weeks (totally, 30 sessions).<br>|
| Active Comparator: Combined exercise<br>All participants received 30 minutes aerobic exercise program including treadmill training consisted of a 5-minute warm-up and cool-down period and 25-minute submaximal aerobic exercise 5 days a week, for 6 weeks. Exercise intensity was calculated from the initial 6MWT. Each session was completed with 15 minutes of strengthening and stretching exercises. | Combination Product: Combined exercise<br>* 30 minutes aerobic exercise program including treadmill training consisted of a 5-minute warm-up and cool-down period and 25-minute submaximal aerobic exercise 5 days a week, for 6 weeks. Exercise intensity was calculated from the initial 6MWT. Each session was completed with 15 minutes of strengthening and stretching exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extremity volumetric measurement | Pythagorean theorem in the excel program. Pythagorean theorem will automatically calculate volumetric calculation. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference | 6 weeks | 
| Waist-to-hip ratio | Waist-to-hip ratio | 6 weeks | 
| 6-minute walk test | 6-Minute Walk Test is a submaximal exercise test usually corresponding to 80% of a subject's maximum heart rate and is used to assess functional capacity and treatment response. | 6 weeks | 
| Visual analog scale for pain | Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. | 6 weeks | 
| 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. | 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. | 6 weeks | 
| Fatigue Severity Scale | Fatigue Severity Scale assesses the severity of fatigue during the last week in a 9-item questionnaire (1= strongly disagree, 7= strongly agree). Total score ranges from 9 to 63, with higher scores representing greater fatigue. | 6 weeks | 
| Beck Depression Inventory | This is a 21-item self-report questionnaire evaluating the presence and severity of depressive symptoms in the vegetative, emotional, cognitive and motivational domains. Scores of each item ranges from 0 to 3, higher scores mean higher risk of depression. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipedema, Combined decongestive treatment, Intermittent pneumatic compression