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NCT Number: NCT03924999

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

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.

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Key information

Conditions

Lipedema Connective Tissue Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined decongestive treatment (CDT) & Combined exercise

Combination Product

Combined decongestive treatment consists of manual lymphatic drainage and compression bandaging for 30 sessions.

Intermittent pneumatic compression & Combined exercise

Combination Product

Intermittent pneumatic compression for 5 days a week, for 6 weeks (totally, 30 sessions).

Combined exercise

Combination Product

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.

Primary outcomes

  1. Extremity volumetric measurement

    Time frame: 6 weeks

    Pythagorean theorem in the excel program.

    Pythagorean theorem will automatically calculate volumetric calculation.

Secondary outcomes

  1. Waist circumference

    Time frame: 6 weeks

    Waist circumference

  2. Waist-to-hip ratio

    Time frame: 6 weeks

    Waist-to-hip ratio

  3. 6-minute walk test

    Time frame: 6 weeks

    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.

  4. Visual analog scale for pain

    Time frame: 6 weeks

    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.

  5. 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.

    Time frame: 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.

  6. Fatigue Severity Scale

    Time frame: 6 weeks

    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.

  7. Beck Depression Inventory

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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