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

Lipedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924999
• Other study ID #: 19-KAEK-062
• Status: Completed
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: December 22, 2019

Study information

• Verified date: January 2020
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lipedema

Intervention

Combination Product:
• Combined decongestive treatment (CDT) & Combined exercise
Combined decongestive treatment consists of manual lymphatic drainage and compression bandaging for 30 sessions.
• Intermittent pneumatic compression & Combined exercise
Intermittent pneumatic compression for 5 days a week, for 6 weeks (totally, 30 sessions).
• Combined exercise
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.

Locations

Country	Name	City	State
Turkey	Tugba Atan	Corum

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Canning C, Bartholomew JR. Lipedema. Vasc Med. 2018 Feb;23(1):88-90. doi: 10.1177/1358863X17739698. Epub 2017 Nov 16. Review. — View 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, Stücker M, Ure C. S1 guidelines: Lipedema. J Dtsch Dermatol Ges. 2017 Jul;15(7):758-767. doi: 10.1111/ddg.13036. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extremity volumetric measurement	Pythagorean theorem in the excel program.; Pythagorean theorem will automatically calculate volumetric calculation.	6 weeks
Secondary	Waist circumference	Waist circumference	6 weeks
Secondary	Waist-to-hip ratio	Waist-to-hip ratio	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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