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

Comparison of Complete Decongestive Therapy (CDT) With Intermittent Pneumatic Compression (IPK) 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.

Study Overview

• Status: Completed
• Conditions: Lipedema
• Intervention / Treatment: Combination product: Combined decongestive treatment (CDT) & Combined exercise; Combination product: Intermittent pneumatic compression & Combined exercise; Combination product: Combined exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Corum, Turkey, 19100
    • Tuğba Atan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined decongestive treatment & Combined exercise; 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; Combined decongestive treatment consists of manual lymphatic drainage and compression bandaging for 30 sessions.
Experimental: Intermittent pneumatic compression & Combined exercise; 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; Intermittent pneumatic compression for 5 days a week, for 6 weeks (totally, 30 sessions).
Active Comparator: Combined exercise; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hitit University

Publications and helpful links

General Publications

• 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.
• 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.
• Canning C, Bartholomew JR. Lipedema. Vasc Med. 2018 Feb;23(1):88-90. doi: 10.1177/1358863X17739698. Epub 2017 Nov 16. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): December 22, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 18, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Intermittent pneumatic compression; Lipedema; Combined decongestive treatment
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: 19-KAEK-062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No