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

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

Sponsors

Lead sponsor: Hitit University

Source Hitit University
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.

Overall Status Completed
Start Date April 22, 2019
Completion Date December 22, 2019
Primary Completion Date November 22, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Extremity volumetric measurement 6 weeks
Secondary Outcome
Measure Time Frame
Waist circumference 6 weeks
Waist-to-hip ratio 6 weeks
6-minute walk test 6 weeks
Visual analog scale for pain 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 weeks
Fatigue Severity Scale 6 weeks
Beck Depression Inventory 6 weeks
Enrollment 33
Condition
Intervention

Intervention type: Combination Product

Intervention name: Combined decongestive treatment (CDT) & Combined exercise

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

Arm group label: Combined decongestive treatment & Combined exercise

Intervention type: Combination Product

Intervention name: Intermittent pneumatic compression & Combined exercise

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

Arm group label: Intermittent pneumatic compression & Combined exercise

Intervention type: Combination Product

Intervention name: Combined exercise

Description: 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.

Arm group label: Combined exercise

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

Gender: Female

Gender based: Yes

Gender description: female sex

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Location
facility Tuğba Atan
Location Countries

Turkey

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Hitit University

Investigator full name: Tuğba Atan

Investigator title: Assoc. Prof.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Combined decongestive treatment & Combined exercise

Arm group type: Experimental

Description: 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.

Arm group label: Intermittent pneumatic compression & Combined exercise

Arm group type: Experimental

Description: 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.

Arm group label: Combined exercise

Arm group type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Investigator)

Masking description: single blinded

Source: ClinicalTrials.gov