Comparison of Complete Decongestive Therapy With Intermittent Pneumatic Compression for Treatment of Lipedema
- Conditions
- Lipedema
- Interventions
- Combination Product: Intermittent pneumatic compression & Combined exerciseCombination Product: Combined decongestive treatment (CDT) & Combined exerciseCombination Product: Combined exercise
- Registration Number
- NCT03924999
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 33
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent pneumatic compression & Combined exercise 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. Combined decongestive treatment & Combined exercise Combined decongestive treatment (CDT) & 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. Combined exercise 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.
- Primary Outcome Measures
Name Time Method Extremity volumetric measurement 6 weeks Pythagorean theorem in the excel program.
Pythagorean theorem will automatically calculate volumetric calculation.
- Secondary Outcome Measures
Name Time Method Fatigue Severity Scale 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.
Waist circumference 6 weeks Waist circumference
Visual analog scale for pain 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.
Waist-to-hip ratio 6 weeks Waist-to-hip ratio
6-minute walk test 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.
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 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.
Beck Depression Inventory 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.
Trial Locations
- Locations (1)
Tuğba Atan
🇹🇷Corum, Turkey