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

  • Clinicaltrials.gov identifier

    NCT03924999

  • Recruitment Status

    Completed

  • First Posted

    April 23, 2019

  • Last update posted

    January 22, 2020

Study Description

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.

  • Condition or Disease:Lipedema
  • Intervention/Treatment: Combination Product: Combined decongestive treatment (CDT) & Combined exercise
    Combination Product: Intermittent pneumatic compression & Combined exercise
    Combination Product: Combined exercise
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 33 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Treatment
  • Official Title: Comparison of Complete Decongestive Therapy (CDT) With Intermittent Pneumatic Compression (IPK) for Treatment of Lipedema
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: November 2019
  • Actual Study Completion Date: December 2019

Arms and interventions

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.

Outcome Measures

  • Primary Outcome Measures: 1. Extremity volumetric measurement [ Time Frame: 6 weeks ]
    Pythagorean theorem in the excel program. Pythagorean theorem will automatically calculate volumetric calculation.
  • Secondary Outcome Measures: 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Locations

Turkey
Tuğba Atan
Corum

Sponsors and Collaborators

Hitit University

More Information