| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lipedema | Combination Product: Combined decongestive treatment (CDT) & Combined exercise Combination Product: Intermittent pneumatic compression & Combined exercise Combination Product: Combined exercise | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 33 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Masking Description: | single blinded |
| 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 22, 2019 |
| Actual Primary Completion Date : | November 22, 2019 |
| Actual Study Completion Date : | December 22, 2019 |
| 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.
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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).
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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.
|
Pythagorean theorem in the excel program.
Pythagorean theorem will automatically calculate volumetric calculation.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | female sex |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Turkey | |
| Tuğba Atan | |
| Corum, Turkey, 19100 | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 22, 2019 | ||||||
| First Posted Date ICMJE | April 23, 2019 | ||||||
| Last Update Posted Date | January 22, 2020 | ||||||
| Actual Study Start Date ICMJE | April 22, 2019 | ||||||
| Actual Primary Completion Date | November 22, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Extremity volumetric measurement [ Time Frame: 6 weeks ] Pythagorean theorem in the excel program.
Pythagorean theorem will automatically calculate volumetric calculation.
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| Original Primary Outcome Measures ICMJE |
Short Form Health Survey 36 (SF-36) physical performance subscore [ Time Frame: 6 weeks ] SF-36 contains 36 items which are used to evaluate the quality of life of patients with chronic pain.
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparison of Complete Decongestive Therapy With Intermittent Pneumatic Compression for Treatment of Lipedema | ||||||
| Official Title ICMJE | Comparison of Complete Decongestive Therapy (CDT) With Intermittent Pneumatic Compression (IPK) for Treatment of Lipedema | ||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Masking Description: single blinded Primary Purpose: Treatment
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| Condition ICMJE | Lipedema | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
33 | ||||||
| Original Estimated Enrollment ICMJE |
30 | ||||||
| Actual Study Completion Date ICMJE | December 22, 2019 | ||||||
| Actual Primary Completion Date | November 22, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Turkey | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03924999 | ||||||
| Other Study ID Numbers ICMJE | 19-KAEK-062 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Tuğba Atan, Hitit University | ||||||
| Study Sponsor ICMJE | Hitit University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Hitit University | ||||||
| Verification Date | January 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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