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出境医 / 临床实验 / Comparison of Complete Decongestive Therapy With Intermittent Pneumatic Compression for Treatment of Lipedema

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

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 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

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
Layout table for study information
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
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
Layout table for eligibility information
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
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

Locations
Layout table for location information
Turkey
Tuğba Atan
Corum, Turkey, 19100
Sponsors and Collaborators
Hitit University
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
 (submitted: January 18, 2020)
Extremity volumetric measurement [ Time Frame: 6 weeks ]
Pythagorean theorem in the excel program. Pythagorean theorem will automatically calculate volumetric calculation.
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2020)
  • Waist circumference [ Time Frame: 6 weeks ]
    Waist circumference
  • Waist-to-hip ratio [ Time Frame: 6 weeks ]
    Waist-to-hip ratio
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Extremity volumetric measurement [ Time Frame: 6 weeks ]
    Pythagorean theorem in the excel program. Pythagorean theorem will automatically calculate volumetric calculation.
  • Waist-to-height ratio [ Time Frame: 6 weeks ]
    Waist-to-height ratio
  • Waist-to-hip ratio [ Time Frame: 6 weeks ]
    Waist-to-hip ratio
  • 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.
  • Visual analog scale for pain (VAS-pain) [ Time Frame: 6 weeks ]
    Pain intensity was measured with VAS which is used to measure musculoskeletal pain with very good reliability and validity.
  • Fatigue Severity Scale [ Time Frame: 6 weeks ]
    It assesses the severity of fatigue during the last week in a 9-item questionnaire
  • Beck Depression Inventory [ Time Frame: 6 weeks ]
    It is used to evaluate the severity of depression.
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.

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
Condition  ICMJE Lipedema
Intervention  ICMJE
  • Combination Product: Combined decongestive treatment (CDT) & Combined exercise
    Combined decongestive treatment consists of manual lymphatic drainage and compression bandaging for 30 sessions.
  • Combination Product: Intermittent pneumatic compression & Combined exercise
    Intermittent pneumatic compression for 5 days a week, for 6 weeks (totally, 30 sessions).
  • 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.
Study Arms  ICMJE
  • 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.

    Intervention: Combination Product: Combined decongestive treatment (CDT) & Combined exercise
  • 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.

    Intervention: Combination Product: Intermittent pneumatic compression & Combined exercise
  • 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.
    Intervention: Combination Product: Combined exercise
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, Stücker 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.
  • Canning C, Bartholomew JR. Lipedema. Vasc Med. 2018 Feb;23(1):88-90. doi: 10.1177/1358863X17739698. Epub 2017 Nov 16. Review.
  • Atan T, Bahar-Özdemir 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: female sex
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP