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AzTrials

LipedemaNCT03924999

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

A study testing Combined decongestive treatment (CDT) & Combined exercise, Intermittent pneumatic compression & Combined exercise and Combined exercise in people with Lipedema, run by Hitit University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Lipedema
What is being tested?
Combined decongestive treatment (CDT) & Combined exercise, Intermittent pneumatic compression & Combined exercise and Combined exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Apr 2019to 22 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Tuğba Atan

    Çorum, 19100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions
Lipedema
Being tested
Combined decongestive treatment (CDT) & Combined exercise, Intermittent pneumatic compression & Combined exercise, Combined exercise
Keywords
Lipedema, Combined decongestive treatment, Intermittent pneumatic compression
Medical subject headings
Lipedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined decongestive treatment (CDT) & Combined exerciseCombination product

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

  • Intermittent pneumatic compression & Combined exerciseCombination product

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

  • Combined exerciseCombination product

    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 groups in NCT03924999
Study groupRoleWhat they receive
Combined decongestive treatment & Combined exerciseExperimentalCombined 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.
Receives: Combination Product: Combined decongestive treatment (CDT) & Combined exercise
Intermittent pneumatic compression & Combined exerciseExperimentalIntermittent 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.
Receives: Combination Product: Intermittent pneumatic compression & Combined exercise
Combined exerciseActive comparatorAll 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.
Receives: Combination Product: Combined exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extremity volumetric measurement

    Pythagorean theorem in the excel program.

    Pythagorean theorem will automatically calculate volumetric calculation.

    Measured: 6 weeks

Secondary outcomes (7)

  1. Waist circumference

    Waist circumference

    Measured: 6 weeks

  2. Waist-to-hip ratio

    Waist-to-hip ratio

    Measured: 6 weeks

  3. 6-minute walk test

    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.

    Measured: 6 weeks

  4. Visual analog scale for pain

    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.

    Measured: 6 weeks

  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.

    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.

    Measured: 6 weeks

  6. Fatigue Severity Scale

    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.

    Measured: 6 weeks

  7. Beck Depression Inventory

    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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2019
  2. Study start22 Apr 2019
  3. Primary completion22 Nov 2019
  4. Study completion22 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03924999
Sponsor's protocol ID
19-KAEK-062
Status last verified
Jan 2020
First submitted
22 Apr 2019
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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, Stucker M, Ure C. S1 guidelines: Lipedema. J Dtsch Dermatol Ges. 2017 Jul;15(7):758-767. doi: 10.1111/ddg.13036.

    PubMed 28677175

  • 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. doi: 10.7326/0003-4819-34-5-1243. No abstract available.

    PubMed 14830102

  • Canning C, Bartholomew JR. Lipedema. Vasc Med. 2018 Feb;23(1):88-90. doi: 10.1177/1358863X17739698. Epub 2017 Nov 16. No abstract available.

    PubMed 29143577

  • Atan T, Bahar-Ozdemir 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.

    PubMed 33297826

Questions about this trial

What is this clinical trial studying?

A study testing Combined decongestive treatment (CDT) & Combined exercise, Intermittent pneumatic compression & Combined exercise and Combined exercise in people with Lipedema, run by Hitit University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extremity volumetric measurement (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03924999, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.

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