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

NCT ID: NCT03924999

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2019-12-22

Brief Summary

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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

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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

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Lipedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
single blinded

Study Groups

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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.

Group Type EXPERIMENTAL

Combined decongestive treatment (CDT) & Combined exercise

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type EXPERIMENTAL

Intermittent pneumatic compression & Combined exercise

Intervention Type COMBINATION_PRODUCT

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

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.

Group Type ACTIVE_COMPARATOR

Combined exercise

Intervention Type COMBINATION_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.

Interventions

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Combined decongestive treatment (CDT) & Combined exercise

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

Intervention Type COMBINATION_PRODUCT

Intermittent pneumatic compression & Combined exercise

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

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hitit University

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Atan

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tuğba Atan

Çorum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28677175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14830102 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 29143577 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33297826 (View on PubMed)

Other Identifiers

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19-KAEK-062

Identifier Type: -

Identifier Source: org_study_id

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