NCT03924999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

April 22, 2019

Last Update Submit

January 18, 2020

Conditions

Lipedema

Keywords

LipedemaCombined decongestive treatmentIntermittent pneumatic compression

Outcome Measures

Primary Outcomes (1)

  • Extremity volumetric measurement

    Pythagorean theorem in the excel program. Pythagorean theorem will automatically calculate volumetric calculation.

    6 weeks

Secondary Outcomes (7)

  • Waist circumference

    6 weeks

  • Waist-to-hip ratio

    6 weeks

  • 6-minute walk test

    6 weeks

  • Visual analog scale for pain

    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 weeks

  • +2 more secondary outcomes

Study Arms (3)

Combined decongestive treatment & Combined exercise

EXPERIMENTAL

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

Intermittent pneumatic compression & Combined exercise

EXPERIMENTAL

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

Combined exercise

ACTIVE COMPARATOR

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

Interventions

Combined decongestive treatment (CDT) & Combined exerciseCOMBINATION_PRODUCT

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

Combined decongestive treatment & Combined exercise
Intermittent pneumatic compression & Combined exerciseCOMBINATION_PRODUCT

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

Intermittent pneumatic compression & Combined exercise
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.

Combined exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale sex
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 28677175BACKGROUND

  • 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.

    PMID: 14830102BACKGROUND

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

    PMID: 29143577BACKGROUND

  • 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.

    PMID: 33297826DERIVED

MeSH Terms

Conditions

Lipedema

Interventions

carbohydrate-deficient transferrin

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 23, 2019

Study Start

April 22, 2019

Primary Completion

November 22, 2019

Study Completion

December 22, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)