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Physical Condition in Lipedema and Obesity

Primary Purpose

Lipoedema, Obesity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
volume, muscle strength, physical condition, BMI
Sponsored by
Nij Smellinghe Hosptial
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lipoedema focused on measuring lipoedema, obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Lipedema group:

  • diagnosed with lipedema following the criteria of Wold et al3
  • women
  • age ≥ 18 years

Obesity group:

  • BMI ≥ 30
  • women
  • age ≥ 18 years

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

Lipedema group:

- none

Obesity group:

- an obesity intervention with physical training in the ≤12 months prior to the measurement

Sites / Locations

  • Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

patient with lipoedema

patients with obesity

Arm Description

Lipedema group: diagnosed with lipedema following the criteria of Wold women age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI

Obesity group: BMI ≥ 30 women age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI

Outcomes

Primary Outcome Measures

The main determinant of this study is a muscle strength test of the Quadriceps muscle of the left and right leg measured with the MircoFET.
Muscle strength will be measured with the MicroFET. This test is performed when de patient is sitting. The patient is instructed to perform knee extension three times for each leg. The test result is de average score of each leg. The MicroFET has been shown to be a valid measurement with the break-method.14,15 Schaubert et al.15 and Bohannon et al.14 looked at the reliability of MicroFET measurements and found a good Intraclass Correlation Coefficient (ICC) values of 0.807-0.97115 and ICC>.097014 respectively. The test procedure of the break-method is described in Appendix 1).

Secondary Outcome Measures

walking capacity
After performing the muscle strength test, the participants will be asked to perform a test for physical fitness, knowing the Six Minute Walk Test (6MWT). Walking capacity will be measured with the 6MWT. This standardized test is performed on a 30 meters course where every five meter is marked. The patient will be instructed to cross a maximum distance in six minutes with a possibility to stop or rest if necessary.16 The result is the walking distance in meters (m) after six minutes (with five meter exactness). The 6MWT is a good test for functional activity. De walking distance performed with the 6MWT gives a good sight in the amount of activities in daily living (ADL) of the performer.17 Rjeski et al.17 found a good validity and correlation with the VO2max (r=0.64) for participants with chronic obstructive pulmonary disease (COPD). The test-retest reliability of this test is good (ICC 0.94).18

Full Information

First Posted
December 4, 2012
Last Updated
December 4, 2013
Sponsor
Nij Smellinghe Hosptial
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1. Study Identification

Unique Protocol Identification Number
NCT01759004
Brief Title
Physical Condition in Lipedema and Obesity
Official Title
Muscle Strength and Physical Fitness in Patients With Lipedema and Obesity: a Prospective Cross-sectional Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nij Smellinghe Hosptial

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The diagnosis of lipoedema and obesity are often mixed up, unclear stated and often there is a misdiagnosis. The primary aim is to investigate whether there is a difference in muscle strength between women with lipedema and women with obesity. The secondary aim is to investigate whether there is a difference in physical fitness between women with lipedema and women with obesity.
Detailed Description
Lipedema is a genetically mediated disorder of adipose tissue that occurs exclusively in women. Lipedema is an under-recognized condition, often misdiagnosed as lymfedema or dismissed as simple obesity. The diagnosis of lipedema is a clinical diagnosis and may be challenging to determine among patients who are obese. Measurements of muscle strength and physical fitness may give more clarity to differentiate between lipedema and obesity. This may lead to improvements in the criteria of diagnosing lipedema. The research question of the study is: Is there a difference in muscle strength between adult women with lipedema and adult women with obesity? In this study 40 patients will be studied; 20 patients in every group. Besides the general data as length, weight, age, abdominal circumference, volume of the legs additional muscle strength and physical fitness of women with lipedema and women with obesity will be measured and analysis. This study doesn't involve a negligible risk for participants. The study will not have direct benefit for the participants, but may be useful in giving more clarity in defining the phenotype for patients with lipedema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipoedema, Obesity
Keywords
lipoedema, obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient with lipoedema
Arm Type
Active Comparator
Arm Description
Lipedema group: diagnosed with lipedema following the criteria of Wold women age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI
Arm Title
patients with obesity
Arm Type
Active Comparator
Arm Description
Obesity group: BMI ≥ 30 women age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI
Intervention Type
Other
Intervention Name(s)
volume, muscle strength, physical condition, BMI
Intervention Description
phys. condition, muscle strength, volumetry, BMI
Primary Outcome Measure Information:
Title
The main determinant of this study is a muscle strength test of the Quadriceps muscle of the left and right leg measured with the MircoFET.
Description
Muscle strength will be measured with the MicroFET. This test is performed when de patient is sitting. The patient is instructed to perform knee extension three times for each leg. The test result is de average score of each leg. The MicroFET has been shown to be a valid measurement with the break-method.14,15 Schaubert et al.15 and Bohannon et al.14 looked at the reliability of MicroFET measurements and found a good Intraclass Correlation Coefficient (ICC) values of 0.807-0.97115 and ICC>.097014 respectively. The test procedure of the break-method is described in Appendix 1).
Time Frame
June 2013
Secondary Outcome Measure Information:
Title
walking capacity
Description
After performing the muscle strength test, the participants will be asked to perform a test for physical fitness, knowing the Six Minute Walk Test (6MWT). Walking capacity will be measured with the 6MWT. This standardized test is performed on a 30 meters course where every five meter is marked. The patient will be instructed to cross a maximum distance in six minutes with a possibility to stop or rest if necessary.16 The result is the walking distance in meters (m) after six minutes (with five meter exactness). The 6MWT is a good test for functional activity. De walking distance performed with the 6MWT gives a good sight in the amount of activities in daily living (ADL) of the performer.17 Rjeski et al.17 found a good validity and correlation with the VO2max (r=0.64) for participants with chronic obstructive pulmonary disease (COPD). The test-retest reliability of this test is good (ICC 0.94).18
Time Frame
June 2013

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Lipedema group: diagnosed with lipedema following the criteria of Wold et al3 women age ≥ 18 years Obesity group: BMI ≥ 30 women age ≥ 18 years Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Lipedema group: - none Obesity group: - an obesity intervention with physical training in the ≤12 months prior to the measurement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RJ Damstra, MD PhD
Organizational Affiliation
Nij Smellinghe Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
City
Drachten
State/Province
Friesland
ZIP/Postal Code
9202 NN
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.nijsmellinghe.nl
Description
General website form the Nij Smellinghe hospital
URL
http://www.slcn.nl
Description
The foundation related to the expert centre organizing research

Learn more about this trial

Physical Condition in Lipedema and Obesity

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