An interventional study of volume, muscle strength, physical condition, BMI in Lipoedema and Obesity, sponsored by Nij Smellinghe Hosptial. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-06.
Sponsored by Nij Smellinghe Hosptial · Not applicable, Interventional, and Diagnostic
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.
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.
78 studies on the registry are indexed under Lipedema; 28 are open to participants now.
This study's enrollment of 40 is above the median of 34 across 37 interventional studies indexed under Lipedema.
Browse Lipedema studies →Nij Smellinghe Hosptial is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Lipedema group:
Obesity group:
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Lipedema group:
Obesity group:
Lipedema group: * diagnosed with lipedema following the criteria of Wold * women * age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI
Other: volume, muscle strength, physical condition, BMI
Obesity group: * BMI ≥ 30 * women * age ≥ 18 years clinimetrics: volume, muscle strength, physical condition, BMI
Other: volume, muscle strength, physical condition, BMI
phys. condition, muscle strength, volumetry, BMI
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).
Time frame: June 2013
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
Time frame: June 2013
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Nij Smellinghe Hosptial