Physical Condition in Lipedema and Obesity

Muscle Strength and Physical Fitness in Patients With Lipedema and Obesity: a Prospective Cross-sectional Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Lipoedema
• Intervention / Treatment: Other: volume, muscle strength, physical condition, BMI

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Drachten, Friesland, Netherlands, 9202 NN
      • Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patient with lipoedema; 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; phys. condition, muscle strength, volumetry, BMI
Active Comparator: patients with obesity; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	June 2013

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	June 2013

Collaborators and Investigators

• Sponsor: Nij Smellinghe Hosptial
• Investigators: Principal Investigator: RJ Damstra, MD PhD, Nij Smellinghe Hospital

Publications and helpful links

Helpful Links

• The foundation related to the expert centre organizing research
• General website form the Nij Smellinghe hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 24, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: obesity; lipoedema
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Connective Tissue Diseases; Obesity; Lipedema
• Other Study ID Numbers: NS4NL; Nij Smellinghe hospital (Other Identifier: Nij Smellinghe hospital)