Physical Condition in Lipedema and Obesity

• ClinicalTrials.gov Identifier: NCT01759004
• Recruitment Status: Completed
• First Posted: January 1, 2013
• Last Update Posted: December 6, 2013
• Sponsor: Nij Smellinghe Hosptial
• Information provided by (Responsible Party): R.J. Damstra, Nij Smellinghe Hosptial

Tracking Information

• First Submitted Date: December 4, 2012
• First Posted Date: January 1, 2013
• Last Update Posted Date: December 6, 2013
• Study Start Date: December 2012
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 24, 2012)

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. [ Time Frame: June 2013 ]

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 24, 2012)

walking capacity [ Time Frame: June 2013 ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Lipoedema
• Obesity

Intervention

Other: volume, muscle strength, physical condition, BMI

phys. condition, muscle strength, volumetry, BMI

Study Arms

• 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

  Intervention: Other: volume, muscle strength, physical condition, BMI
• Active Comparator: patients with obesity

  Obesity group:

  • BMI ≥ 30
  • women
  • age ≥ 18 years

  clinimetrics: volume, muscle strength, physical condition, BMI

  Intervention: Other: volume, muscle strength, physical condition, BMI

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 24, 2012): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01759004
• Other Study ID Numbers: NS4NL; Nij Smellinghe hospital ( Other Identifier: Nij Smellinghe hospital )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: R.J. Damstra, Nij Smellinghe Hosptial
• Original Responsible Party: Same as current
• Current Study Sponsor: Nij Smellinghe Hosptial
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: RJ Damstra, MD PhD; Nij Smellinghe Hospital

• PRS Account: Nij Smellinghe Hosptial
• Verification Date: December 2013