Physical Condition in Lipedema and Obesity

NCT01759004 | Completed

• 2 other identifiers: NS4NLNij Smellinghe hospital
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipoedema; Obesity

Keywords

lipoedema; obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• walking capacity

  June 2013

Study Arms (2)

patient with lipoedema

ACTIVE COMPARATOR

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

patients with obesity

ACTIVE COMPARATOR

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

Other: volume, muscle strength, physical condition, BMI

Interventions

volume, muscle strength, physical condition, BMI OTHER

phys. condition, muscle strength, volumetry, BMI

patient with lipoedema; patients with obesity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nij Smellinghe Hosptial: lead

Study Sites (1)

Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Drachten, Provincie Friesland, 9202 NN, Netherlands

Location

Related Links

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

MeSH Terms

Conditions

Lipedema; Obesity

Interventions

Muscle Strength; Body Mass Index

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Body Weights and Measures; Body Constitution; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• RJ Damstra, MD PhD

  Nij Smellinghe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist MD PhD

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

NL (1)